当前位置： SCI文献检索 > JOURNAL OF CLINICAL PHARMACOLOGY期刊下所有文献 > Pharmacokinetics and pharmacodynamics of figitumumab, a monoclonal antibody targeting the insulin-like growth factor 1 receptor, in healthy participants.

Pharmacokinetics and pharmacodynamics of figitumumab, a monoclonal antibody targeting the insulin-like growth factor 1 receptor, in healthy participants.

Abstract：

:This study determined the pharmacokinetics (PK) of figitumumab and its effects on insulin-like growth factor (IGF) axis-related biomarkers, following a single intravenous dose (10 [n = 16] and 20 [n = 12] mg/kg) in healthy adults. Serial blood sampling for PK and biomarkers was conducted up to 84 days postdose. A dose increase from 10 to 20 mg/kg led to 1.9- and 2.4-fold increases in mean C(max) and AUC∞, respectively. Median disposition half-life was 21.1 and 27.8 days at 10 and 20 mg/kg, respectively. At 10 and 20 mg/kg, figitumumab increased total IGF-1, free IGF-1, IGF binding protein (IGFBP)-3, and insulin by 4.1- and 4.8-, 8.3- and 12.1-, 2.4- and 2.9-, and 7.3- and 9.8-fold, respectively; increases were sustained throughout the 84-day period. There was a slight and transient elevation in IGF-2. Mean plasma glucose increased by 18% and 16% at 10 and 20 mg/kg, respectively. Most treatment-related adverse events were mild in severity; the most common included dry eye (n = 9) and ocular hyperemia (n = 9) in the 20-mg/kg group. No antidrug antibodies were detected. Overall, figitumumab (10 or 20 mg/kg) demonstrated PK properties typical of IgG2 antibodies and produced substantial and sustained increases in IGF-1 (total and free), IGFBP-3, and insulin.

journal_name

J Clin Pharmacol

journal_title

Journal of clinical pharmacology

authors

Yin D,Sleight B,Alvey C,Hansson AG,Bello A

doi

10.1177/0091270011432934

subject

Has Abstract

pub_date

2013-01-01 00:00:00

pages

21-8

issue

1

eissn

0091-2700

issn

1552-4604

journal_volume

53

pub_type

杂志文章

相关文献

JOURNAL OF CLINICAL PHARMACOLOGY文献大全
  • Isoproterenol sensitivity and total body clearance of propranolol in hypertensive patients.

    abstract：:The isoproterenol sensitivity (dose-response curve) and the total body clearance of propranolol were measured in 80 men including 15 normal subjects and 65 essential hypertensive patients (20 borderline and 45 permanent hypertensives). The critical dose of isoproterenol was found to be directly correlated to weight (P...

    journal_title：Journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1002/j.1552-4604.1976.tb01514.x

    authors： London GM,Safar ME,Weiss YA,Milliez PL

    更新日期：1976-04-01 00:00:00

  • A study of the transplacental transfer and the mammary excretion of cefoxitin in humans.

    abstract：:Cefoxitin is a new semisynthetic cephamycin derivative with broad bactericidal activities. In order to determine the extent of the transplacental transfer of cefoxitin, 35 pregnant women received 1 Gm cefoxitin intramuscularly 15 to 180 minutes before normal or Caesarean delivery. Cefoxitin was measured microbiologica...

    journal_title：Journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1002/j.1552-4604.1981.tb05653.x

    authors： Dubois M,Delapierre D,Chanteux L,Demonty J,Lambotte R,Kramp R,Dresse A

    更新日期：1981-11-01 00:00:00

  • Safety, tolerability, QTc evaluation, and pharmacokinetics of single and multiple doses of enzastaurin HCl (LY317615), a protein kinase C-beta inhibitor, in healthy subjects.

    abstract：:The safety, tolerability, and pharmacokinetics of orally administered enzastaurin were evaluated in 2 placebo-controlled, dose escalation studies in healthy subjects. In the first human dose study, single doses (2-400 mg) were evaluated, with 22 subjects receiving enzastaurin. The mean half-lives of enzastaurin and it...

    journal_title：Journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1177/0091270007304775

    authors： Welch PA,Sinha VP,Cleverly AL,Darstein C,Flanagan SD,Musib LC

    更新日期：2007-09-01 00:00:00

  • Nifedipine kinetics and bioavailability after single intravenous and oral doses in normal subjects.

    abstract：:Nifedipine kinetics have not been described in clinically relevant detail because of difficulties in formulating a stable preparation for intravenous use and lack of a specific and sensitive assay for plasma nifedipine. We recently developed a gas-chromatographic method and determined conditions in which nifedipine co...

    journal_title：Journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1002/j.1552-4604.1983.tb02720.x

    authors： Foster TS,Hamann SR,Richards VR,Bryant PJ,Graves DA,McAllister RG

    更新日期：1983-04-01 00:00:00

  • Effect of nighttime anisotropine methyl bromide of duodenal ulcer healing and pain: a double-blind controlled trial.

    abstract：:Anisotropine methyl bromide, an anticholinergic, 80 mg given orally at 8 P.M., suppresses gastric acid secretion through the night without significant side effects. Thirty patients with endoscopy-proved symptomatic duodenal ulcer disease completed a randomized, double-blind, placebo-controlled trial of nighttime aniso...

    journal_title：Journal of clinical pharmacology

    pub_type： 临床试验,杂志文章,随机对照试验

    doi：10.1002/j.1552-4604.1978.tb01607.x

    authors： Bowers JH,Forbes JA,Freston JW

    更新日期：1978-07-01 00:00:00

  • Diurnal variation in the pharmacokinetics of nizatidine in healthy volunteers and in patients with peptic ulcer disease.

    abstract：:Six healthy volunteers and six patients with asymptomatic duodenal ulcer disease received placebo or 300 mg nizatidine once at night or twice daily (morning and evening) for a week in a random, cross-over fashion. Steady-state serum nizatidine concentrations and gastric pH were measured over a 24-hour period. No signi...

    journal_title：Journal of clinical pharmacology

    pub_type： 临床试验,杂志文章,随机对照试验

    doi：10.1002/j.1552-4604.1995.tb04029.x

    authors： Jamali F,Thomson AB,Kirdeikis P,Tavernini M,Zuk L,Marriage B,Simpson I,Mahachai V

    更新日期：1995-11-01 00:00:00

  • Short- and long-term effects of spirapril on renal hemodynamics in patients with essential hypertension.

    abstract：:Sixteen essential hypertensive patients were entered into a protocol assessing the effect of Spirapril, an angiotensin-converting enzyme (ACE) inhibitor, on blood pressure, the renin-aldosterone system, and renal function. Specifically monitored before, during 6 weeks, and 6 months of Spirapril therapy were plasma ren...

    journal_title：Journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1002/j.1552-4604.1993.tb04668.x

    authors： Reams GP,Lau A,Knaus V,Bauer JH

    更新日期：1993-04-01 00:00:00

  • The effects of colesevelam HCl on the single-dose pharmacokinetics of glimepiride, extended-release glipizide, and olmesartan medoxomil.

    abstract：:Bile acid sequestrants can potentially bind to concomitant drugs. Single-dose studies evaluated the effects of colesevelam on the pharmacokinetics of glimepiride, glipizide extended-release (ER), and olmesartan medoxomil. Each study enrolled healthy subjects aged 18-45 years. The olmesartan medoxomil study used a rand...

    journal_title：Journal of clinical pharmacology

    pub_type： 杂志文章,随机对照试验

    doi：10.1002/jcph.180

    authors： He L,Wickremasingha P,Lee J,Tao B,Mendell-Harary J,Walker J,Wight D

    更新日期：2014-01-01 00:00:00

  • Safety, tolerability, pharmacokinetics, and pharmacodynamic properties of taranabant, a novel selective cannabinoid-1 receptor inverse agonist, for the treatment of obesity: results from a double-blind, placebo-controlled, single oral dose study in health

    abstract：:Taranabant is a novel cannabinoid CB-1 receptor (CB1R) inverse agonist in clinical development for the treatment of obesity. This double-blind, randomized, placebo-controlled, single oral dose study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of taranabant (0.5-600 mg) in 24 healthy male...

    journal_title：Journal of clinical pharmacology

    pub_type： 杂志文章,随机对照试验

    doi：10.1177/0091270008314467

    authors： Addy C,Li S,Agrawal N,Stone J,Majumdar A,Zhong L,Li H,Yuan J,Maes A,Rothenberg P,Cote J,Rosko K,Cummings C,Warrington S,Boyce M,Gottesdiener K,Stoch A,Wagner J

    更新日期：2008-04-01 00:00:00

  • Are patients reliable when self-reporting medication use? Validation of structured drug interviews and home visits by drug analysis and prescription data in acutely hospitalized patients.

    abstract：:The medication history among hospitalized patients often relies on patients' self-reports due to insufficient communication between health care professionals. The aim of the present study was to estimate the reliability of patients' self-reported medication use. Five hundred patients admitted to an acute medical depar...

    journal_title：Journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1177/0091270007307243

    authors： Glintborg B,Hillestrøm PR,Olsen LH,Dalhoff KP,Poulsen HE

    更新日期：2007-11-01 00:00:00

  • Pharmacokinetics and tolerability of intravenous trecovirsen (GEM 91), an antisense phosphorothioate oligonucleotide, in HIV-positive subjects.

    abstract：:Trecovirsen, a 25-mer antisense phosphorothioate oligonucleotide targeted at the gag site of the HIV gene, was administered to HIV-positive volunteers as an i.v. infusion. Single doses ranged from 0.1 to 2.5 mg/kg in an ascending escalation in cohorts of 6 to 12 subjects. Plasma trecovirsen concentrations and pharmaco...

    journal_title：Journal of clinical pharmacology

    pub_type： 临床试验,杂志文章

    doi：10.1177/00912709922007552

    authors： Séréni D,Tubiana R,Lascoux C,Katlama C,Taulera O,Bourque A,Cohen A,Dvorchik B,Martin RR,Tournerie C,Gouyette A,Schechter PJ

    更新日期：1999-01-01 00:00:00

  • Absence of QTc prolongation in a thorough QT study with subcutaneous liraglutide, a once-daily human GLP-1 analog for treatment of type 2 diabetes.

    abstract：:The objective of this study was to establish effects of liraglutide on the QTc interval. In this randomized, placebo-controlled, double-blind crossover study, 51 healthy participants were administered placebo, 0.6, 1.2, and 1.8 mg liraglutide once daily for 7 days each. Electrocardiograms were recorded periodically ov...

    journal_title：Journal of clinical pharmacology

    pub_type： 杂志文章,随机对照试验

    doi：10.1177/0091270009339189

    authors： Chatterjee DJ,Khutoryansky N,Zdravkovic M,Sprenger CR,Litwin JS

    更新日期：2009-11-01 00:00:00

  • Effect of renal impairment on the pharmacokinetics, pharmacodynamics, and safety of apixaban.

    abstract：:This open-label study evaluated apixaban pharmacokinetics, pharmacodynamics, and safety in subjects with mild, moderate, or severe renal impairment and in healthy subjects following a single 10-mg oral dose. The primary analysis determined the relationship between apixaban AUC∞ and 24-hour creatinine clearance (CLcr )...

    journal_title：Journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1002/jcph.633

    authors： Chang M,Yu Z,Shenker A,Wang J,Pursley J,Byon W,Boyd RA,LaCreta F,Frost CE

    更新日期：2016-05-01 00:00:00

  • Dosing Recommendations for Pediatric Patients With Renal Impairment.

    abstract：:A treatment gap exists for pediatric patients with renal impairment. Alterations in renal clearance and metabolism of drugs render standard dosage regimens inappropriate and may lead to drug toxicity, but these studies are not routinely conducted during drug development. The objective of this study was to examine the ...

    journal_title：Journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1002/jcph.1676

    authors： Al-Khouja A,Park K,Anderson DJC,Young C,Wang J,Huang SM,Khurana M,Burckart GJ

    更新日期：2020-12-01 00:00:00

  • Single-dose pharmacokinetics of repaglinide in subjects with chronic liver disease.

    abstract：:Repaglinide is a novel insulin secretagogue developed in response to the need for a fast-acting, oral prandial glucose regulator for the treatment of type 2 (non-insulin-dependent) diabetes mellitus. Repaglinide is metabolized mainly in the liver; its pharmacokinetics may therefore be altered by hepatic dysfunction. T...

    journal_title：Journal of clinical pharmacology

    pub_type： 临床试验,杂志文章

    doi：10.1177/00912700022008793

    authors： Hatorp V,Walther KH,Christensen MS,Haug-Pihale G

    更新日期：2000-02-01 00:00:00

  • Lack of significant effect of bilastine administered at therapeutic and supratherapeutic doses and concomitantly with ketoconazole on ventricular repolarization: results of a thorough QT study (TQTS) with QT-concentration analysis.

    abstract：:The effect of bilastine on cardiac repolarization was studied in 30 healthy participants during a multiple-dose, triple-dummy, crossover, thorough QT study that included 5 arms: placebo, active control (400 mg moxifloxacin), bilastine at therapeutic and supratherapeutic doses (20 mg and 100 mg once daily, respectively...

    journal_title：Journal of clinical pharmacology

    pub_type： 临床试验,杂志文章,随机对照试验

    doi：10.1177/0091270011407191

    authors： Tyl B,Kabbaj M,Azzam S,Sologuren A,Valiente R,Reinbolt E,Roupe K,Blanco N,Wheeler W

    更新日期：2012-06-01 00:00:00

  • Effect of hypothermia and sampling site on blood esmolol concentrations.

    abstract：:Esmolol hydrochloride was administered by constant-rate continuous infusion to 10 patients undergoing hypothermic cardiopulmonary bypass for coronary artery revascularization surgery. After a suitable loading dose, the esmolol infusion was started approximately 30 minutes before bypass and was stopped 10 minutes after...

    journal_title：Journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1002/j.1552-4604.1993.tb04670.x

    authors： Jacobs JR,Croughwell ND,Goodman DK,White WD,Reves JG

    更新日期：1993-04-01 00:00:00

  • Acetylator phenotype and genotype in HIV-infected patients with and without sulfonamide hypersensitivity.

    abstract：:Adverse reactions to sulfonamides occur at a higher frequency in patients infected with the human immunodeficiency virus (HIV) than noninfected patients. Some studies have suggested that patients with the slow acetylator phenotype are predisposed to these reactions, whereas other studies suggest that the slow acetylat...

    journal_title：Journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1177/00970002042006004

    authors： O'Neil WM,MacArthur RD,Farrough MJ,Doll MA,Fretland AJ,Hein DW,Crane LR,Svensson CK

    更新日期：2002-06-01 00:00:00

  • An open-label, parallel group study investigating the effects of age and gender on the pharmacokinetics of the once-daily glucagon-like peptide-1 analogue liraglutide.

    abstract：:Liraglutide is a once-daily glucagon-like peptide-1 analogue being developed for the treatment of type 2 diabetes. The aim of this study was to investigate the effect of age and gender on the pharmacokinetics of liraglutide. Eight male and 8 female subjects were recruited from an 18- to 45-year-old group and an over-6...

    journal_title：Journal of clinical pharmacology

    pub_type： 临床试验,杂志文章

    doi：10.1177/0091270006288215

    authors： Damholt B,Golor G,Wierich W,Pedersen P,Ekblom M,Zdravkovic M

    更新日期：2006-06-01 00:00:00

  • Darunavir/ritonavir pharmacokinetics following coadministration with clarithromycin in healthy volunteers.

    abstract：:This study investigated the steady-state pharmacokinetic interaction between the HIV protease inhibitor, darunavir (TMC114), administered with low-dose ritonavir (darunavir/ritonavir), and clarithromycin in HIV-negative healthy volunteers. In a 3-way crossover study, 18 individuals received darunavir/ritonavir 400/100...

    journal_title：Journal of clinical pharmacology

    pub_type： 杂志文章,随机对照试验

    doi：10.1177/0091270007309706

    authors： Sekar VJ,Spinosa-Guzman S,De Paepe E,De Pauw M,Vangeneugden T,Lefebvre E,Hoetelmans RM

    更新日期：2008-01-01 00:00:00

  • Which studies of therapy merit credence? Vitamin E and estrogen therapy as cautionary examples.

    abstract：:A vast and continuously growing amount of material on drugs exists in the literature to read and evaluate. Frequently, the papers and their recommendations are conflicting and contradictory. Readers are faced with the dilemma of deciding what to believe. The need for evidence-based medicine as a foundation for optimal...

    journal_title：Journal of clinical pharmacology

    pub_type： 杂志文章,评审

    doi：

    authors： Spector R,Vesell ES

    更新日期：2002-09-01 00:00:00

  • Lack of effect of cimetidine on the pharmacokinetics of sustained-release bupropion.

    abstract：:The objective of this study was to assess whether cimetidine affects the pharmacokinetics of sustained-release (SR) bupropion hydrochloride and the active metabolite, hydroxybupropion. This randomized, open-label, two-period crossover study was conducted in 24 healthy volunteers 18 to 45 years of age. ANOVA showed tha...

    journal_title：Journal of clinical pharmacology

    pub_type： 临床试验,杂志文章,随机对照试验

    doi：

    authors： Kustra R,Corrigan B,Dunn J,Duncan B,Hsyu PH

    更新日期：1999-11-01 00:00:00

  • The relevance of T-type calcium antagonists: a profile of mibefradil.

    abstract：:L- and T-type voltage-dependent transmembrane calcium channels are important for normal functioning of the cardiovascular system. T-type channels are a heterogeneous group, and have physiologic and pathophysiologic relevance in a number of organ systems, including the heart and central nervous system. They appear to b...

    journal_title：Journal of clinical pharmacology

    pub_type： 杂志文章,评审

    doi：10.1002/j.1552-4604.1998.tb04804.x

    authors： Glasser SP

    更新日期：1998-08-01 00:00:00

  • Rivaroxaban as an Alternative Agent for Heparin-Induced Thrombocytopenia.

    abstract：:Heparin-induced thrombocytopenia (HIT) is a high-risk adverse drug reaction because of its associated risk of life- and limb-threatening thrombosis. Rivaroxaban may be considered as an ideal nonheparin anticoagulant alternative for the management of HIT. In this preliminary retrospective study, the efficacy and safety...

    journal_title：Journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1002/jcph.1635

    authors： Farasatinasab M,Zarei B,Moghtadaei M,Nasiripour S,Ansarinejad N,Zarei M

    更新日期：2020-10-01 00:00:00

  • The Application of Physiologically Based Pharmacokinetic Modeling to Predict the Role of Drug Transporters: Scientific and Regulatory Perspectives.

    abstract：:Transporters play an important role in drug absorption, disposition, and drug action. The evaluation of drug transporters requires a comprehensive understanding of transporter biology and pharmacology. Physiologically based pharmacokinetic (PBPK) models may offer an integrative platform to quantitatively evaluate the ...

    journal_title：Journal of clinical pharmacology

    pub_type： 杂志文章,评审

    doi：10.1002/jcph.740

    authors： Pan Y,Hsu V,Grimstein M,Zhang L,Arya V,Sinha V,Grillo JA,Zhao P

    更新日期：2016-07-01 00:00:00

  • Specific and pronounced impacts of lisinopril and lisinopril plus simvastatin on erythrocyte antioxidant enzymes.

    abstract：:Angiotensin-converting enzyme inhibitors are effective at reducing blood pressure, whereas statins decrease plasma cholesterol impeding atherosclerosis. It is hypothesized that these medications may improve blood pressure and serum cholesterol by modifying the antioxidative status and energy metabolism of erythrocytes...

    journal_title：Journal of clinical pharmacology

    pub_type： 杂志文章,随机对照试验

    doi：10.1177/0091270009344854

    authors： Kaminsky Y,Suslikov A,Kosenko E

    更新日期：2010-02-01 00:00:00

  • The effect of lovastatin on early restenosis.

    abstract：:The effect of lovastatin given before percutaneous coronary angioplasty (PTCA) on early restenosis was investigated in men with mild to moderate hypercholesterolemia. Thirty-four hypercholesterolemic patients (serum LDL cholesterol 130-200 mg/dL) undergoing their first PTCA completed a 6-month prospective, double-blin...

    journal_title：Journal of clinical pharmacology

    pub_type： 临床试验,杂志文章,随机对照试验

    doi：10.1002/j.1552-4604.1995.tb05017.x

    authors： Beigel Y,Zafrir N,Teplitzky Y,Neuman Y,Gavish D,Wurzel M,Fainaru M

    更新日期：1995-06-01 00:00:00

  • Comparative effects of dopaminergic agonists on cardiovascular, renal, and renin-angiotensin systems in hypertensive patients.

    abstract：:The role of dopaminergic receptors on renal function has been extensively studied. Recently dopaminergic receptor has been classified in two subtypes D1 and D2, which seem to have different modulatory function. However, the role of dopaminergic receptors on cardiovascular function and more specifically the potential r...

    journal_title：Journal of clinical pharmacology

    pub_type： 临床试验,杂志文章

    doi：10.1002/j.1552-4604.1992.tb03788.x

    authors： Luchsinger A,Velasco M,Urbina A,Morillo J,Romero E,Alvarez R,Pieretti OH

    更新日期：1992-01-01 00:00:00

  • Pharmacokinetics, safety, and tolerability following multiple oral doses of varenicline under various titration schedules in elderly nonsmokers.

    abstract：:This study was designed to investigate the multiple-dose pharmacokinetics, safety, and tolerability of the selective α4β2 nicotinic acetylcholine partial agonist, varenicline, in elderly (65-85 years old) nonsmokers. Fifty male and female subjects with normal renal function for their age were randomized to receive var...

    journal_title：Journal of clinical pharmacology

    pub_type： 杂志文章,多中心研究,随机对照试验

    doi：10.1177/0091270010370461

    authors： Zhao Q,Schwam E,Fullerton T,O'Gorman M,Burstein AH

    更新日期：2011-04-01 00:00:00

  • Influence of Panax ginseng on cytochrome P450 (CYP)3A and P-glycoprotein (P-gp) activity in healthy participants.

    abstract：:A number of herbal preparations have been shown to interact with prescription medications secondary to modulation of cytochrome P450 (CYP) and/or P-glycoprotein (P-gp). The purpose of this study was to determine the influence of Panax ginseng on CYP3A and P-gp function using the probe substrates midazolam and fexofena...

    journal_title：Journal of clinical pharmacology

    pub_type： 临床试验,杂志文章

    doi：10.1177/0091270011407194

    authors： Malati CY,Robertson SM,Hunt JD,Chairez C,Alfaro RM,Kovacs JA,Penzak SR

    更新日期：2012-06-01 00:00:00