Anti-IL21 receptor monoclonal antibody (ATR-107): Safety, pharmacokinetics, and pharmacodynamic evaluation in healthy volunteers: a phase I, first-in-human study.

abstract：:Antibody-drug conjugates (ADCs) represent an innovative therapeutic approach that provides novel treatment options and hope for patients with cancer. By coupling monoclonal antibodies (mAbs) to cytotoxic small-molecule payloads with a plasma-stable linker, ADCs offer the potential for increased drug specificity and fe...

journal_title：Journal of clinical pharmacology

authors： Vezina HE,Cotreau M,Han TH,Gupta M

更新日期：2017-10-01 00:00:00

abstract：:Golimumab is a fully human antitumor necrosis factor alpha (TNF-alpha) monoclonal antibody that is being developed for intravenous and subcutaneous administration. To assess the pharmacokinetics and safety of the intravenous formulation of golimumab, 36 adult subjects with rheumatoid arthritis were randomly assigned t...

journal_title：Journal of clinical pharmacology

authors： Zhou H,Jang H,Fleischmann RM,Bouman-Thio E,Xu Z,Marini JC,Pendley C,Jiao Q,Shankar G,Marciniak SJ,Cohen SB,Rahman MU,Baker D,Mascelli MA,Davis HM,Everitt DE

更新日期：2007-03-01 00:00:00

abstract：:Clinical pharmacology of L-asparaginase was compared by intramuscular and intravenous injections in 12 patients with metastatic cancer or leukemia. Following a single intramuscular injection at the gluteal site of L-asparaginase (10,000 IU/m2), the enzyme appeared in plasma as measured initially at 1 hour, but plateau...

journal_title：Journal of clinical pharmacology

authors： Ho DH,Yap HY,Brown N,Benjamin RS,Friereich EJ,Blumenschein GR,Bodey GP

更新日期：1981-02-01 00:00:00

abstract：:The analgesic activity of buprenorphine was monitored versus that of morphine in a double-blind, randomized, multiple-dose, parallel-design study involving 97 postsurgical patients. Patients could receive intramuscular injections of either buprenorphine (0.3, o.45, or 0.6 mg) or morphine (10, 15, or 20 mg) every 3 or ...

journal_title：Journal of clinical pharmacology

authors： Ouellette RD

更新日期：1982-04-01 00:00:00

abstract：:Due to the prevalence of both gastrointestinal and cardiovascular diseases, it is likely that patients may be coprescribed gastric parietal cell proton pump inhibitors and beta-adrenergic antagonists. Therefore, the objectives of this phase I study were to assess the potential effects of the coadministration of lansop...

journal_title：Journal of clinical pharmacology

authors： Karol MD,Locke CS,Cavanaugh JH

更新日期：2000-03-01 00:00:00

abstract：:To investigate whether methyldopa alters digoxin disposition, eight healthy subjects received methyldopa titrated to 250 mg t.i.d. or placebo in a double-blind, cross-over manner for 16 consecutive days, with 0.25 mg intravenous digoxin coadministered on day 5 and 0.25 mg oral digoxin on days 9 to 16. Digoxin concentr...

journal_title：Journal of clinical pharmacology

authors： May CA,Vlasses PH,Rocci ML Jr,Rotmensch HH,Swanson BN,Tannenbaum RP,Ferguson RK,Abrams WB

更新日期：1984-08-01 00:00:00

abstract：:Cannabichromene (CBC) is one of four major cannabinoids in Cannabis sativa L. and is the second most abundant cannabinoid in drug-type cannabis. Cannabichromene and some of its homologs, analogs, and isomers were evaluated for antiinflammatory, antibacterial, and antifungal activity. Antiinflammatory activity was eval...

journal_title：Journal of clinical pharmacology

authors： Turner CE,Elsohly MA

更新日期：1981-08-01 00:00:00

abstract：:Controlled-onset extended-release verapamil (COER-V) is designed so drug concentrations rise sharply in the early morning to coincide with the peak incidence of cardiovascular events. The primary objective of this study was to compare the diurnal pattern of forearm vascular resistance (FVR) between hypertensives and n...

journal_title：Journal of clinical pharmacology

authors： Nguyen BN,Parker RB,Noujedehi M,Sullivan JM,Johnson JA

更新日期：2000-12-01 00:00:00

abstract：:The need for clinical pharmacology in research and education, drug development, and health care delivery is well known. However, a current profile of those working in the field is not available. The ACCP authorized a survey of clinical pharmacologists to provide such a profile. Members of the ACCP or ASCPT were solici...

journal_title：Journal of clinical pharmacology

authors： Wilson JT,Brown RD,Kimura KK,Whelton A

更新日期：1989-08-01 00:00:00

abstract：:The absolute bioavailability of oral melatonin tablets was studied in 12 normal healthy volunteers. Subjects were administered, in a randomized crossover fashion, melatonin 2 mg intravenously and 2 and 4 mg orally. Blood was sampled over approximately eight (estimated) half-lives. Both the 2 and the 4 mg oral dosages ...

journal_title：Journal of clinical pharmacology

authors： DeMuro RL,Nafziger AN,Blask DE,Menhinick AM,Bertino JS Jr

更新日期：2000-07-01 00:00:00

abstract：:Nineteenth century ophthalmology, characterized by significant gains in diagnostic techniques, provided the basis for great advancements in treatment during the 20th century. Drug therapy at the turn of the century was empiric, palliative, and often toxic. The development of ocular pharmacology during the 20th century...

journal_title：Journal of clinical pharmacology

authors： Williams PB,Crouch ER Jr,Sheppard JD Jr,Lattanzio FA Jr,Parker TA,Mitrev PV

更新日期：2000-09-01 00:00:00

abstract：:Although glucocorticoids and cyclosporine are frequently used to treat patients with various types of glomerulopathy, clinical responses to treatment vary considerably. Considerable interindividual heterogeneity in the suppressive effects of glucocorticoids on lymphocyte proliferation in vitro has been previously repo...

journal_title：Journal of clinical pharmacology

authors： Briggs WA,Gao ZH,Xing JJ,Gimenez LF,Samaniego MD,Scheel PJ,Choi MJ,Burdick JF

更新日期：1996-10-01 00:00:00

abstract：:Sixteen healthy male volunteers received a single oral dose of 25 mg doxylamine succinate. Doxylamine concentrations in plasma were measured by a newly developed gas chromatographic methodology, utilizing direct alkaline extraction into hexane:isoamyl alcohol followed by concentration and autoinjection. Doxylamine kin...

journal_title：Journal of clinical pharmacology

authors： Friedman H,Greenblatt DJ

更新日期：1985-09-01 00:00:00

abstract：:A bioequivalence study of two oral formulations of 300 mg ranitidine was carried out in 16 healthy volunteers (8 men and 8 women), and the pharmacokinetics in both sexes were compared. There was bioequivalence of both formulations. The terminal half-life of ranitidine was 7% shorter and the oral apparent clearance 10....

journal_title：Journal of clinical pharmacology

authors： Abad-Santos F,Carcas AJ,Guerra P,Govantes C,Montuenga C,Gómez E,Fernández A,Frias J

更新日期：1996-08-01 00:00:00

abstract：:Research into the distribution of medication errors usually focuses on isolated stages within the medication use process. Our study aimed to provide a novel process-oriented approach to medication incident analysis focusing on medication error chains. Our study was conducted across a 900-bed teaching hospital in Switz...

journal_title：Journal of clinical pharmacology

authors： Huckels-Baumgart S,Manser T

更新日期：2014-10-01 00:00:00

abstract：:Ceftaroline, the active form of ceftaroline fosamil, is a broad-spectrum cephalosporin antibiotic. A population pharmacokinetic (PPK) model for ceftaroline was developed in NONMEM® using data from 185 healthy subjects and 92 patients with acute bacterial skin and skin structure infection (ABSSSI). Data from 128 patien...

journal_title：Journal of clinical pharmacology

authors： Van Wart SA,Forrest A,Khariton T,Rubino CM,Bhavnani SM,Reynolds DK,Riccobene T,Ambrose PG

更新日期：2013-11-01 00:00:00

abstract：:A total of 175 physicians were surveyed by questionnaire before a Clinical Pharmacology Consult Service was started. Of those that responded, 72% thought the service would be helpful, although 40% said they would use the service no more than once a month. Most physicians (75%) preferred self-initiated consultations to...

journal_title：Journal of clinical pharmacology

authors： Casner PR,Dillon KR

更新日期：1988-01-01 00:00:00

abstract：:CGS 13080, a selective thromboxane synthetase inhibitor, was given intravenously (0.6 mg/kg over 6 hours) to eight hypertensive (diastolic 95-115 mm Hg) euvolemic caucasian females on their customary salt intake (24 hour urine Na: 142.9 +/- 14.8 meq). No change occurred in blood pressure or glomerular filtration rate ...

journal_title：Journal of clinical pharmacology

authors： Weir MR,Klassen DK,Hoover N,Douglas FL

更新日期：1989-12-01 00:00:00

abstract：:Acute asthma exacerbations are primarily due to airway inflammation and remain one of the most frequent reasons for childhood hospitalizations. Although systemic corticosteroids remain the mainstay of therapy because of their anti-inflammatory properties, not all inflammatory pathways are responsive to systemic cortic...

journal_title：Journal of clinical pharmacology

authors： Arnold DH,Van Driest SL,Reiss TF,King JC,Akers WS

更新日期：2021-03-01 00:00:00

abstract：:Following oral administration of a single 500-mg dose of cefalexin, serum and urine levels of the antibiotic were determined comparatively in ten normal subjects, ten patients with renal impairment, and ten patients with chronic nephritis on maintenance hemodialysis. In normal subjects, mean serum peak levels (12.0 +/...

journal_title：Journal of clinical pharmacology

authors： Brogard JM,Pinget M,Dorner M,Lavillaureix J

更新日期：1975-10-01 00:00:00

abstract：:Nilotinib, an oral inhibitor of the tyrosine kinase activity of Abelson protein, is approved for the treatment of patients with newly diagnosed chronic myeloid leukemia (CML) in chronic phase and patients with CML in chronic phase or accelerated phase resistant or intolerant to prior therapies. This review describes t...

journal_title：Journal of clinical pharmacology

authors： Tian X,Zhang H,Heimbach T,He H,Buchbinder A,Aghoghovbia M,Hourcade-Potelleret F

更新日期：2018-12-01 00:00:00

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

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

abstract：:MC4-NN2-0453 is a novel, long-acting, selective, melanocortin-4-receptor agonist developed for treatment of obesity. This first-human-dose, randomized, double-blind, placebo-controlled trial investigated the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of MC4-NN2-0453 in ov...

journal_title：Journal of clinical pharmacology

authors： Royalty JE,Konradsen G,Eskerod O,Wulff BS,Hansen BS

更新日期：2014-04-01 00:00:00

abstract：:In the pivotal TEMPO 3:4 trial, the arginine vasopressin V2-receptor antagonist tolvaptan reduced the rate of kidney growth in patients with autosomal dominant polycystic kidney disease. Tolvaptan was initiated as daily morning/afternoon doses of 45/15 mg, and uptitrated weekly to 60/30 mg and 90/30 mg according to pa...

journal_title：Journal of clinical pharmacology

authors： Shoaf SE,Chapman AB,Torres VE,Ouyang J,Czerwiec FS

更新日期：2017-07-01 00:00:00

abstract：:The rate of change of plasma procainamide concentration during 36 hours of constant-rate intravenous infusion was examined in five acute myocardial infarction patients. It was observed that a steady-state plasma concentration was established in about 16 hours, which is consistent with simulations of plasma concentrati...

journal_title：Journal of clinical pharmacology

authors： Lalka D,Wyman MG,Goldreyer BN,Ludden TM,Cannom DS

更新日期：1978-08-01 00:00:00

abstract：:Eleven subjects completed a clinical trial to determine the safety/tolerability of freeze-dried black raspberries (BRB) and to measure, in plasma and urine, specific anthocyanins-cyanidin-3-glucoside, cyanidin-3-sambubioside, cyanidin-3-rutinoside, and cyanidin-3-xylosylrutinoside, as well as ellagic acid. Subjects we...

journal_title：Journal of clinical pharmacology

authors： Stoner GD,Sardo C,Apseloff G,Mullet D,Wargo W,Pound V,Singh A,Sanders J,Aziz R,Casto B,Sun X

更新日期：2005-10-01 00:00:00

abstract：:Understanding how inhibition of cytochrome P4503A (CYP3A) affects the metabolism of a new drug is critical in determining if a clinically relevant drug interaction will occur. Diltiazem interaction studies assess a given compound's sensitivity to moderate CYP3A inhibition. The present study compared the effect differe...

journal_title：Journal of clinical pharmacology

authors： Friedman EJ,Fraser IP,Wang YH,Bergman AJ,Li CC,Larson PJ,Chodakewitz J,Wagner JA,Stoch SA

更新日期：2011-11-01 00:00:00

abstract：:Varenicline is a novel selective α4β2 nicotinic acetylcholine partial agonist developed for smoking cessation. Single- and multiple dose studies were conducted to investigate pharmacokinetics, safety, and tolerability of varenicline in healthy male Japanese smokers. The single-dose study was conducted as a double-blin...

journal_title：Journal of clinical pharmacology

authors： Kikkawa H,Maruyama N,Fujimoto Y,Hasunuma T

更新日期：2011-04-01 00:00:00

abstract：:The inhibitory effects of isoflavones (daidzein, genistein, and glycitein) on human cytochrome P450 (CYP) 2A6 activities were investigated. Daidzein, genistein, and glycitein uncompetitively inhibited nicotine C-oxidation catalyzed by recombinant CYP2A6 expressed in baculovirus-infected insect cells with Ki values of ...

journal_title：Journal of clinical pharmacology

authors： Nakajima M,Itoh M,Yamanaka H,Fukami T,Tokudome S,Yamamoto Y,Yamamoto H,Yokoi T

更新日期：2006-03-01 00:00:00

abstract：:Many astronauts experience intolerance to orthostatic stress after space flight, despite the ingestion of salt tablets and water equivalent to 0.9% saline just before their return to Earth. Previous research indicates that the ingestion of 1.07% saline solution increased plasma volume more than did 0.9% saline. Theref...

journal_title：Journal of clinical pharmacology

authors： Frey MA,Lathers C,Davis J,Fortney S,Charles JB

更新日期：1994-05-01 00:00:00