731 POSTER Open-label, single-dose, phase I study evaluating the mass balance and pharmacokinetics (PKs) of sunitinib (SU) in healthy male subjects

2007 ◽  
Vol 5 (4) ◽  
pp. 116 ◽  
Author(s):  
L. Sherman ◽  
G. Peng ◽  
S. Patyna ◽  
W. Pool ◽  
J. Smeraglia ◽  
...  
Keyword(s):  
Single Dose ◽  
Phase I ◽  
Mass Balance ◽  
Phase I Study ◽  
Healthy Male ◽  
Open Label ◽  
Male Subjects

A phase I, open-label, single-dose, mass balance study of 14C-labeled abiraterone acetate in healthy male subjects

Xenobiotica ◽  
2012 ◽  
Vol 43 (4) ◽  
pp. 379-389 ◽  
Author(s):  
Milin Acharya ◽  
Martha Gonzalez ◽  
Geert Mannens ◽  
Ronald De Vries ◽  
Christian Lopez ◽  
...  
Keyword(s):  
Single Dose ◽  
Phase I ◽  
Mass Balance ◽  
Abiraterone Acetate ◽  
Healthy Male ◽  
Open Label ◽  
Balance Study ◽  
Mass Balance Study ◽  
Male Subjects

A phase I study of the effect of repeated oral doses of pantoprazole on the pharmacokinetics of a single dose of fedratinib in healthy male subjects

2020 ◽  
Vol 85 (5) ◽  
pp. 995-1001 ◽  
Author(s):  
Ken Ogasawara ◽  
Bradley Vince ◽  
Christine Xu ◽  
Meng Zhang ◽  
Maria Palmisano ◽  
...  
Keyword(s):  
Single Dose ◽  
Phase I ◽  
Phase I Study ◽  
Healthy Male ◽  
Oral Doses ◽  
Male Subjects

An Open-Label, Single Ascending Dose Phase I Study of F-627, a G-CSF Dimer, In Healthy Male Subjects

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 4722-4722
Author(s):  
Xiao Qiang Yan ◽  
Peter G Hodsman ◽  
Zhi Hua Huang ◽  
Rou Yun Sun ◽  
Nai Chau Sun ◽  
...  
Keyword(s):  
Phase I ◽  
Phase I Study ◽  
Conflicts Of Interest ◽  
High Dose Chemotherapy ◽  
Primary Objective ◽  
Severe Neutropenia ◽  
High Dose ◽  
Healthy Male ◽  
Open Label ◽  
Male Subjects

Abstract Abstract 4722 The management of severe neutropenia in cancer patients after high-dose chemotherapy remains a challenge, although recombinant human G-CSFs including filgrastim, lengogratim and pegfilgrastim have been widely used. We developed F-627, a mammalian expressed recombinant human G-CSF dimer to treat severe neutropenia. In a cyclophosphamide-induced neutropenia monkey model, F-627 significantly reduced the duration and lessened the severity of neutropenia compared to monkeys treated with G-CSF or pegylated G-CSF. We report the phase I results of F-627 in healthy male subjects receiving ascending single dose at 30, 60, 120 and 240 ug/kg by subcutaneous injection. The primary objective of the phase I study was to assess the safety and tolerability of F-627. The secondary objective was to evaluate the pharmacokinetics and pharmacodynamics (PK/PD) responses. F-627 was well tolerated in healthy male volunteers. Dose-dependent PD responses including increased WBC, ANC and CD34 levels in peripheral blood were demonstrated. These results indicate that the mechanism of action of F-627 is similar to the monomer recombinant hG-CSFs, while the mode of action of F-627 is different with unique PK/PD properties in human. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Effect of renal function on the pharmacokinetics of fimasartan: a single-dose, open-label, Phase I study

2014 ◽  
pp. 1723 ◽  
Author(s):  
Seokuee Kim ◽  
Jongtae Lee ◽  
Donghoon Shin ◽  
Kyoung Soo Lim ◽  
Yon Su Kim ◽  
...  
Keyword(s):  
Renal Function ◽  
Single Dose ◽  
Phase I ◽  
Phase I Study ◽  
Open Label ◽  
Open Label Phase

scholarly journals Single-Dose Phase I Study To Evaluate the Pharmacokinetics of Posaconazole in New Tablet and Capsule Formulations Relative to Oral Suspension

2012 ◽  
Vol 56 (8) ◽  
pp. 4196-4201 ◽  
Author(s):  
Gopal Krishna ◽  
Lei Ma ◽  
Monika Martinho ◽  
Edward O'Mara
Keyword(s):  
Single Dose ◽  
Phase I ◽  
Coefficient Of Variation ◽  
Phase I Study ◽  
Area Under The Curve ◽  
Oral Suspension ◽  
High Fat ◽  
Open Label ◽  
Proven Efficacy ◽  
Fat Meal

ABSTRACTPosaconazole oral suspension, a marketed extended-spectrum triazole with proven efficacy as antifungal treatment and prophylaxis, should be taken with food to maximize absorption. New tablet and capsule formulations have been developed in an attempt to optimize absorption and bioavailability. The aims of this exploratory open-label, partially randomized, 2-part, 4-way, single-dose crossover study in 16 healthy adults were to characterize pharmacokinetics for posaconazole tablet and capsule formulations relative to those for posaconazole oral suspension under fasted and fed conditions and to assess safety and tolerability. Under fasted conditions, posaconazole exposures (area under the curve [AUC]) for the tablet and capsule formulations were similar (mean AUC from time zero to infinity [AUC0–∞], tablet A, 11,700 ng · h/ml [coefficient of variation {CV}, 26%]; tablet B, 11,300 ng · h/ml [CV, 22%]; capsule, 11,000 ng · h/ml [CV, 25%]) and were substantially higher than the exposure for the oral suspension (mean AUC0–∞, 3,420 ng · h/ml [CV, 44%]). Tablets and capsule showed less variability in exposure than the oral suspension. In fed subjects, tablets and capsule resulted in similar AUC values (mean AUC0–∞, tablet A, 11,900 ng · h/ml [23%]; tablet B, 12,400 ng · h/ml [CV, 25%]; capsule, 12,300 ng · h/ml [CV, 28%]) and slightly higher exposure than the oral suspension (mean AUC0–∞, 8,750 [CV, 24%]). Median times to the maximum concentration of drug in plasma were 4 to 5 h (fasted conditions) and 6 to 8 h (fed conditions). Mean half-lives values were similar for all formulations under fed and fasted conditions (23.1 to 29.2 h). Consistent with previous data, exposure for the oral suspension increased 2.5- to 3-fold when it was given with a high-fat meal. Conversely, exposures for tablets and capsule were not markedly affected by food. All formulations of posaconazole at 100 mg were safe and well tolerated.

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