Healthy Subjects Clinical Trial
Official title:
A Phase 1, Non-randomized, Open-label, Single-dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of FG-4592 in Subjects With Moderate Hepatic Impairment and Healthy Subjects With Normal Hepatic Function
Verified date | June 2014 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | Bulgaria: Bulgarian Drug Agency |
Study type | Interventional |
The effect of moderately diminished liver function on the exposure, safety and tolerability of a single dose of FG-4592 is studied in male and female subjects. The results are compared to the data gained from subjects with normal liver function.
Status | Completed |
Enrollment | 16 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: Both healthy subjects and subjects with moderate hepatic impairment: - Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject prior to any study-related procedures (including withdrawal of prohibited medication, if applicable). - Male subjects and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and continuing throughout the study period and for 90 days after the study drug administration. In addition, subjects with moderate hepatic impairment must also meet the following inclusion criteria: - Subject has Child-Pugh classification Class B (moderate, 7 to 9 points) liver function impairment [screening]. Exclusion Criteria: Both healthy subjects and subjects with moderate hepatic impairment: - Female subject who has been pregnant within 6 months prior to screening or breastfeeding within 3 months before screening. - Subject has a known or suspected hypersensitivity to FG-4592, or any components of the formulation used. In addition, healthy subjects must also NOT meet the following exclusion criteria: - Subject has any of the liver function tests (LFT) (Aspartate Aminotransferase [AST], Alanine Aminotransferase [ALT], Alkaline Phosphatase [ALP], Gamma Glutamyl Transferase [GGT], Total Bilirubin [TBL] above the upper limit of normal (ULN). In such a case the assessment may be repeated once [Day-1]. In addition, subjects with moderate hepatic impairment must also NOT meet the following exclusion criteria: - Subject had a previous liver transplantation. |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Bulgaria | COMAC | Sofia |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Europe B.V. | FibroGen |
Bulgaria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetic parameter of FG-4592 in plasma as measured by area under the concentration-time curve (AUC) extrapolated to infinity (AUCinf) | Days 1 to 5 (Day 7 for hepatic impaired subjects) | No | |
Primary | Pharmacokinetic parameter of FG-4592 in plasma as measured by maximum concentration (Cmax) | Days 1 to 5 (Day 7 for hepatic impaired subjects) | No | |
Secondary | Pharmacokinetic profile of FG-4592 in plasma | AUC up to last quantifiable concentration (AUClast), AUC from 0 up to last quantifiable concentration based on unbound plasma concentration (AUClast,u), AUC from time point 0 to time point 24 hours (AUC0-24h), AUC from time point 0 to time point 24 hours based on unbound plasma concentration (AUC0-24h,u), unbound AUC extrapolated to infinity (AUCinf,u), unbound maximum concentration (observed) (Cmax,u), apparent total systemic clearance after extra-vascular dosing (CL/F), plasma clearance over bioavailability ratio based on unbound plasma (CLu/F), fraction unbound (fu), lag-time (time delay between drug administration and first observed concentration above the Limit of Quantification (LOQ) in plasma) (tlag), time to attain Cmax (tmax), apparent terminal elimination half-life (t1/2), apparent volume of distribution during terminal phase after oral administration (Vz/F), unbound apparent volume of distribution during terminal phase after oral administration (Vz,u/F) | Days 1 to 5 (Day 7 for hepatic impaired subjects) | No |
Secondary | Pharmacokinetic profile of FG-4592 in urine | renal clearance (CLR), renal clearance based on unbound concentration (CLR,u), renal clearance from time point 0 to 24 hours (CLR,0-24h), renal clearance from time point 0 to 24 hours based on unbound concentration (CLR,u 0-24h), amount of unchanged drug excreted into urine from time point 0 to infinity (Aeinf), amount of unchanged drug excreted into urine from time point 0 to infinity, percentage of dose (Aeinf%), amount of unchanged drug excreted into urine until the last observation time point (Aelast), amount of unchanged drug excreted into urine until the last observation time, percentage of dose (Aelast%), amount of drug excreted into urine from time point 0 to time point 24 hours (Ae0-24h), amount of drug excreted into urine from time point 0 to time point 24 hours, percentage of dose (Ae0-24h%) | Days 1 to 5 (Day 7 for hepatic impaired subjects) | No |
Secondary | Erythropoietin in plasma | maximum achievable pharmacologic effect (Emax), area under the concentration-time curve from 0 up to last quantifiable concentration based on EPO concentration (AUCE,last), tmax | Days 1 to 5 (Day 7 for hepatic impaired subjects) | No |
Secondary | Safety and tolerability of FG-4592 | Nature, frequency and severity of adverse events (AEs), vital signs, safety laboratory tests, electrocardiogram | Screening (Days -22 to -2) to ESV (5 to 9 days after (early) discharge) | No |
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