A Study to Investigate the Exposure and Safety and Tolerability of a Single Dose of FG-4592 in Subjects With Moderately Diminished Liver Function Compared to Those With Normal Liver Function

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02161224
• Date of registration: 09/06/2014
• Prospective Registration: No
• Primary sponsor: Astellas Pharma Europe B.V.
• Public title: A Study to Investigate the Exposure and Safety and Tolerability of a Single Dose of FG-4592 in Subjects With Moderately Diminished Liver Function Compared to Those With Normal Liver Function
• Scientific 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
• Date of first enrolment: September 2013
• Target sample size: 16
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02161224
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: Phase 1

Countries of recruitment

Bulgaria

Contacts

• Name: Central contact
• Affiliation: Astellas Pharma Europe B.V.

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatic Insufficiency

PK of FG-4592

Healthy Subjects

Intervention(s)

Drug: FG-4592

Primary Outcome(s)

Pharmacokinetic parameter of FG-4592 in plasma as measured by maximum concentration (Cmax) [Time Frame: Days 1 to 5 (Day 7 for hepatic impaired subjects)]

Pharmacokinetic parameter of FG-4592 in plasma as measured by area under the concentration-time curve (AUC) extrapolated to infinity (AUCinf) [Time Frame: Days 1 to 5 (Day 7 for hepatic impaired subjects)]

Secondary Outcome(s)

Pharmacokinetic profile of FG-4592 in urine [Time Frame: Days 1 to 5 (Day 7 for hepatic impaired subjects)]

Safety and tolerability of FG-4592 [Time Frame: Screening (Days -22 to -2) to ESV (5 to 9 days after (early) discharge)]

Erythropoietin in plasma [Time Frame: Days 1 to 5 (Day 7 for hepatic impaired subjects)]

Pharmacokinetic profile of FG-4592 in plasma [Time Frame: Days 1 to 5 (Day 7 for hepatic impaired subjects)]

Secondary ID(s)

1517-CL-0513

2013-001533-41

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

FibroGen