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

NCT ID: NCT02161224

Last Updated: 2014-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2013-12-31

Brief Summary

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.

Detailed Description

The effect of moderate hepatic impairment on the pharmacokinetics (PK), safety and tolerability of a single dose of FG-4592 in male and female subjects is investigated. Data obtained from these subjects are compared to data from BMI-, age- and sex-matched subjects with normal hepatic function. Both groups consist of 8 subjects.

Screening takes place from Days -22 to -2 before admission to the clinical unit on Day -1. Administration of the trial medication takes place on Day 1 under fasted conditions. Healthy subjects are discharged on Day 5 and subjects with moderate hepatic impairment on Day 7, if there is no reason to extend the stay. An end-of-study visit (ESV) takes place 5 to 9 days after (early) discharge.

Safety assessments are performed throughout the study.

Conditions

PK of FG-4592; Hepatic Insufficiency; Healthy Subjects

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

1: FG-4592 in subjects with moderate hepatic impairment

Group Type: EXPERIMENTAL

FG-4592

Intervention Type: DRUG

Oral

2: FG-4592 in healthy subjects

Group Type: EXPERIMENTAL

FG-4592

Intervention Type: DRUG

Oral

Interventions

FG-4592

Oral

Intervention Type: DRUG

Other Intervention Names

ASP1517,; roxadustat

Eligibility 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.

• 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.

• 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].

• Subject had a previous liver transplantation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

FibroGen

INDUSTRY

Sponsor Role: collaborator

Astellas Pharma Europe B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Central contact

Role: STUDY_DIRECTOR

Astellas Pharma Europe B.V.

Locations

COMAC

Sofia, , Bulgaria

Countries

Bulgaria

Other Identifiers

2013-001533-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1517-CL-0513

Identifier Type: -

Identifier Source: org_study_id