NCT02161224

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
Last Updated

June 11, 2014

Status Verified

June 1, 2014

Enrollment Period

3 months

First QC Date

June 9, 2014

Last Update Submit

June 9, 2014

Conditions

PK of FG-4592Hepatic InsufficiencyHealthy Subjects

Keywords

Phase 1FG-4592Single doseModerate hepatic impairment

Outcome Measures

Primary Outcomes (2)

  • 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)

  • Pharmacokinetic parameter of FG-4592 in plasma as measured by maximum concentration (Cmax)

    Days 1 to 5 (Day 7 for hepatic impaired subjects)

Secondary Outcomes (4)

  • Pharmacokinetic profile of FG-4592 in plasma

    Days 1 to 5 (Day 7 for hepatic impaired subjects)

  • Pharmacokinetic profile of FG-4592 in urine

    Days 1 to 5 (Day 7 for hepatic impaired subjects)

  • Erythropoietin in plasma

    Days 1 to 5 (Day 7 for hepatic impaired subjects)

  • Safety and tolerability of FG-4592

    Screening (Days -22 to -2) to ESV (5 to 9 days after (early) discharge)

Study Arms (2)

1: FG-4592 in subjects with moderate hepatic impairment

EXPERIMENTAL
Drug: FG-4592

2: FG-4592 in healthy subjects

EXPERIMENTAL
Drug: FG-4592

Interventions

FG-4592DRUG

Oral

Also known as: ASP1517,, roxadustat
1: FG-4592 in subjects with moderate hepatic impairment2: FG-4592 in healthy subjects

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 \[screening\].

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

COMAC

Sofia, Bulgaria

Location

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

roxadustat

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Central contact

    Astellas Pharma Europe B.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2014

First Posted

June 11, 2014

Study Start

September 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 11, 2014

Record last verified: 2014-06

Locations

BU(1)