A Single Dose Study of Oral Vadadustat in Subjects With Normal and Impaired Hepatic Function

Phase 1, Open-Label, Parallel-Group, Pharmacokinetic Single Dose Study of Oral Vadadustat in Subjects With Normal and Impaired Hepatic Function

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03799848

Enrollment

Registered

2019-01-10

Start date

2018-06-12

Completion date

2018-10-18

Last updated

2019-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Impairment

Keywords

Hepatic impairment, Healthy subjects, Child-pugh, Vadadustat

Brief summary

This is a Phase I open-label study to evaluate the pharmacokinetic (PK) profile of a single oral dose of vadadustat in subjects with hepatic impairment(HI) compared to healthy matched control subjects with normal hepatic function.

Detailed description

This is an open label, parallel-group, single dose, Phase 1 study to evaluate the PK profile, safety, and tolerability of a single oral 450 mg dose of vadadustat in subjects with hepatic impairment relative to control subjects with normal hepatic function. The study will enroll up to 24 subjects in 3 groups of 8 subjects at 2 study sites. Blood samples for vadadustat PK and its metabolites will be collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 60, and 72 hours post-dose.

Interventions

DRUGVadadustat

Oral tablet

Study design

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

(All groups): * Male or female subjects between ≥18 years and ≤70 years of age * Have a body weight ≥45 kg and body mass index (BMI) ≥18.5 kg/m2 to 40.0 kg/m2 Additional Group-Specific Inclusion Criteria: * Group 1 (Moderate Hepatic Impairment Subjects): * Presence of Moderate hepatic impairment (Child-Pugh Class B) * Group 2 (Normal Hepatic Function Subjects): * Normal hepatic function * Group 3 (Mild Hepatic Impairment Subjects): * Presence of mild hepatic impairment ( Child-Pugh Class A)

Exclusion criteria

(all groups): * Renal impairment ≥ Stage 3 (estimated glomerular filtration rate \[eGFR\] \<60 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) study equation) * Any history of active malignancy within 2 years prior to or during screening, except for treated basal cell carcinoma of skin, curatively resected squamous cell carcinoma of skin, or cervical carcinoma in situ; any history of tuberculosis and/or prophylaxis for tuberculosis * Positive test for human immunodeficiency virus (HIV) antibody at Screening. * Hepatic or other organ or cell transplant * Subjects with alcoholic cirrhosis must be sober for a minimum of 6 months

Design outcomes

Primary

Measure	Time frame
Area under the concentration-time curve from dosing to last measurable concentration (AUClast)	Day 1, Day 4
Area under the concentration-time curve from dosing to infinity (AUCinf)	Day 1, Day 4
Observed maximum concentration (Cmax).	Day 1, Day 4

Secondary

Measure	Time frame
Terminal half-life (t1/2) of vadadustat	Day 1, Day 4
Time to reach Tmax of vadadustat	Day 1, Day 4
Assessment of Treatment-Emergent Adverse Events (TEAEs) as reported by study subjects	Up to 9 Weeks
Cmax related to free drug (Cmax, free) of Vadadustat Unbound	Day 1, Day 4
AUClast related to free drug (AUClast, free) of Vadadustat Unbound	Day 1, Day 4
AUCinf related to free drug (AUCinf, free) of Vadadustat Unbound	Day 1, Day 4
CL/F related to free drug (CL/Ffree) of Vadadustat Unbound	Day 1, Day 4
Time to reach Cmax of vadadustat	Day 1, Day 4
The area under the concentration-time curve from dosing to last measurable concentration (AUClast) of Vadadustat metabolites	Day 1, Day 4
The area under the concentration-time curve from dosing to infinity (AUCinf) of Vadadustat metabolite	Day 1, Day 4
Time to reach Cmax of vadadustat metabolites	Day 1, Day 4
Terminal half-life (t1/2) of Vadadustat metabolites	Day 1, Day 4
Renal clearance (CLr) of Vadadustat/metabolite(s) Urine	Day 1, Day 4
Cumulative amount of drug excreted (Ae) of Vadadustat/metabolite(s) Urine	Day 1, Day 4
Cumulative fraction of drug excreted (Fe) of Vadadustat/metabolite(s) Urine	Day 1, Day 4
Terminal half-life (t1/2) of Vadadustat Unbound	Day 1, Day 4
Apparent total body clearance (CL/F) of vadadustat	Day 1, Day 4
Apparent volume of distribution (Vd/F) of vadadustat	Day 1, Day 4

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026