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

Sponsored by Akebia Therapeutics

About this trial

Last updated 6 years ago

Study ID

AKB-6548-CI-0024

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
18 to 70 Years
All
All

Trial Timing

Ended 7 years ago

What is this trial about?

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.

What are the Participation Requirements?

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