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

• Status: Completed
• Trial end date: 2018-10-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Akebia Therapeutics

Criteria

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