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
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 7 years ago
What is this trial about?
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