Status:
COMPLETED
A Single Dose Study of Oral Vadadustat in Subjects With Normal and Impaired Hepatic Function
Lead Sponsor:
Akebia Therapeutics
Conditions:
Hepatic Impairment
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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...
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 re...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03799848
Start Date
June 12 2018
End Date
October 18 2018
Last Update
March 22 2019
Active Locations (2)
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1
Prism Clinical Research
Saint Paul, Minnesota, United States, 55114
2
American Research Corporation at the University of Texas Liver Institute
San Antonio, Texas, United States, 78215