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

NCT ID: NCT03799848

Last Updated: 2019-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-12
• Study Completion Date: 2018-10-18

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.

Conditions

Hepatic Impairment

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Vadadustat

Group 1: Subjects with moderately impaired hepatic function (Child-Pugh Class B) Group 2: Normal healthy volunteers Group 3: Subjects with mildly impaired hepatic function (Child-Pugh Class A)

Group Type: EXPERIMENTAL

Vadadustat

Intervention Type: DRUG

Oral tablet

Interventions

Vadadustat

Oral tablet

Intervention Type: DRUG

Other Intervention Names

AKB-6548

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Akebia Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Akebia Therapeutics

Role: STUDY_DIRECTOR

Akebia Therapeutics

Locations

Prism Clinical Research

Saint Paul, Minnesota, United States

American Research Corporation at the University of Texas Liver Institute

San Antonio, Texas, United States

Countries

United States

Other Identifiers

AKB-6548-CI-0024

Identifier Type: -

Identifier Source: org_study_id