ClinicalTrials.Veeva

Menu

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

Akebia Therapeutics logo

Akebia Therapeutics

Status and phase

Completed
Phase 1

Conditions

Hepatic Impairment

Treatments

Drug: Vadadustat

Study type

Interventional

Funder types

Industry

Identifiers

NCT03799848
AKB-6548-CI-0024

Details and patient eligibility

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

24 participants in 1 patient group

Vadadustat
Experimental group
Description:
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)
Treatment:
Drug: Vadadustat

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems