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

NCT03799848 | Completed Phase 1 FDA Drug

• 1 other identifier: AKB-6548-CI-0024
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatic Impairment

Keywords

Hepatic impairment; Healthy subjects; Child-pugh; Vadadustat

Outcome Measures

Primary Outcomes (3)

• Area under the concentration-time curve from dosing to last measurable concentration (AUClast)

  Day 1, Day 4

• Area under the concentration-time curve from dosing to infinity (AUCinf)

  Day 1, Day 4

• Observed maximum concentration (Cmax).

  Day 1, Day 4

Secondary Outcomes (18)

• Time to reach Cmax of vadadustat

  Day 1, Day 4

• Apparent total body clearance (CL/F) of vadadustat

  Day 1, Day 4

• Apparent volume of distribution (Vd/F) of vadadustat

  Day 1, Day 4

• Terminal half-life (t1/2) of vadadustat

  Day 1, Day 4

• Time to reach Tmax of vadadustat

  Day 1, Day 4

Study Arms (1)

Vadadustat

EXPERIMENTAL

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)

Drug: Vadadustat

Interventions

Vadadustat DRUG

Oral tablet

Also known as: AKB-6548

Vadadustat

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Akebia Therapeutics: lead

Study Sites (2)

Prism Clinical Research

Saint Paul, Minnesota, 55114, United States

Location

American Research Corporation at the University of Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Interventions

vadadustat

Study Officials

• Akebia Therapeutics

  Akebia Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: January 10, 2019
• Study Start: June 12, 2018
• Primary Completion: October 18, 2018
• Study Completion: October 18, 2018
• Last Updated: March 22, 2019

Record last verified: 2019-03

Locations

US (2)