Drug-Drug Interaction Study of Vadadustat With Digoxin, Adefovir and Furosemide

Drug Interaction Potentiation Clinical Trial

Official title:

A Phase 1 Open-label, Three Arm Study in Healthy Adult Volunteers to Assess Vadadustat as a Perpetrator in Drug-Drug-Interactions With Digoxin, Adefovir and Furosemide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03801759
• Other study ID #: AKB-6548-CI-0031
• Status: Completed
• Phase: Phase 1
• Start date: July 20, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: March 2019
• Source: Akebia Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1, open-label, 3-arm, fixed sequence, study to evaluate vadadustat as a perpetrator of drug-drug interactions (DDIs) with digoxin, adefovir and furosemide in healthy male and female subjects.

Description:

This is a Phase 1, open-label, 3-arm, fixed sequence, study to evaluate vadadustat as a perpetrator of drug-drug interactions (DDIs) with digoxin, adefovir and furosemide in healthy male and female subjects. Unique subjects will be enrolled into each arm of the study and enrollment will be sequential. The first 20 subjects confirmed to be eligible will be assigned to Arm 1 (digoxin), the next 16 subjects will be assigned to Arm 2 (adefovir) and the next 22 subjects will be assigned to Arm 3 (furosemide). Blood samples for PK analysis will be collected at pre-defined timepoints for each arm throughout the study. Subjects will be on study for up to 80 days, including a 28-day screening period, 7-21 day in clinic period, and a 30-day follow up period post last dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy Male or female between 18 and 55 years of age, inclusive, at time of informed consent.

• Body mass index between 18.0 and 30.0 kg/m2, with a minimum body weight of 45 kg for females and 50 kg for males, inclusive.

Exclusion Criteria:

• Current or past clinically significant history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease. History of cancer (except treated non-melanoma skin cancer) or history of chemotherapy use within 5 years prior to Screening.

• Positive test results for human immunodeficiency virus (HIV) antibody; Positive test results of hepatitis B surface antigen (HBsAg), or positive hepatitis C virus antibody (HCVab) within 3 months prior to screening; or positive test results for human immunodeficiency virus antibody (HIVab) at Screening

• Taking any prescription medication or over the counter multi-vitamin supplement, or any non-prescription products (including herbal-containing preparations but excluding acetaminophen) within 14 days prior to Day -1.

Related Conditions & MeSH terms

• Drug Interaction Potentiation

Intervention

Drug:
• Vadadustat
Oral dose 600 mg
• Furosemide
Oral Furosemide
• Adefovir
Oral Adefovir
• Digoxin
Oral Digoxin

Locations

Country	Name	City	State
Canada	inVentiv Health Clinique Inc.	Québec City	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Akebia Therapeutics

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) for digoxin, adefovir and furosemide		Up to 12 Weeks
Primary	Area under plasma concentration-time curve from 0 to infinity (AUCinf) for digoxin, adefovir and furosemide		Up to 12 Weeks
Primary	Maximum observed plasma concentration (Cmax) for digoxin, adefovir and furosemide		Up to 12 Weeks
Secondary	Time to maximum observed plasma concentration (Tmax) for digoxin, adefovir and furosemide		Up to 12 Weeks
Secondary	Elimination rate constant (Kel) for digoxin, adefovir and furosemide		Up to 12 Weeks
Secondary	Terminal half-life (t½) for digoxin, adefovir and furosemide		Up to 12 Weeks
Secondary	Apparent total body clearance (CL/F) for digoxin, adefovir and furosemide		Up to 12 Weeks
Secondary	Percent of extrapolated area under the curve from time t to infinity (%AUCextrap) for digoxin, adefovir and furosemide		Up to 12 Weeks
Secondary	Reporting of Treatment Emergent Adverse Events (TEAEs) as reported by study subjects		Up to 12 Weeks