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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03801759
Other study ID # AKB-6548-CI-0031
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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