Drug-Drug Interaction Study of Vadadustat With Cyclosporine, Probenecid and Rifampin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-20

Study Completion Date

2018-08-15

Brief Summary

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This is a Phase 1, two-part, open-label study to evaluate the interaction of cyclosporine, probenecid, and rifampin as perpetrators with vadadustat (victim) in healthy male and female subjects.

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Detailed Description

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This is a Phase 1, two-part, open-label study to evaluate the interaction of cyclosporine, probenecid, and rifampin as perpetrators with vadadustat (victim) in healthy male and female subjects. Part 1 consists of 2 arms (cyclosporine and probenecid) and Part 2 consists of 1 arm (rifampin). Twenty (20) unique subjects will be enrolled into each study arm. The PK and safety/tolerability data from Part 1 Arm 1 (cyclosporine) will determine if Part 2 (rifampin) will proceed. Subjects will be on study for up to 72 days, including a 28-day screening period, 6-10 day clinic period, and a 30-day follow-up period post last dose. Blood and/or urine samples for PK analysis will be collected at pre-defined timepoints throughout the study.

Conditions

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Drug Interaction Potentiation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

This is a 2 part study. Part 1 Arm 1 is a cross over design to assess the drug-drug interactions of cyclosporine with vadadustat. Part 1 Arm 2 is a fixed sequence design to assess the drug-drug interactions of probenecid with vadadustat. Part 2 is a crossover design to assess the drug-drug interaction of rifampin with vadadustat

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Vadadustat, Cyclosporine

Part 1: Arm 1: Subjects will receive vadadustat 300 mg alone and vadadustat 300 mg in combination with oral cyclosporine 500 mg in a crossover design

Group Type EXPERIMENTAL

vadadustat

Intervention Type DRUG

Oral dose 300 mg

Cyclosporins

Intervention Type DRUG

Oral Cyclosporine

Vadadustat; Probenecid

Part 1: Arm 2: Subjects will receive vadadustat 300 mg alone and vadadustat 300 mg in combination with oral Probenecid 500 mg Q12h in a fixed sequence design

Group Type EXPERIMENTAL

vadadustat

Intervention Type DRUG

Oral dose 300 mg

Probenecid

Intervention Type DRUG

Oral Probenecid

Vadadustat and Rifampin

Part 2: Subjects will receive vadadustat 300 mg alone and vadadustat 300 mg in combination with IV rifampin 600 mg in a cross-over design

Group Type EXPERIMENTAL

vadadustat

Intervention Type DRUG

Oral dose 300 mg

Rifampin

Intervention Type DRUG

IV Rifampin

Interventions

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vadadustat

Oral dose 300 mg

Intervention Type DRUG

Rifampin

IV Rifampin

Intervention Type DRUG

Probenecid

Oral Probenecid

Intervention Type DRUG

Cyclosporins

Oral Cyclosporine

Intervention Type DRUG

Other Intervention Names

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AKB 6548

Eligibility Criteria

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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; History of latent or active tuberculosis (TB).
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes