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The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers.

NCT02174250 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-04-25

No results posted yet for this study

Summary

The purpose of this study is to test whether Rifampin affects blood levels of istradefylline in humans. Rifampin could possibly decrease istradefylline levels.

Conditions

Interventions

DRUG

Istradefylline 40 mg

On Day 1, istradefylline 1 × 40-mg tablet administered alone

DRUG

Rifampin 300mg BID + istradefylline 40mg Day 8 only

On Days 1 - 20, rifampin 300mg BID; On Day 8, istradefylline 40 mg administered first with rifampin about 2 hours after istradefylline administration

Sponsors & Collaborators

  • Kyowa Hakko Kirin Pharma, Inc.

    collaborator INDUSTRY

  • Kyowa Kirin Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Marc Cantillon, M.D. · Kyowa Hakko Kirin Pharma, Inc.

  • Amy Zhang, PhD · Kyowa Hakko Kirin Pharma, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-08-31
Completion
2014-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02174250 on ClinicalTrials.gov