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A Drug Interaction Study of KW-6356 and Clarithromycin or Rifampicin

NCT04070495 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-11-29

No results posted yet for this study

Summary

The purpose of this study is to investigate the effects of CYP3A4/5 inhibitor or inducer on the pharmacokinetics of KW-6356 when CYP3A4/5 inhibitor or inducer is orally administered to healthy Japanese men for 7 days.

Conditions

Interventions

DRUG

KW-6356

A single oral dose will be administered at Day 1 and 15

DRUG

Clarithromycin

400mg, oral tablet (2 x 200mg), twice daily (BID), Day 8-28

DRUG

Rifampicin

600mg, oral tablet (4 x 150mg), once daily (QD), Day 8-21

Sponsors & Collaborators

  • Kyowa Kirin Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
44 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-27
Primary Completion
2019-11-19
Completion
2019-11-19

Countries

  • Japan

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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 NCT04070495 on ClinicalTrials.gov