Drug-Drug Interaction Study in Healthy Adult Volunteers

Sponsor

Kowa Research Institute, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02275988

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the effects of clarithromycin on the pharmacokinetics of K-877 in healthy adult subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: K-877 Drug: Clarithromycin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: K-877 K-877	Drug: K-877
Experimental: K-877 with Clarithromycin K-877 with Clarithromycin	Drug: K-877 Drug: Clarithromycin

Arm

Intervention/Treatment

Experimental: K-877

K-877

Drug: K-877

Experimental: K-877 with Clarithromycin

K-877 with Clarithromycin

Drug: K-877

Drug: Clarithromycin

Outcome Measures

Primary Outcome Measures

Maximum concentration (Cmax) [72 hours]

Secondary Outcome Measures

Area under concentration curve (AUC) [72 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges or is showing no clinically relevant deviations, as judged by the investigator at Screening.

Exclusion Criteria:

Subject has clinically relevant abnormalities in the screening or check in assessments.
Subject has a blood pressure (as measured at Screening during the collection of vital signs) after resting supine for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (for males) and 50 mm Hg diastolic (for females).
Subject has a supine pulse rate (as measured at Screening during collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PPD	Austin	Texas	United States	78744

Sponsors and Collaborators

Kowa Research Institute, Inc.

Investigators

Study Director: Stuart Campbell, Kowa Research Institute, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kowa Research Institute, Inc.

ClinicalTrials.gov Identifier:

NCT02275988

Other Study ID Numbers:

K-877-104

First Posted:

Oct 27, 2014

Last Update Posted:

Oct 27, 2014

Last Verified:

Oct 1, 2014

Keywords provided by Kowa Research Institute, Inc.

Adult Volunteers

Additional relevant MeSH terms:

Clarithromycin

Study Results

No Results Posted as of Oct 27, 2014