Drug-Drug Interaction Study to Assess the Effects of Multiple-Dose Administration of K-877 on the Pharmacodynamics and the Pharmacokinetics of Multiple-Dose Administration of Warfarin in Healthy Adult Volunteers

• Sponsor: Kowa Research Institute, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02719431
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 1
• Patients Per Site Per Month: 19.6

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the effects of K-877 on the pharmacodynamics and the pharmacokinetics of warfarin in healthy adults volunteers.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Warfarin/Warfarin + K-877	Drug: Warfarin; Drug: K-877

Outcome Measures

Primary Outcome Measures

1. International normalized ratio (INR) [22 Days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subject provides written informed consent before any study specific evaluation is performed.

• Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive.

• Subject has a body mass index of 18 to 30 kg/m², inclusive.

Exclusion Criteria:

• Subject has clinically relevant abnormalities in the screening or check in assessments.

• Subject has clinically significant out-of-range PT, INR, activated partial thromboplastin time, fibrinogen, protein C, or protein S.

• Subject has abnormal prolongation of skin bleeding time at Screening.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Austin	Texas	United States

Sponsors and Collaborators

• Kowa Research Institute, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kowa Research Institute, Inc.
• ClinicalTrials.gov Identifier: NCT02719431
• Other Study ID Numbers: K-877-108
• First Posted: Mar 25, 2016
• Last Update Posted: Mar 25, 2016
• Last Verified: Mar 1, 2016

• Additional relevant MeSH terms: Warfarin

Study Results

No Results Posted as of Mar 25, 2016