Drug-Drug Interaction Study in Healthy Adult Volunteers

Kowa

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: K-877; Drug: Fluconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT02275975

K-877-105

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

20 participants in 2 patient groups

K-877

Experimental group

Description:

K-877

Treatment:

Drug: K-877

K-877 with Fluconazole

Experimental group

Description:

K-877 with Fluconazole

Treatment:

Drug: Fluconazole

Drug: K-877