Compare the Pharmacokinetic of K-877 Controlled Release (CR) and Immediate Release (IR) Tablets in Healthy Adults.

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: K-877 CR Tablet A; Drug: K-877 CR Tablet B; Drug: K-877 CR Tablet E; Drug: K-877 IR Tablet

• Registration Number: NCT03702673
• Lead Sponsor: Kowa Research Institute, Inc.

Brief Summary

A study to compare the pharmacokinetics of 3 types of K-877 controlled release tablets with a current normal K-877 tablet in healthy adult subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-05
• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-11
• Primary Completion: 2018-11-20
• Study Completion: 2018-11-20
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-17
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Subject provides written informed consent before any study-specific evaluation is performed.
• Subject is a healthy adult male or female aged 18 to 45 years, inclusive.
• Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
• Subject meets all inclusion criteria outlined in the clinical study protocol.

Exclusion Criteria

• Subject has clinically relevant abnormalities in the screening or check-in assessments.
• Subject has a supine blood pressure (as measured at Screening during the collection of vital signs) after resting for 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 (males) or 50 mm Hg diastolic (females). If the initial blood pressure is out of range, blood pressure may be repeated after the subject has maintained a rested position in a quiet environment for at least 10 minutes.
• Subject has a supine pulse rate (as measured at Screening during the collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute. If the initial pulse rate is out of range, the pulse rate may be repeated after the subject has maintained a rested position in a quiet environment for at least 10 minutes.
• Subject does not meet any exclusion criteria outlined in the clinical study protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment D	K-877 CR Tablet A	K-877 IR Tablet
Treatment D	K-877 CR Tablet B	K-877 IR Tablet
Treatment A	K-877 CR Tablet E	K-877 CR Tablet A
Treatment D	K-877 CR Tablet E	K-877 IR Tablet
Treatment D	K-877 IR Tablet	K-877 IR Tablet
Treatment A	K-877 CR Tablet A	K-877 CR Tablet A
Treatment A	K-877 CR Tablet B	K-877 CR Tablet A
Treatment A	K-877 IR Tablet	K-877 CR Tablet A
Treatment B	K-877 CR Tablet A	K-877 CR Tablet B
Treatment B	K-877 CR Tablet B	K-877 CR Tablet B
Treatment C	K-877 IR Tablet	K-877 CR Tablet E
Treatment B	K-877 CR Tablet E	K-877 CR Tablet B
Treatment B	K-877 IR Tablet	K-877 CR Tablet B
Treatment C	K-877 CR Tablet A	K-877 CR Tablet E
Treatment C	K-877 CR Tablet B	K-877 CR Tablet E
Treatment C	K-877 CR Tablet E	K-877 CR Tablet E

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration Versus Time Curve (AUC)	Up to 24 hours after single administration
Maximum Measured Plasma Concentration (Cmax)	Up to 24 hours after single administration

Secondary Outcome Measures

Name	Time	Method
Treatment emergent adverse events summarized by treatment	Up to 16 days after administration

Trial Locations

Locations (1)

PPD Development, LP; 🇺🇸 Austin, Texas, United States