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

NCT03702673 | Completed Phase 1 FDA Drug

• 1 other identifier: K-877-101CR
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Treatment emergent adverse events summarized by treatment

  Up to 16 days after administration

Study Arms (4)

Treatment A

EXPERIMENTAL

K-877 CR Tablet A

Drug: K-877 CR Tablet A; Drug: K-877 CR Tablet B; Drug: K-877 CR Tablet E; Drug: K-877 IR Tablet

Treatment B

EXPERIMENTAL

K-877 CR Tablet B

Drug: K-877 CR Tablet A; Drug: K-877 CR Tablet B; Drug: K-877 CR Tablet E; Drug: K-877 IR Tablet

Treatment C

EXPERIMENTAL

K-877 CR Tablet E

Drug: K-877 CR Tablet A; Drug: K-877 CR Tablet B; Drug: K-877 CR Tablet E; Drug: K-877 IR Tablet

Treatment D

EXPERIMENTAL

K-877 IR Tablet

Drug: K-877 CR Tablet A; Drug: K-877 CR Tablet B; Drug: K-877 CR Tablet E; Drug: K-877 IR Tablet

Interventions

K-877 CR Tablet A DRUG

K-877 Controlled Release Tablet A

Treatment A; Treatment B; Treatment C; Treatment D

K-877 CR Tablet B DRUG

K-877 Controlled Release Tablet B

Treatment A; Treatment B; Treatment C; Treatment D

K-877 CR Tablet E DRUG

K-877 Controlled Release Tablet E

Treatment A; Treatment B; Treatment C; Treatment D

K-877 IR Tablet DRUG

K-877 Immediate Release Tablet

Treatment A; Treatment B; Treatment C; Treatment D

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kowa Research Institute, Inc.: lead

Study Sites (1)

PPD Development, LP

Austin, Texas, 78744, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 11, 2018
• Study Start: October 5, 2018
• Primary Completion: November 20, 2018
• Study Completion: November 20, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

US (1)