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

December 17, 2018 updated by: Kowa Research Institute, Inc.

Single-Dose, Randomized, Open-Label, 4-Period, 4-Sequence Crossover Study of Three Prototypes of K-877 CR Tablet and Two K-877 Tablets Administered to Healthy Adult Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78744
        • PPD Development, LP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A
K-877 CR Tablet A
Drug: K-877 CR Tablet A
K-877 Controlled Release Tablet A
Drug: K-877 CR Tablet B
K-877 Controlled Release Tablet B
Drug: K-877 CR Tablet E
K-877 Controlled Release Tablet E
Drug: K-877 IR Tablet
K-877 Immediate Release Tablet
Experimental: Treatment B
K-877 CR Tablet B
Drug: K-877 CR Tablet A
K-877 Controlled Release Tablet A
Drug: K-877 CR Tablet B
K-877 Controlled Release Tablet B
Drug: K-877 CR Tablet E
K-877 Controlled Release Tablet E
Drug: K-877 IR Tablet
K-877 Immediate Release Tablet
Experimental: Treatment C
K-877 CR Tablet E
Drug: K-877 CR Tablet A
K-877 Controlled Release Tablet A
Drug: K-877 CR Tablet B
K-877 Controlled Release Tablet B
Drug: K-877 CR Tablet E
K-877 Controlled Release Tablet E
Drug: K-877 IR Tablet
K-877 Immediate Release Tablet
Experimental: Treatment D
K-877 IR Tablet
Drug: K-877 CR Tablet A
K-877 Controlled Release Tablet A
Drug: K-877 CR Tablet B
K-877 Controlled Release Tablet B
Drug: K-877 CR Tablet E
K-877 Controlled Release Tablet E
Drug: K-877 IR Tablet
K-877 Immediate Release Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area Under the Plasma Concentration Versus Time Curve (AUC)
Time Frame: Up to 24 hours after single administration
Up to 24 hours after single administration
Maximum Measured Plasma Concentration (Cmax)
Time Frame: Up to 24 hours after single administration
Up to 24 hours after single administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Treatment emergent adverse events summarized by treatment
Time Frame: Up to 16 days after administration
Up to 16 days after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kowa Research Institute, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2018

Primary Completion (Actual)

November 20, 2018

Study Completion (Actual)

November 20, 2018

Study Registration Dates

First Submitted

October 8, 2018

First Submitted That Met QC Criteria

October 10, 2018

First Posted (Actual)

October 11, 2018

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 17, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • K-877-101CR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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