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

NCT ID: NCT03702673

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-05

Study Completion Date

2018-11-20

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Treatment A

K-877 CR Tablet A

Group Type EXPERIMENTAL

K-877 CR Tablet A

Intervention Type DRUG

K-877 Controlled Release Tablet A

K-877 CR Tablet B

Intervention Type DRUG

K-877 Controlled Release Tablet B

K-877 CR Tablet E

Intervention Type DRUG

K-877 Controlled Release Tablet E

K-877 IR Tablet

Intervention Type DRUG

K-877 Immediate Release Tablet

Treatment B

K-877 CR Tablet B

Group Type EXPERIMENTAL

K-877 CR Tablet A

Intervention Type DRUG

K-877 Controlled Release Tablet A

K-877 CR Tablet B

Intervention Type DRUG

K-877 Controlled Release Tablet B

K-877 CR Tablet E

Intervention Type DRUG

K-877 Controlled Release Tablet E

K-877 IR Tablet

Intervention Type DRUG

K-877 Immediate Release Tablet

Treatment C

K-877 CR Tablet E

Group Type EXPERIMENTAL

K-877 CR Tablet A

Intervention Type DRUG

K-877 Controlled Release Tablet A

K-877 CR Tablet B

Intervention Type DRUG

K-877 Controlled Release Tablet B

K-877 CR Tablet E

Intervention Type DRUG

K-877 Controlled Release Tablet E

K-877 IR Tablet

Intervention Type DRUG

K-877 Immediate Release Tablet

Treatment D

K-877 IR Tablet

Group Type EXPERIMENTAL

K-877 CR Tablet A

Intervention Type DRUG

K-877 Controlled Release Tablet A

K-877 CR Tablet B

Intervention Type DRUG

K-877 Controlled Release Tablet B

K-877 CR Tablet E

Intervention Type DRUG

K-877 Controlled Release Tablet E

K-877 IR Tablet

Intervention Type DRUG

K-877 Immediate Release Tablet

Interventions

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K-877 CR Tablet A

K-877 Controlled Release Tablet A

Intervention Type DRUG

K-877 CR Tablet B

K-877 Controlled Release Tablet B

Intervention Type DRUG

K-877 CR Tablet E

K-877 Controlled Release Tablet E

Intervention Type DRUG

K-877 IR Tablet

K-877 Immediate Release Tablet

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kowa Research Institute, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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PPD Development, LP

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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K-877-101CR

Identifier Type: -

Identifier Source: org_study_id