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

Study Overview
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: K-877 CR Tablet A
* Drug: K-877 CR Tablet B
* Drug: K-877 CR Tablet E
* Drug: K-877 IR Tablet


Participation Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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