Bioavailability Study of K0706 in Healthy Subjects

Study Overview
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Brief Summary
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This is single-center, single-dose, randomized, open-label, four-period, four sequence crossover study to evaluate the relative bioavailability of K0706 24 mg tablet formulation relative to 24 mg capsule formulation under fasted conditions and to evaluate the food-effect for tablet formulation in healthy subjects.

Official Title
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A Randomized, Open Label, Four Period, Four Sequence, Single Dose, Crossover Study to Evaluate Relative Bioavailability of K0706 24 mg Tablet Formulation Relative to 24 mg Capsule Formulation Under Fasted Conditions and to Evaluate the Food Effect for Tablet Formulation in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: K0706
* Drug: K0706


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willingness to provide written, informed consent for participation in the study in the compliance with the protocol requirements Adult males or females aged between 18 and 55 years Medically healthy on the basis of medical history and physical examination Woman of childbearing potential must practice an acceptable method of birth control Exclusion Criteria: History of any major surgical or medical conditions within 4 weeks prior to dosing History of blood transfusion and / or plasmapheresis within 4 weeks prior to dosing Inability to swallow oral medication and / or difficulty to find peripheral access to veins or inability to undergo venipuncture Any malignancy within the past 3 years (except for non-melanoma skin cancer or cervical cancer in situ)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>K0706 tablet | Drug: K0706<br>* Study treatment with water after an overnight fast<br>Drug: K0706<br>* Study treatment with water after food<br>|
| Experimental: Treatment B<br>K0706 tablet | Drug: K0706<br>* Study treatment with water after an overnight fast<br>Drug: K0706<br>* Study treatment with water after food<br>|
| Experimental: Treatment C<br>K0706 tablet | Drug: K0706<br>* Study treatment with water after an overnight fast<br>Drug: K0706<br>* Study treatment with water after food<br>|
| Experimental: Treatment D<br>K0706 capsule | Drug: K0706<br>* Study treatment with water after an overnight fast<br>Drug: K0706<br>* Study treatment with water after food<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed peak plasma concentration |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event |  | 26 days |