Bioavailability Study of K0706 in Healthy Subjects

• Sponsor: Sun Pharma Advanced Research Company Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03316820
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 4
• Actual Duration (Days): 24
• Patients Per Site Per Month: 30.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: K0706; Drug: K0706	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Oct 28, 2017
• Actual Primary Completion Date: Nov 21, 2017
• Actual Study Completion Date: Nov 21, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A K0706 tablet	Drug: K0706; Study treatment with water after an overnight fast; Drug: K0706; Study treatment with water after food
Experimental: Treatment B K0706 tablet	Drug: K0706; Study treatment with water after an overnight fast; Drug: K0706; Study treatment with water after food
Experimental: Treatment C K0706 tablet	Drug: K0706; Study treatment with water after an overnight fast; Drug: K0706; Study treatment with water after food
Experimental: Treatment D K0706 capsule	Drug: K0706; Study treatment with water after an overnight fast; Drug: K0706; Study treatment with water after food

Outcome Measures

Primary Outcome Measures

1. Observed peak plasma concentration [72 hours]

Secondary Outcome Measures

1. Adverse event [26 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Willingness to provide written, informed consent for participation in the study in the compliance with the protocol requirements

2. Adult males or females aged between 18 and 55 years

3. Medically healthy on the basis of medical history and physical examination

4. Woman of childbearing potential must practice an acceptable method of birth control

Exclusion Criteria:

1. History of any major surgical or medical conditions within 4 weeks prior to dosing

2. History of blood transfusion and / or plasmapheresis within 4 weeks prior to dosing

3. Inability to swallow oral medication and / or difficulty to find peripheral access to veins or inability to undergo venipuncture

4. Any malignancy within the past 3 years (except for non-melanoma skin cancer or cervical cancer in situ)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SPARC Site 1	Las Vegas	Nevada	United States	89121

Sponsors and Collaborators

• Sun Pharma Advanced Research Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sun Pharma Advanced Research Company Limited
• ClinicalTrials.gov Identifier: NCT03316820
• Other Study ID Numbers: CLR_17_07
• First Posted: Oct 20, 2017
• Last Update Posted: May 3, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 3, 2019