Bioavailability Study of K0706 in Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: K0706; Drug: K0706

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89121
      • SPARC Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Observed peak plasma concentration	72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse event	26 days

Collaborators and Investigators

• Sponsor: Sun Pharma Advanced Research Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2017
• Primary Completion (Actual): November 21, 2017
• Study Completion (Actual): November 21, 2017

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: October 17, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CLR_17_07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No