Bioavailability Study of K0706 in Healthy Subjects

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03316820
• Other study ID #: CLR_17_07
• Status: Completed
• Phase: Phase 1
• Start date: October 28, 2017
• Est. completion date: November 21, 2017

Study information

• Verified date: May 2019
• Source: Sun Pharma Advanced Research Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 21, 2017
• Est. primary completion date: November 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• K0706
Study treatment with water after an overnight fast
• K0706
Study treatment with water after food

Locations

Country	Name	City	State
United States	SPARC Site 1	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharma Advanced Research Company Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observed peak plasma concentration		72 hours
Secondary	Adverse event		26 days