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Bioavailability Study of K0706 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03316820
Recruitment Status : Completed
First Posted : October 20, 2017
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

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 Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : October 28, 2017
Actual Primary Completion Date : November 21, 2017
Actual Study Completion Date : November 21, 2017

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




Primary Outcome Measures :
  1. Observed peak plasma concentration [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. Adverse event [ Time Frame: 26 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03316820


Locations
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United States, Nevada
SPARC Site 1
Las Vegas, Nevada, United States, 89121
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
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Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT03316820    
Other Study ID Numbers: CLR_17_07
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No