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Completed

NCT Number: NCT03316820

Bioavailability Study of K0706 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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SPARC Site 1

Las Vegas, Nevada, 89121, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

K0706

Drug

Study treatment with water after an overnight fast

Primary outcomes

  1. Observed peak plasma concentration

    Time frame: 72 hours

Secondary outcomes

  1. Adverse event

    Time frame: 26 days

Sponsors and collaborators

Lead sponsor

Sun Pharma Advanced Research Company Limited

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 20, 2017
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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