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Completed

NCT Number: NCT01475981

Safety, Tolerability and Pharmacokinetics Study Assessing Ascending Single Oral JTK-853 Doses in Healthy Subjects

The purpose of this study was to determine the safety, tolerability and pharmacokinetics of ascending single oral doses of JTK-853 administered under fasted or fed conditions in healthy male subjects.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PPD, Phase I Clinic

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body mass index (BMI) of 18-30 kg/m2 (inclusive)
  • Non-smokers or subjects who have stopped smoking at least 6 months prior to the Screening Visit

Exclusion criteria

  • History or presence of cardiac disease, including a family history of long-QT syndrome or unexplained sudden death
  • Have used any prescription medication, herbal product, or over-the-counter (OTC) medication (except acetaminophen), within 4 weeks prior to the Day before dosing

Treatment and study plan

JTK-853 or Placebo

Drug

Tablets, single dose, fasted, fed or high-fat fed condition

Primary outcomes

  1. Number of subjects with adverse events

    Time frame: 1 week

  2. Maximum concentration (Cmax) of JTK-853 and metabolite M2

    Time frame: 1 week

  3. Time to reach peak or maximum concentration following drug administration (tmax) for JTK-853 and metabolite M2

    Time frame: 1 week

  4. Area under the concentration-time curve from the time of dosing to the last quantifiable time point (AUClast) for JTK-853 and metabolite M2

    Time frame: 1 week

  5. Area under the concentration-time curve from the time of dosing to infinity (AUCinf) for JTK-853 and metabolite M2

    Time frame: 1 week

  6. Elimination half-life associated with the terminal slope (λz) of a semilogarithmic concentration-time curve (t1/2) for JTK-853 and metabolite M2

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Akros Pharma Inc.

Industry

Registry information

Official study title

Randomized,Double-blind,Placebo-controlled,Ascending Dose Part Evaluating Safety,Tolerability and Pharmacokinetics (PK) of JTK-853 (Fasted/Fed) and Randomized,Open-label,Crossover Part Evaluating Food Effect on PK in Healthy Male Subjects

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 22, 2011
Registry last updated
Nov 22, 2011

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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