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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01475981

Run by

Akros Pharma Inc.

People needed

70

Starts

2010-01-01

Expected to finish

2010-04-01

Last updated by the study team

2011-11-22

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• PPD, Phase I Clinic — Austin, Texas, United States

Full record on ClinicalTrials.gov

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