Two Week Study Evaluating Safety, Tolerability and Pharmacokinetics of Multiple Doses of JTK-853 in Healthy Subjects

Stopped early · 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 sequential ascending doses of JTK-853 administered for 14 days in healthy subjects and also to determine the effect of a single dose of ketoconazole on the steady-state pharmacokinetic profile of JTK-853 and its metabolite M2 (one cohort only).

Key facts

Study ID

NCT01473069

Run by

Akros Pharma Inc.

People needed

41

Starts

2010-03-01

Expected to finish

2010-07-01

Last updated by the study team

2011-11-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Body Mass Index (BMI) ≥18.0 kg/m2 and ≤30.0 kg/m2
• Non-smokers or subjects who have stopped smoking at least 6 months prior to the Screening Visit
• Female subjects must be either surgically sterile or postmenopausal

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 four weeks prior to Day -1

Where it is running

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

Full record on ClinicalTrials.gov

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