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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01475981

Enrollment

Registered

2011-11-22

Start date

2010-01-31

Completion date

2010-04-30

Last updated

2011-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

JTK-853, single dose

Brief summary

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.

Interventions

DRUGJTK-853 or Placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

1. Body mass index (BMI) of 18-30 kg/m2 (inclusive) 2. Non-smokers or subjects who have stopped smoking at least 6 months prior to the Screening Visit

Exclusion criteria

1. History or presence of cardiac disease, including a family history of long-QT syndrome or unexplained sudden death 2. Have used any prescription medication, herbal product, or over-the-counter (OTC) medication (except acetaminophen), within 4 weeks prior to the Day before dosing

Design outcomes

Primary

Measure	Time frame
Number of subjects with adverse events	1 week
Maximum concentration (Cmax) of JTK-853 and metabolite M2	1 week
Time to reach peak or maximum concentration following drug administration (tmax) for JTK-853 and metabolite M2	1 week
Area under the concentration-time curve from the time of dosing to the last quantifiable time point (AUClast) for JTK-853 and metabolite M2	1 week
Area under the concentration-time curve from the time of dosing to infinity (AUCinf) for JTK-853 and metabolite M2	1 week
Elimination half-life associated with the terminal slope (λz) of a semilogarithmic concentration-time curve (t1/2) for JTK-853 and metabolite M2	1 week

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026