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

A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety,Tolerability and Pharmacokinetics of Multiple Ascending Doses of JTK-853 Administered for Two Weeks in Healthy Subjects

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01473069

Enrollment

Registered

2011-11-17

Start date

2010-03-31

Completion date

2010-07-31

Last updated

2011-11-21

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

Conditions

Healthy

Keywords

JTK-853, Healthy subjects

Brief summary

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).

Interventions

DRUGJTK-853, ketoconazole

JTK-853 Tablets or Placebo, twice a day for 14 days, JTK-853 and ketoconazole Tablets, 1 each on Day 15

DRUGJTK-853 or Placebo

JTK-853 Tablets or Placebo, twice a day for 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

1. Body Mass Index (BMI) ≥18.0 kg/m2 and ≤30.0 kg/m2 2. Non-smokers or subjects who have stopped smoking at least 6 months prior to the Screening Visit 3. Female subjects must be either surgically sterile or postmenopausal

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 four weeks prior to Day -1

Design outcomes

Primary

Measure	Time frame
Number of subjects with adverse events	3 weeks

Secondary

Measure	Time frame
Time to reach peak or maximum concentration (tmax) for JTK-853 and metabolite M2	3 weeks
Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2	3 weeks
Maximum concentration (Cmax) of JTK-853 and metabolite M2	3 weeks
Maximum concentration (Cmax) of JTK-853 and metabolite M2 after Ketoconazole administration	3 weeks
Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2 after ketoconazole administration	3 weeks
Elimination half-life associated with the terminal slope (λz) of a semilogarithmic concentration-time curve (t1/2) for JTK-853 and metabolite M2	3 weeks

Countries

United States

Outcome results

None listed

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