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

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: JTK-853, ketoconazole; Drug: JTK-853 or Placebo

• Registration Number: NCT01473069
• Lead Sponsor: Akros Pharma Inc.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2011-11
• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-17
• Last Update Submitted: 2011-11-17
• Last Update Posted: 2011-11-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 1 JTK-853, 400 mg ketoconazole	JTK-853, ketoconazole	-
Dose 2 JTK-853	JTK-853 or Placebo	-
Dose 3 JTK-853	JTK-853 or Placebo	-
Dose 4 JTK-853	JTK-853 or Placebo	-
Placebo	JTK-853 or Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events	3 weeks

Secondary Outcome Measures

Name	Time	Method
Maximum concentration (Cmax) of JTK-853 and metabolite M2	3 weeks
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
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
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

Trial Locations

Locations (1)

PPD Phase I Clinic; 🇺🇸 Austin, Texas, United States