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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01473069
• Other study ID #: AK853-U-10-003
• Status: Terminated
• Phase: Phase 1
• First received: November 9, 2011
• Last updated: November 17, 2011
• Start date: March 2010
• Est. completion date: July 2010

Study information

• Verified date: November 2011
• Source: Akros Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United States	PPD Phase I Clinic	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Akros Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events		3 weeks	Yes
Secondary	Maximum concentration (Cmax) of JTK-853 and metabolite M2		3 weeks	No
Secondary	Time to reach peak or maximum concentration (tmax) for JTK-853 and metabolite M2		3 weeks	No
Secondary	Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2		3 weeks	No
Secondary	Elimination half-life associated with the terminal slope (?z) of a semilogarithmic concentration-time curve (t1/2) for JTK-853 and metabolite M2		3 weeks	No
Secondary	Maximum concentration (Cmax) of JTK-853 and metabolite M2 after Ketoconazole administration		3 weeks	No
Secondary	Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2 after ketoconazole administration		3 weeks	No