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

This study has been terminated.

Sponsor:

Information provided by (Responsible Party):

Akros Pharma Inc.

ClinicalTrials.gov Identifier:

NCT01473069

First received: November 9, 2011

Last updated: November 17, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 9, 2011

Last Updated Date

November 17, 2011

Start Date ^ICMJE

March 2010

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of subjects with adverse events [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01473069 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Maximum concentration (Cmax) of JTK-853 and metabolite M2 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Time to reach peak or maximum concentration (tmax) for JTK-853 and metabolite M2 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Elimination half-life associated with the terminal slope (λz) of a semilogarithmic concentration-time curve (t1/2) for JTK-853 and metabolite M2 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Maximum concentration (Cmax) of JTK-853 and metabolite M2 after Ketoconazole administration [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2 after ketoconazole administration [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Maximum concentration (Cmax), time to reach Cmax (tmax), area under the concentration-time curve (AUC) and elimination half life (t1/2) of JTK-853 and metabolite M2 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Area under the concentration-time curve (AUC) and maximum concentration (Cmax) of JTK-853 and metabolite M2 after Ketoconazole administration [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Healthy

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Dose 1 JTK-853, 400 mg ketoconazole
Intervention: Drug: JTK-853, ketoconazole
Experimental: Dose 2 JTK-853
Intervention: Drug: JTK-853 or Placebo
Experimental: Dose 3 JTK-853
Intervention: Drug: JTK-853 or Placebo
Experimental: Dose 4 JTK-853
Intervention: Drug: JTK-853 or Placebo
Placebo Comparator: Placebo
Intervention: Drug: JTK-853 or Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

July 2010

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01473069

Other Study ID Numbers ^ICMJE

AK853-U-10-003

Has Data Monitoring Committee

Responsible Party

Akros Pharma Inc.

Study Sponsor ^ICMJE

Akros Pharma Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Shoji Hoshino, D.V.M

Akros Pharma Inc.

Information Provided By

Akros Pharma Inc.

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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