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

NCT ID: NCT01475981

Last Updated: 2011-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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JTK-853 single dose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dose 1 JTK-853 (fasted condition)

Group Type EXPERIMENTAL

JTK-853 or Placebo

Intervention Type DRUG

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

Dose 2 JTK-853 (fasted condition)

Group Type EXPERIMENTAL

JTK-853 or Placebo

Intervention Type DRUG

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

Dose 3 JTK-853 (fasted condition)

Group Type EXPERIMENTAL

JTK-853 or Placebo

Intervention Type DRUG

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

Dose 2 JTK-853 (fed condition)

Group Type EXPERIMENTAL

JTK-853 or Placebo

Intervention Type DRUG

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

Dose 3 JTK-853 (fed condition)

Group Type EXPERIMENTAL

JTK-853 or Placebo

Intervention Type DRUG

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

Dose 4 JTK-853 (fed condition)

Group Type EXPERIMENTAL

JTK-853 or Placebo

Intervention Type DRUG

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

Dose 5 JTK-853 (fed condition)

Group Type EXPERIMENTAL

JTK-853 or Placebo

Intervention Type DRUG

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

Dose 6 JTK-853 (fed condition)

Group Type EXPERIMENTAL

JTK-853 or Placebo

Intervention Type DRUG

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

Dose 7 JTK-853 (fed condition)

Group Type EXPERIMENTAL

JTK-853 or Placebo

Intervention Type DRUG

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

Dose 5 JTK-853 (high-fat fed condition)

Group Type EXPERIMENTAL

JTK-853 or Placebo

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

JTK-853 or Placebo

Intervention Type DRUG

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

Interventions

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JTK-853 or Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Akros Pharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shoji Hoshino, D.V.M

Role: STUDY_DIRECTOR

Akros Pharma Inc.

Locations

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PPD, Phase I Clinic

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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AK853-U-09-001

Identifier Type: -

Identifier Source: org_study_id