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

NCT ID: NCT01473069

Last Updated: 2011-11-21

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-07-31

Brief Summary

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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

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Conditions

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Healthy

Keywords

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JTK-853 Healthy subjects

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, 400 mg ketoconazole

Group Type EXPERIMENTAL

JTK-853, ketoconazole

Intervention Type DRUG

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

Dose 2 JTK-853

Group Type EXPERIMENTAL

JTK-853 or Placebo

Intervention Type DRUG

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

Dose 3 JTK-853

Group Type EXPERIMENTAL

JTK-853 or Placebo

Intervention Type DRUG

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

Dose 4 JTK-853

Group Type EXPERIMENTAL

JTK-853 or Placebo

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

JTK-853 or Placebo

Intervention Type DRUG

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

Interventions

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JTK-853, ketoconazole

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

Intervention Type DRUG

JTK-853 or Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

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-10-003

Identifier Type: -

Identifier Source: org_study_id