MedTrace Logo

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

NCT01473069 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2011-11-21

No results posted yet for this study

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).

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Akros Pharma Inc.

    lead INDUSTRY

Principal Investigators

  • Shoji Hoshino, D.V.M · Akros Pharma Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01473069 on ClinicalTrials.gov