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A Study of the Safety and Pharmacokinetics of Single Ascending Oral Doses of INX-08189 in Healthy Subjects

NCT01159808 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2012-06-22

No results posted yet for this study

Summary

The purpose of this study is to test the safety of different dose strengths of INX-08189 in healthy adults. The study will also look at how rapidly the drug breaks down in the body (pharmacokinetics or PK). The study objectives include:

* To evaluate the safety of single ascending oral doses of INX-08189 in healthy subjects
* To characterize the pharmacokinetic (PK) profile of single ascending oral doses of INX-08189 in healthy subjects
* To assess the food effect on the PK of a single oral dose of INX-08189

Conditions

  • Healthy

Interventions

DRUG

INX-08189

3, 25 and 100 mg capsules; oral administration, single dose

DRUG

Placebo

matching placebo capsules, oral administration, single dose

Sponsors & Collaborators

Principal Investigators

  • Brian Boehlecke, MD, MSPH

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-08-31
Completion
2010-10-31

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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 NCT01159808 on ClinicalTrials.gov