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Safety and Pharmacokinetics of Single Oral Doses of MBX-400 in Healthy Volunteers

NCT01433835 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2013-08-02

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and pharmacokinetics following a single oral dose of MBX-400.

Conditions

  • Healthy Adult Subjects

Interventions

DRUG

MBX-400

Capsule(s) for oral administration as a single dose. Planned doses include: 35, 100, 350, 700, 1000 and 1350 mg.

OTHER

Placebo

Capsule(s) for oral administration as a single dose. Planned doses include: 35, 100, 350, 700, 1000 and 1350 mg.

Sponsors & Collaborators

  • Microbiotix, Inc.

    lead INDUSTRY

Principal Investigators

  • Gregory J Tracey, MD · Frontage Clinical Research Center

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
2011-09-30
Primary Completion
2012-08-31
Completion
2012-09-30

Countries

  • United States

Study Locations

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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 NCT01433835 on ClinicalTrials.gov