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To Investigate the Safety and Tolerability of TC-5214 Following Oral Administration of Multiple Doses for up to 8 Days

NCT01145768 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2010-12-08

No results posted yet for this study

Summary

To investigate the safety and tolerability of TC-5214 following oral administration of single and multiple ascending doses compared to placebo.

Conditions

  • Healthy

Interventions

DRUG

TC-5214

4 mg tablet, oral, BID, group 1

DRUG

TC-5214

TBD tablet, oral, BID, groups 2-6

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • David Mathews, MD · Quintiles, Inc.

  • Donna Holloway · Quintiles, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT01145768 on ClinicalTrials.gov