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Comparison of Two Formulations of Proellex for Oral Administration

NCT02141061 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-09-03

No results posted yet for this study

Summary

This study is a double-blind crossover study in female healthy volunteers to compare the pharmacokinetics and safety of a single dose each of two different formulations of Proellex for oral administration. Each formulation will be designated as either Treatment A or Treatment B. A total of 12 subjects who meet the eligibility criteria will be randomized to receive either Treatment A or Treatment B as their first assigned treatment. After a 7-day washout period subjects will receive the alternative treatment. On the day of each treatment subjects will remain in the clinic overnight and undergo 72-hour pharmacokinetic assessment at the following time points: 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 and 72 hours after administration of study drug.

Conditions

  • Healthy

Interventions

DRUG

Telapristone Acetate, Proellex 12 mg Formulation A

DRUG

Telapristone Acetate, Proellex 12 mg Formulation B

Sponsors & Collaborators

  • Repros Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
47 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-06-30
Completion
2014-06-30

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 NCT02141061 on ClinicalTrials.gov