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Open-Label, Multiple-Dose, Non-Randomized Study to Assess Drug-Drug Interactions of Proellex® in Female Subjects

NCT00741468 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2014-08-22

Study results available
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Summary

This study will assess possible drug-drug interactions with specific isoenzymes over a total study duration of 6-8 weeks. Blood samples collected pre and post-dose, and urine samples collected post dose will be analyzed.

Conditions

  • Drug Interactions

Interventions

DRUG

Proellex

2, 25 mg Proellex capsules administered daily

DRUG

CYP1A2 probe

Caffeine (200 mg)

DRUG

CYP2C9 probe

Tolbutamide (250 mg)

DRUG

CYP2C19 probe

Omeprazole (20 mg)

DRUG

CYP2D6 probe

Dextromethorphan (30 mg)

DRUG

CYP3A4 probe

Midazolam (2mg)

Sponsors & Collaborators

  • Repros Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Ronald Wiehle, PhD · Repros Therapeutics Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2008-09-30
Completion
2008-10-31

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 NCT00741468 on ClinicalTrials.gov