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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 4, 2008 | ||||
| Last Updated Date | June 2, 2009 | ||||
| Start Date ICMJE | February 2008 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To determine and compare the pharmacokinetic (PK) properties of a single dose of Proellex® (25 mg) using two different formulations of the drug in healthy adult female subjects with or without fasting [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00620503 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To determine and compare the safety of a single dose of Proellex® (25 mg) using two formulations of the drug in healthy adult female subjects with or without fasting [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Proellex® Pharmacokinetic Bridging Study II | ||||
| Official Title ICMJE | Proellex® Pharmacokinetic Bridging Study II | ||||
| Brief Summary | This is an open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years. Twelve female subjects will each receive a single dose of Proellex®: 25 mg (fed state, formulation A), 25 mg (fed state, formulation B), and 25 mg (fasting state, formulation B); successive dosing will be separated by at least one week intervals from the previous dosing. Blood will be collected prior to taking the dose, and following the dose for 24 hours post-dose. Subjects will be discharged from the study after the last blood sample is obtained after the third dose of Proellex®. Safety will be assessed throughout the study. |
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| Detailed Description | |||||
| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study | ||||
| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Drug: Proellex 25 mg | ||||
| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 12 | ||||
| Completion Date | April 2008 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 34 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00620503 | ||||
| Responsible Party | Andre vanAs, MD, PhD, Repros Therapeutics, Inc. | ||||
| Study ID Numbers ICMJE | ZP-002 | ||||
| Study Sponsor ICMJE | Repros Therapeutics Inc. | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Repros Therapeutics Inc. | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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