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Crossover Study of the Safety and PK Properties of Proellex®
Phase 1 trial testing Proellex in Pharmacokinetics in 17 participants. Completed in 23 October 2008.
| Lead sponsor | Repros Therapeutics Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 17 |
| Start date | 11 August 2008 |
| Primary completion | 23 October 2008 |
| Estimated completion | 23 October 2008 |
| Sites | 1 location across United States |
Repros Therapeutics Inc. — full company profile →
Adults 18 to 34, female only, with Pharmacokinetics. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum observed concentration of Proellex
| Group | Value | 95% CI |
|---|---|---|
| 25 mg AMCC Fed | 485.6 | ± 151.3 |
| 25 mg AMCC Fasting | 876.7 | ± 201.9 |
| 50 mg AMCC Fed | 912.9 | ± 157.6 |
| 50 mg AMCC Fasting | 1322.5 | ± 154.5 |
| 50 mg SMCC Fasting | 1346.7 | ± 148.5 |
Area under the plasma concentration curve from time 0 to the last measurable plasma concentration time point, up to 72 hours.
| Group | Value | 95% CI |
|---|---|---|
| 25 mg AMCC Fed | 6142.1 | ± 2845.9 |
| 25 mg AMCC Fasting | 5765.7 | ± 3036.6 |
| 50 mg AMCC Fed | 11094.2 | ± 4209.0 |
| 50 mg AMCC Fasting | 9252.0 | ± 4217.5 |
| 50 mg SMCC Fasting | 9576.2 | ± 4328.3 |
Time to maximum plasma occurrence of Cmax
| Group | Value | 95% CI |
|---|---|---|
| 25 mg AMCC Fed | 2.6 | ± 0.6 |
| 25 mg AMCC Fasting | 0.8 | ± 0.2 |
| 50 mg AMCC Fed | 2.6 | ± 1.0 |
| 50 mg AMCC Fasting | 0.9 | ± 0.4 |
| 50 mg SMCC Fasting | 0.7 | ± 0.2 |
Area under the plasma concentration curve from time 0 to extrapolated to infinity, calculated by summing the area under the curve from time zero to the time of the last quantifiable concentration
| Group | Value | 95% CI |
|---|---|---|
| 25 mg AMCC Fed | 7039.8 | ± 3715.6 |
| 25 mg AMCC Fasting | 6897.0 | ± 4440.7 |
| 50 mg AMCC Fed | 13014.9 | ± 6753.2 |
| 50 mg AMCC Fasting | 11271.6 | ± 6726.6 |
| 50 mg SMCC Fasting | 11804.8 | ± 7186.9 |
Time to maximum plasma occurrence of T1/2, calculated as ln(2)/Elimination rate constant.
| Group | Value | 95% CI |
|---|---|---|
| 25 mg AMCC Fed | 22.1 | ± 8.2 |
| 25 mg AMCC Fasting | 25.2 | ± 10.4 |
| 50 mg AMCC Fed | 23.8 | ± 10.8 |
| 50 mg AMCC Fasting | 26.7 | ± 11.8 |
| 50 mg SMCC Fasting | 27.5 | ± 11.9 |
Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | 25 mg AMCC Fed | 25 mg AMCC Fasting | 50 mg AMCC Fed | 50 mg AMCC Fasting | 50 mg SMCC Fasting |
|---|---|---|---|---|---|---|
| Oligomenorrhea | Reproductive system and breast disorders | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — |
| Hyperkalemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Presyncope | Nervous system disorders | — | — | — | — | — |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Palpitations | Cardiac disorders | — | — | — | — | — |
| Tachycardia | Cardiac disorders | — | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — | — |
| Pelvi pain NOS | Reproductive system and breast disorders | — | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — |
| Nipple pain | Reproductive system and breast disorders | — | — | — | — | — |
Data from ClinicalTrials.gov NCT00749879 adverse events section.
Study to evaluate the PK of 25 mg and 50 mg of Proellex from 2 different suppliers in the fed and fasting states.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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