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PRA-027 · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PRA-027 | DRUG | PRA-027 capsules; cohort-specific doses or 40, 120, 240 or 500 mg; 1 dose daily for 28 days |
Inclusion Criteria: Inclusion Criteria - All Women * Healthy, nonsmoker or smoker of fewer than 10 cigarettes (half a pack) per day and able to abstain from tobacco throughout all times when in the clinical facility. Inclusion Criteria - Cycling Women * Aged 18 to 45 years, must not be breastfee...
PRA-027 is an investigational small molecule being studied for uterine leiomyomata, also known as fibroids. It is in Phase 1 clinical development and has not been approved by the FDA. Clinical trials have evaluated it in healthy female volunteers and in women with fibroids.
PRA-027 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company has sponsored Phase 1 clinical trials of the drug in the United States and Japan.
PRA-027 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. All completed trials for PRA-027 are Phase 1 studies, and no active trials are currently listed.
PRA-027 has completed three Phase 1 clinical trials: NCT00427544, a safety and pharmacokinetics study in women of nonchildbearing potential in the United States; NCT00444704, a study in healthy Japanese females; and NCT00543790, a multiple ascending dose study in cycling and postmenopausal women.
PRA-027 is the primary name for this investigational drug. No alternative names have been disclosed in the clinical trial records. It is a small molecule being studied for the treatment of uterine fibroids.