Proellex Pharmacokinetics Bridging Study

Repros Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 50 mg Proellex; Drug: 25 mg Proellex

Study type: Interventional

Funder types: Industry

Identifiers

NCT01067807

ZP-001

Details and patient eligibility

About

Healthy female subjects received a single dose of four different types of Proellex, the original 25 mg dose and three new formulations

Full description

Healthy female subjects received a single dose of four different types of Proellex, the original 25 mg dose and three new formulations (24 and 50 mg dose). Blood was collected pre-dose, at specified intervals and 24 hours post dose. Each dose was separated by at least one week interval from the previous dose.

Enrollment: 21 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the clinical Investigator
• Subject was willing to remain in the clinic for the screening visit; and for the treatment visits (day -1, day of treatment and day 1; approximately 36 hrs per treatment visit)

Exclusion criteria

• Post-menopausal women,
• Subject with documented endometriosis
• Subject with known uterine fibroids or vaginal polyps

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 4 patient groups

Proellex Formulation 1

Experimental group

Description:

25 mg Proellex Gelucire and PEG (original formulation)

Treatment:

Drug: 25 mg Proellex

Drug: 25 mg Proellex

Drug: 25 mg Proellex

25 mg Proellex Formulation 2

Experimental group

Description:

25 mg Proellex coated with MCC

Treatment:

Drug: 25 mg Proellex

Drug: 25 mg Proellex

Drug: 25 mg Proellex

25 mg Proellex Formulation 3

Experimental group

Description:

25 mg Proellex blended with MCC

Treatment:

Drug: 25 mg Proellex

Drug: 25 mg Proellex

Drug: 25 mg Proellex

50 mg Proellex Formulation 3

Experimental group

Description:

50 mg Proellex blended with MCC

Treatment:

Drug: 50 mg Proellex