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Completed

NCT Number: NCT01067807

Proellex Pharmacokinetics Bridging Study

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

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Healthcare Discoveries, Inc

San Antonio, Texas, 78209, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

25 mg Proellex

Drug

25 mg - given as one 25 mg capsule (252 mg of Gelucire and 88 mg of PEG400, original formulation) [Original], single dose

Other names: CDB-4124, Telapristone acetate

50 mg Proellex

Drug

50 mg - given as two 25 mg capsules (blended with microcrystalline cellulose, new formulation) [Blended], single dose

Other names: CDB-4124

Primary outcomes

  1. Proellex peak plasma concentration (Cmax)

    Time frame: 24 hours

  2. Proellex time to peak plasma concentration (tmax).

    Time frame: 24 hours

Secondary outcomes

  1. The area under the plasma concentration over time curve from zero to the last measurable Proellex plasma concentration (AUC0-24) was calculated.

    Time frame: 24 hours

  2. The area under the plasma concentration over time curve from zero to infinity (AUC 0-infinity).

    Time frame: 24 hours

  3. Terminal elimination half-life (t1/2).

    Time frame: 24 hours

  4. Vital signs evaluated at screening, treatment days 0 and 1. Clinical laboratory values obtained at screening, treatment days 0 and 1. Adverse events assessed at treatment visits and followed until resolution.

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Repros Therapeutics Inc.

Industry

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Feb 12, 2010
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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