Proellex® Pharmacokinetic Bridging Study II

NCT00620503 | Completed Phase 1 Results

• 1 other identifier: ZP-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

PK; Pharmacokinetics

Outcome Measures

Primary Outcomes (5)

• Cmax of Proellex

  Maximum observed concentration (Cmax) of a single dose of Proellex® (25 mg) Formulation A using two different formulations of the drug in healthy adult female subjects with or without fasting

  24 hours

• AUC0-last of Proellex

  Area under the plasma concentration curve from time 0 (AUC0-last) to the last measurable plasma concentration time point, up to 24 hours.

  Up to 24 hours

• Tmax

  Time to maximum plasma occurrence of Cmax

  24 hours

• AUC0-infinity of Proellex

  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

  24 hours

• Terminal Elimination Half-life (T1/2) of Proellex

  Time to maximum plasma occurrence of T1/2, calculated as ln(2)/Elimination rate constant.

  24 hours

Study Arms (3)

Formulation A Fed

EXPERIMENTAL

Single dose of Proellex 25 mg formulation A, fed

Drug: Proellex 25 mg formulation A

Formulation B Fed

EXPERIMENTAL

Single dose of Proellex 25 mg formulation B, fed

Drug: Proellex 25 mg formulation B

Formulation B Fasted

EXPERIMENTAL

Single dose of Proellex 25 mg formulation B, fasted

Drug: Proellex 25 mg formulation B

Interventions

Proellex 25 mg formulation A DRUG

One Proellex 25 mg formulation A capsule

Also known as: Telapristonee acetate

Formulation A Fed

Proellex 25 mg formulation B DRUG

One 25 mg Proellex capsule formulation B administered both fed and fasted

Also known as: Telapristone acetate

Formulation B Fasted; Formulation B Fed

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject must be able to speak, read and understand English and be willing and able to provide written informed consent on an Institutional Review Board (IRB)-approved form prior to the initiation of any study procedures. Subject must have signed and dated a written Informed Consent Form (ICF) before undergoing any study related activities, including discontinuation of any prohibited medications
• Premenopausal women aged 18 - 34 inclusive with body mass index between 18 and 35 inclusive
• Women of child-bearing potential must be willing to use effective non-hormonal, double-barrier method contraception during the study period and for a minimum of 30 days after discontinuation of the study medication. Women who have had a hysterectomy will be allowed into the study
• Must have a negative urine pregnancy test at screening
• Able to swallow gelatin capsules
• In general good health
• Must have agreed to not attempt to become pregnant at any time during study participation or for 30 days thereafter
• Must not have used tobacco (nicotine products) for at least two years before the study starts
• Must have normal (or abnormal and clinically insignificant) laboratory values at screening
• Willing to remain in the clinic for the screening visit and for the treatment visits
• Available for all treatment and follow-up visits
• Willing to comply with all study procedures

You may not qualify if:

• Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study
• Past or present history of experiencing any allergic reaction to the formulations administered in this study, or in the opinion of the Principal Investigator, suggests an increased potential for an adverse hypersensitivity
• Any medical condition, which, in the judgment of the Principal Investigator, will prevent the subject from starting and/or completing the study
• Past or present history of any significant cardiovascular, renal, hepatic disease, thrombophlebitis, thromboembolic disorders, or cerebrovascular accident requiring ongoing medical therapy or clinical intervention
• A QTc interval of \>450ms at screening
• Subject with abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Principal Investigator
• Subjects with symptomatic uterine fibroids or endometriosis
• Use of other oral contraceptives or hormonal treatments within 30 days of first dose of study medication
• Use of a hormone-releasing intrauterine device
• Subject with a history of alcohol and/or drug abuse
• Known active infection of HIV, Hepatitis A, B or C
• Subject who has participated in a clinical trial with investigational medication within 30 days prior to study medication administration or who plans to take an experimental drug prior to the end of 30 days after participation in this study

Sponsors & Collaborators

• Repros Therapeutics Inc.: lead

Study Sites (1)

Healthcare Discoveries Inc.

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Interventions

telapristone acetate

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Repros Therapeutics Inc, an Allergan Affiliate

IR-CTRegistration@allergan.com

714-246-4500

Study Officials

• Anne Chan

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2008
• First Posted: February 21, 2008
• Study Start: February 29, 2008
• Primary Completion: April 30, 2008
• Study Completion: April 30, 2008
• Last Updated: June 21, 2019
• Results First Posted: June 21, 2019

Record last verified: 2019-06

Locations

US (1)