HealthyPhase 1NCT02141061
Comparison of Two Formulations of Proellex for Oral Administration
A Phase 1 study testing Telapristone Acetate, Proellex 12 mg Formulation A and Telapristone Acetate, Proellex 12 mg Formulation B in people with Healthy, run by Repros Therapeutics Inc. at 1 site in United States.
Trial summary
This study is a double-blind crossover study in female healthy volunteers to compare the pharmacokinetics and safety of a single dose each of two different formulations of Proellex for oral administration. Each formulation will be designated as either Treatment A or Treatment B. Read more about this study
- Who is it for?
- Ages 18 to 47 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Telapristone Acetate, Proellex 12 mg Formulation A and Telapristone Acetate, Proellex 12 mg Formulation B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jun 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 47 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;
- Healthy, premenopausal female age 18-47;
- History of menstrual events that occur in regular cycles
- Agreement not to attempt to become pregnant
- Agrees to use double-barrier contraception during the study and for 30 days after discontinuation of study medication. Acceptable double-barrier methods are: male condom with spermicide; male condom with diaphragm; diaphragm containing spermicide plus additional intra-vaginal spermicide;
- Has a negative pregnancy test at the Screening visit. An exception for the pregnancy test requirement will be granted for subjects reporting surgical sterilization in medical history
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- Normal laboratory values or clinically insignificant findings at screening as determined by the Investigator;
- Subject is willing to remain in the clinic overnight for PK assessment on Days 0 and 8
- Ability to complete the study procedures in compliance with the protocol.
Who cannot join
- Subject is a post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy
- Subject is pregnant or lactating or is attempting or expecting to become pregnant during the study
- Women with abnormally high liver enzymes or liver disease. (ALT or AST exceeding 2.0 x ULN AND total bilirubin exceeding 1.5 x ULN at screening and confirmed on repeat).
- Received an investigational drug in the 30 days prior to the screening for this study
- Women with a history of PCOS
- Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, DHEA or hormonal products for at least 2 weeks prior to screening and during the study.
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- Use of oral contraceptives in the preceding 2 weeks. Use of Depo-Provera® in the preceding 10 months.
- Has an IUD in place
- Women currently using narcotics
- Women currently taking spironolactone
- Infectious disease screen is positive for HIV or Hepatitis A, B or C.
- Clinically significant abnormal findings on screening examination or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind Crossover Study in Healthy Volunteers to Compare Two Formulations of Proellex for Oral Administration
This study is a double-blind crossover study in female healthy volunteers to compare the pharmacokinetics and safety of a single dose each of two different formulations of Proellex for oral administration. Each formulation will be designated as either Treatment A or Treatment B. A total of 12 subjects who meet the eligibility criteria will be randomized to receive either Treatment A or Treatment B as their first assigned treatment. After a 7-day washout period subjects will receive the alternative treatment. On the day of each treatment subjects will remain in the clinic overnight and undergo 72-hour pharmacokinetic assessment at the following time points: 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 and 72 hours after administration of study drug.
- Conditions
- Healthy
- Being tested
- Telapristone Acetate, Proellex 12 mg Formulation A, Telapristone Acetate, Proellex 12 mg Formulation B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telapristone Acetate, Proellex 12 mg Formulation ADrug
Also called Proellex
Telapristone Acetate, Proellex 12 mg Formulation BDrug
Also called Proellex
| Study group | Role | What they receive |
|---|---|---|
| Telapristone Acetate, Proellex Formulation A (Treatment A) | Experimental | Subjects who meet the eligibility criteria will be randomized to receive either 12 mg Treatment A or 12 mg Treatment B as their first assigned treatment. After a 7-day washout period subjects will receive the alternative treatment. Receives: Drug: Telapristone Acetate, Proellex 12 mg Formulation A; Drug: Telapristone Acetate, Proellex 12 mg Formulation B |
| Telapristone Acetate, Proellex Formulation B (Treatment B) | Experimental | Subjects who meet the eligibility criteria will be randomized to receive either 12 mg Treatment A or 12 mg Treatment B as their first assigned treatment. After a 7-day washout period subjects will receive the alternative treatment. Receives: Drug: Telapristone Acetate, Proellex 12 mg Formulation A; Drug: Telapristone Acetate, Proellex 12 mg Formulation B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Comparison
To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations of 12 mg Proellex administered orally to female healthy volunteers. On the day of each treatment subjects will remain in the clinic overnight and undergo 72-hour pharmacokinetic assessment at the following time points: 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 and 72 hours after administration of study drug.
Pharmacokinetic Endpoints
- AUC 0-t
- AUC 0-24
- AUC 0-∞
- Cmax
- Tmax
- λz
- t½
Measured: Up to 2 weeks
Dose formulation safety
To determine and compare the safety of a single dose of each of two formulations of 12 mg Proellex administered orally to female healthy volunteers. After the completion of the study; incidence of adverse events, mean change from baseline of laboratory values (hematology, blood chemistry, urinalysis), mean change from baseline of vital signs will be assessed. Vital signs and adverse events will be recorded at each visit.
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141061
- Sponsor's protocol ID
- ZPU-101
- Status last verified
- Sep 2014
- First submitted
- 13 May 2014
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Crossover Study in Healthy Volunteers to Compare Two Formulations of Proellex for Oral Administration
- ClinicalTrials.gov ID
- NCT02141061
- Acronym / sponsor ID
- ZPU-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 19 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a double-blind crossover study in female healthy volunteers to compare the pharmacokinetics and safety of a single dose each of two different formulations of Proellex for oral administration. Each formulation will be designated as either Treatment A or Treatment B. A total of 12 subjects who meet the eligibility criteria will be randomized to receive either Treatment A or Treatment B as their first assigned treatment. After a 7-day washout period subjects will receive the alternative treatment. On the day of each treatment subjects will remain in the clinic overnight and undergo 72-hour pharmacokinetic assessment at the following time points: 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 and 72 hours after administration of study drug.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telapristone Acetate, Proellex Formulation A (Treatment A) | Experimental | Drug: Telapristone Acetate, Proellex 12 mg Formulation A, Drug: Telapristone Acetate, Proellex 12 mg Formulation BSubjects who meet the eligibility criteria will be randomized to receive either 12 mg Treatment A or 12 mg Treatment B as their first assigned treatment. After a 7-day washout period subjects will receive the alternative treatment. |
| Telapristone Acetate, Proellex Formulation B (Treatment B) | Experimental | Drug: Telapristone Acetate, Proellex 12 mg Formulation A, Drug: Telapristone Acetate, Proellex 12 mg Formulation BSubjects who meet the eligibility criteria will be randomized to receive either 12 mg Treatment A or 12 mg Treatment B as their first assigned treatment. After a 7-day washout period subjects will receive the alternative treatment. |
Who may qualify
- Ages
- 18 to 47 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;
- Healthy, premenopausal female age 18-47;
- History of menstrual events that occur in regular cycles
- Agreement not to attempt to become pregnant
- Agrees to use double-barrier contraception during the study and for 30 days after discontinuation of study medication. Acceptable double-barrier methods are: male condom with spermicide; male condom with diaphragm; diaphragm containing spermicide plus additional intra-vaginal spermicide;
Key exclusion criteria (12 listed)
- Subject is a post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy
- Subject is pregnant or lactating or is attempting or expecting to become pregnant during the study
- Women with abnormally high liver enzymes or liver disease. (ALT or AST exceeding 2.0 x ULN AND total bilirubin exceeding 1.5 x ULN at screening and confirmed on repeat).
- Received an investigational drug in the 30 days prior to the screening for this study
- Women with a history of PCOS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telapristone Acetate, Proellex 12 mg Formulation AAlso: Proellex | Drug | Telapristone Acetate, Proellex Formulation A (Treatment A), Telapristone Acetate, Proellex Formulation B (Treatment B) |
| Telapristone Acetate, Proellex 12 mg Formulation BAlso: Proellex | Drug | Telapristone Acetate, Proellex Formulation A (Treatment A), Telapristone Acetate, Proellex Formulation B (Treatment B) |
Primary outcome
Pharmacokinetic Comparison
Time frame: Up to 2 weeks
To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations of 12 mg Proellex administered orally to female healthy volunteers. On the day of each treatment subjects will remain in the clinic overnight and undergo 72-hour pharmacokinetic assessment at the following time points: 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 and 72 hours after administration of study drug. Pharmacokinetic Endpoints * AUC 0-t * AUC 0-24 * AUC 0-∞ * Cmax * Tmax * λz * t½
Dose formulation safety
Time frame: Up to 2 weeks
To determine and compare the safety of a single dose of each of two formulations of 12 mg Proellex administered orally to female healthy volunteers. After the completion of the study; incidence of adverse events, mean change from baseline of laboratory values (hematology, blood chemistry, urinalysis), mean change from baseline of vital signs will be assessed. Vital signs and adverse events will be recorded at each visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Telapristone Acetate, Proellex 12 mg Formulation A and Telapristone Acetate, Proellex 12 mg Formulation B in people with Healthy, run by Repros Therapeutics Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Comparison (time frame: Up to 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2014.