Drug-drug InteractionPhase 1NCT01991327
Assessment of Drug-Drug Interactions of Androxal With Cytochrome P450 Isoenyzmes in Healthy Males
A Phase 1 study testing Androxal in people with Drug-drug Interaction, run by Repros Therapeutics Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to assess the drug-drug interactions of Androxal with cytochrome P450 isoenzymes, CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in healthy male subjects administered 25 mg Androxal once daily for 3 days. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Drug-drug Interaction
- What is being tested?
- Androxal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jul 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 60 years
- Men 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 institutional review board (IRB)-approved form prior to the initiation of any study procedures;
- Healthy male, between the ages of 18 and 60 years; body mass index (BMI) 19.0-29.9.
- All laboratory tests either within the normal range or assessed as not clinically significant by the Principal Investigator. Any clinically significant deviations outside of the normal range in the opinion of the Principal Investigator will require sponsor approval. A negative hepatitis B surface antigen, hepatitis C antibody or HIV antibody test result within the previous 3 months may be used instead of obtaining a screening laboratory sample for these laboratory tests;
- Ability to complete the study in accordance with the protocol.
Who cannot join
- Known hypersensitivity to Clomid;
- A clinically significant laboratory abnormality or other clinical findings indicative of a clinically significant exclusionary disease including hepatic insufficiency, renal insufficiency, unstable coronary artery disease, malignancy other than basal cell carcinoma or squamous cell carcinoma of the skin or stroke;
- A positive hepatitis screen including hepatitis surface B antigen (HBsAg) and hepatitis C antibody;
- A positive test result for HIV;
- Positive results from a urine screen for substances of abuse;
- A recent history of alcoholism (< 2 years) or of moderate alcohol use (greater than an average of 3 drinks per day or a total of 21 drinks per week) or use of alcohol within 24 hours prior to receiving the first dose of study medication;
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- Use of any recreational drugs within the past year or a previous history of drug abuse;
- Use of an investigational drug or product, or participation in a drug research study within 30 days prior to receiving study medication;
- A clinically significant electrocardiogram (ECG) abnormality;
- A history of difficulty with phlebotomy;
- Donation of blood (1 pint or more) within 30 days, or plasma within 7 days prior to receiving study medication;
- Use of any prescription drug therapy within 14 days prior to receiving study medication;
- Use of any over-the-counter (OTC) drugs for therapeutic purposes within 48 hours prior to receiving study medication; Use of dietary or herbal supplements 14 days prior to study or megavitamin supplements within 48 hours prior to receiving study medication;
- Consumption of any caffeine containing foods or beverages within 48 hours prior to receiving study medication;
- Consumption of any grapefruit or grapefruit-containing juices, vegetables from the mustard green family, and charbroiled meat within 72 hours prior to receiving study medication;
- Current smoker or user of any tobacco products that has smoked in last 30 or 60 days;
- Any condition which, in the opinion of the Principal Investigator, could interfere with the subject's ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the subject if he took part in the study;
- Classified as a cytochrome P450 isoenzyme 2D6 (CYP2D6) "poor metabolizer" as determined by genotyping at the screening visit
- Use of a monoamine oxidase (MAO) Inhibitor in the previous 28 days prior to dose.
- Concurrent use of cimetidine, levodopa, amantadine, other antipsychotics or antidepressants.
- Type I or Type II diabetes
- Clinical evidence of cirrhosis or biopsy proven cirrhosis of any etiology
- Screening liver function tests (ALT, AST, Bil, Alk. Phos) greater than upper limit of normal
- History of hypertension with BP > 150/95 mmHg seated at screening
- History of chronic pancreatitis or cholelithiasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AN OPEN-LABEL, MULTIPLE DOSE STUDY TO ASSESS THE DRUG-DRUG INTERACTIONS OF ANDROXAL WITH CYTOCHROME P450 ISOENZYMES IN HEALTHY MALE SUBJECTS
The primary objective of this study is to assess the drug-drug interactions of Androxal with cytochrome P450 isoenzymes, CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in healthy male subjects administered 25 mg Androxal once daily for 3 days. Secondly, the safety and tolerability of Androxal will be determined in healthy male subjects administered Androxal 25 mg daily for 3 days.
- Conditions
- Drug-drug Interaction
- Being tested
- Androxal, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AndroxalDrug
Also called enclomiphene citrate
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Androxal | Experimental | Androxal 25 mg capsules once a day for 7 days Receives: Drug: Androxal |
| Placebo Androxal | Active comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug-Drug Interaction
The primary objective of this study is to assess the drug-drug interactions of Androxal with cytochrome P450 isoenzymes, CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in healthy male subjects administered 25 mg Androxal once daily for 3 days.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startMay 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-drug InteractionStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT01991327
- Sponsor's protocol ID
- ZA-106
- Status last verified
- Aug 2014
- First submitted
- 18 Nov 2013
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN OPEN-LABEL, MULTIPLE DOSE STUDY TO ASSESS THE DRUG-DRUG INTERACTIONS OF ANDROXAL WITH CYTOCHROME P450 ISOENZYMES IN HEALTHY MALE SUBJECTS
- ClinicalTrials.gov ID
- NCT01991327
- Acronym / sponsor ID
- ZA-106
- Conditions
- Drug-drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 25 Nov 2013 (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.
The primary objective of this study is to assess the drug-drug interactions of Androxal with cytochrome P450 isoenzymes, CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in healthy male subjects administered 25 mg Androxal once daily for 3 days. Secondly, the safety and tolerability of Androxal will be determined in healthy male subjects administered Androxal 25 mg daily for 3 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Androxal | Experimental | Drug: AndroxalAndroxal 25 mg capsules once a day for 7 days |
| Placebo Androxal | Active comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an institutional review board (IRB)-approved form prior to the initiation of any study procedures;
- Healthy male, between the ages of 18 and 60 years; body mass index (BMI) 19.0-29.9.
- All laboratory tests either within the normal range or assessed as not clinically significant by the Principal Investigator. Any clinically significant deviations outside of the normal range in the opinion of the Principal Investigator will require sponsor approval. A negative hepatitis B surface antigen, hepatitis C antibody or HIV antibody test result within the previous 3 months may be used instead of obtaining a screening laboratory sample for these laboratory tests;
- Ability to complete the study in accordance with the protocol.
Key exclusion criteria (25 listed)
- Known hypersensitivity to Clomid;
- A clinically significant laboratory abnormality or other clinical findings indicative of a clinically significant exclusionary disease including hepatic insufficiency, renal insufficiency, unstable coronary artery disease, malignancy other than basal cell carcinoma or squamous cell carcinoma of the skin or stroke;
- A positive hepatitis screen including hepatitis surface B antigen (HBsAg) and hepatitis C antibody;
- A positive test result for HIV;
- Positive results from a urine screen for substances of abuse;
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 |
|---|---|---|
| AndroxalAlso: enclomiphene citrate | Drug | Androxal |
| Placebo | Drug | Placebo Androxal |
Primary outcome
Drug-Drug Interaction
Time frame: 3 days
The primary objective of this study is to assess the drug-drug interactions of Androxal with cytochrome P450 isoenzymes, CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in healthy male subjects administered 25 mg Androxal once daily for 3 days.
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 11 Aug 2014.
- Sponsor corporate websiteLink provided by the sponsor.
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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 Androxal in people with Drug-drug Interaction, 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 4 inclusion and 25 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 11 Aug 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?
Drug-Drug Interaction (time frame: 3 days). 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 11 Aug 2014.