Hypogonadal MalesPhase 1NCT01346319
Study of the Safety, Tolerability and Pharmacokinetics of Testosterone Undecanoate in Hypogonadal Males.
A Phase 1 study testing ABT-SLV361 in people with Hypogonadal Males, run by Abbott at 1 site in United States.
Trial summary
Phase 1 Dose Escalating Study of the safety, tolerability and pharmacokinetics of testosterone in hypogonadal males. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Hypogonadal Males
- What is being tested?
- ABT-SLV361
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Sep 2011
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Serum total testosterone < 300 ng/dL based on two blood samples obtained between 6 and 10 AM on two separate occasions at least 48 hours apart. Previously documented total testosterone results obtained within 6 weeks of Study Day -2 may be used during screening for subjects not currently on androgen replacement therapy, or following washout of androgen replacement therapy.
- Subjects naïve to androgen replacement or washout of 12 weeks following intramuscular androgen injections; 4 weeks following topical or buccal androgens; and 3 weeks following oral androgens. Washout should be completed by Study Day -2.
- Subject is judged to be in good general health as determined by the principal investigator based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12 lead electrocardiogram (ECG) performed at Screening.
- Must voluntarily sign and date each informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Who cannot join
- History of significant sensitivity or allergy to any drug, including androgens, castor oil or product excipients.
- Previous history or current or suspected prostate or breast cancer, and/or previous history of cancer (except basal cell carcinoma of the skin).
- Subjects not on a stable medication regimen for at least three months for the treatment of a chronic condition such as hypertension, hyperlipidemia or diabetes mellitus.
- Use of known inhibitors (e.g., ketoconazole) or inducers (e.g., dexamethasone, phenytoin, rifampin, carbamazepine) of cytochrome P450 3A (CYP3A) within 30 days prior to study drug administration and through the end of the study.
- Use of any drug within 5 half-lives of the last dose in the past 6 months prior to Study Day -2 without principal investigator and/or sponsor approval.
- Receipt of any drug by injection within 30 days or 10 half-lives (which ever is longer) prior to study drug administration without principal investigator and/or sponsor approval.
Trial locations and contacts
1 site in 1 country.
United States1 site
Site Reference ID/Investigator# 51964
Fort Myers, Florida, 33901-0000
About this study
Official title: A Randomized Double-Blind, Placebo-controlled Dose Escalating Study of the Pharmacokinetics, Safety and Tolerability of Testosterone Undecanoate (ABT-SLV361) in Hypogonadal Males
Phase 1 Dose Escalating Study of the safety, tolerability and pharmacokinetics of testosterone in hypogonadal males.
Read the detailed description
M12-778 is a rising multiple dose, randomized, double blind, placebo controlled single center study. It will have 5 dose groups of 20 subjects in dose groups 1,2 and 3 and 24 subjects in dose groups 4 and 5; a total of 84 subjects . There will be a 7 day period between dose groups 1,2 and 3 to assess the safety of increasing to the next dose. Dose groups of 4 and 5 will be run in parallel. Subjects will be confined in center for 20 days for dose groups 1,2 and 3 and 33 days for dose groups 4 and 5.
- Conditions
- Hypogonadal Males
- Being tested
- ABT-SLV361, placebo
- Keywords
- dose escalating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-SLV361Drug
For dose groups 1, 2 and 3 medication is taken 1 time per day the first day followed by 2 times per day for 14 days. For dose groups 4 and 5, medication is taken 1 time per day for the first day followed by 2 times per day for 28 days.
placeboDrug
For dose groups 1, 2 and 3 medication is taken 1 time per day the first day followed by 2 times per day for 14 days. For dose groups 4 and 5, medication is taken 1 time per day for the first day followed by 2 times per day for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Testosterone undecanoate | Active comparator | Not described Receives: Drug: ABT-SLV361 |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the pharmacokinetics of testosterone after multiple oral doses of ABT-SLV361 in hypogonadal males
Blood sample results for testosterone
Measured: During confinement
Secondary outcomes (1)
To determine the pharmacokinetic of testosterone undecanoate after multiple oral doses of ABT-SLV361 in hypogonadal males
Blood sample results for testosterone undecanoate
Measured: During confinement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypogonadal MalesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bela Denes, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346319
- Sponsor's protocol ID
- M12-778
- Status last verified
- Sep 2011
- First submitted
- 20 Apr 2011
- Last updated
- 3 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind, Placebo-controlled Dose Escalating Study of the Pharmacokinetics, Safety and Tolerability of Testosterone Undecanoate (ABT-SLV361) in Hypogonadal Males
- ClinicalTrials.gov ID
- NCT01346319
- Acronym / sponsor ID
- M12-778
- Conditions
- Hypogonadal Males
- Keywords
- dose escalating
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 3 May 2011 (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.
Phase 1 Dose Escalating Study of the safety, tolerability and pharmacokinetics of testosterone in hypogonadal males.
Detailed description
M12-778 is a rising multiple dose, randomized, double blind, placebo controlled single center study. It will have 5 dose groups of 20 subjects in dose groups 1,2 and 3 and 24 subjects in dose groups 4 and 5; a total of 84 subjects . There will be a 7 day period between dose groups 1,2 and 3 to assess the safety of increasing to the next dose. Dose groups of 4 and 5 will be run in parallel. Subjects will be confined in center for 20 days for dose groups 1,2 and 3 and 33 days for dose groups 4 and 5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone undecanoate | Active comparator | Drug: ABT-SLV361 |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Serum total testosterone < 300 ng/dL based on two blood samples obtained between 6 and 10 AM on two separate occasions at least 48 hours apart. Previously documented total testosterone results obtained within 6 weeks of Study Day -2 may be used during screening for subjects not currently on androgen replacement therapy, or following washout of androgen replacement therapy.
- Subjects naïve to androgen replacement or washout of 12 weeks following intramuscular androgen injections; 4 weeks following topical or buccal androgens; and 3 weeks following oral androgens. Washout should be completed by Study Day -2.
- Subject is judged to be in good general health as determined by the principal investigator based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12 lead electrocardiogram (ECG) performed at Screening.
- Must voluntarily sign and date each informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Key exclusion criteria (6 listed)
- History of significant sensitivity or allergy to any drug, including androgens, castor oil or product excipients.
- Previous history or current or suspected prostate or breast cancer, and/or previous history of cancer (except basal cell carcinoma of the skin).
- Subjects not on a stable medication regimen for at least three months for the treatment of a chronic condition such as hypertension, hyperlipidemia or diabetes mellitus.
- Use of known inhibitors (e.g., ketoconazole) or inducers (e.g., dexamethasone, phenytoin, rifampin, carbamazepine) of cytochrome P450 3A (CYP3A) within 30 days prior to study drug administration and through the end of the study.
- Use of any drug within 5 half-lives of the last dose in the past 6 months prior to Study Day -2 without principal investigator and/or sponsor approval.
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 |
|---|---|---|
| ABT-SLV361For dose groups 1, 2 and 3 medication is taken 1 time per day the first day followed by 2 times per day for 14 days. For dose groups 4 and 5, medication is taken 1 time per day for the first day followed by 2 times per day for 28 days. | Drug | Testosterone undecanoate |
| placeboFor dose groups 1, 2 and 3 medication is taken 1 time per day the first day followed by 2 times per day for 14 days. For dose groups 4 and 5, medication is taken 1 time per day for the first day followed by 2 times per day for 28 days. | Drug | Placebo |
Primary outcome
To determine the pharmacokinetics of testosterone after multiple oral doses of ABT-SLV361 in hypogonadal males
Time frame: During confinement
Blood sample results for testosterone
1 secondary outcome
To determine the pharmacokinetic of testosterone undecanoate after multiple oral doses of ABT-SLV361 in hypogonadal males
Time frame: During confinement
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 Nov 2011.
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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.
Bela Denes, MD study director
Abbott
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 ABT-SLV361 in people with Hypogonadal Males, run by Abbott 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 6 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 Nov 2011. 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. Some participants in this study may receive a placebo. 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?
To determine the pharmacokinetics of testosterone after multiple oral doses of ABT-SLV361 in hypogonadal males (time frame: During confinement). 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 Nov 2011.