HypogonadismPhase 1NCT02233751

Pharmacokinetic Study of Subcutaneous Testosterone Enanthate

A Phase 1 study testing Testosterone enanthate auto-injector in people with Hypogonadism, run by Antares Pharma Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Evaluation of pharmacokinetics of subcutaneous testosterone enanthate Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Hypogonadism
What is being tested?: Testosterone enanthate auto-injector
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Sep 2014to Oct 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult male subjects, 18-55 years of age, inclusive, at the time of signing the informed consent;
Body weight ≥50 kg and body mass index within the range 19-30 kg/m2, inclusive, at screening;
Medically healthy subjects with clinically insignificant screening and check-in results (medical history, 12-lead electrocardiogram [ECG], physical examination, and laboratory tests); and
Subjects who are able to understand and are willing and able to give their signed informed consent before any trial-related procedures are performed.

Who cannot join

Currently diagnosed or a history of asthma, urticarial, angioedema, anaphylaxis, atopic dermatitis, clinically significant abnormality of skin of the abdomen, cancer, diabetes, or any other clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, hematological, dermatological, venereal, neurological, psychiatric, or other major disorders;
History of benign prostate hypertrophy (BPH), prostate cancer, or abnormal prostate specific antigen (PSA) values;
PSA level > 3 ng/ml at screening;
Presence or history of gastrointestinal, hepatic or renal disease, or any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines;
Systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 90 mmHg, and/or pulse rate outside the range of 40 to 100 beats per minute after one repeat at screening or check-in;
Abnormal ECG at screening as judged by the Investigator;

Show all 13Show fewer

History of clinically significant drug and/or food allergies as determined by the Investigator;
Allergy to sesame, sesame oil, or a history of hypersensitivity or idiosyncratic reaction to compounds related to the study drug
Subjects undergoing current treatment with other androgens (i.e. dehydroepiandrosterone [DHEA]), anabolic steroids, other sex hormones, or drugs that interfere with the metabolism of testosterone (i.e. opioids, anastrozole, clomiphene, dutasteride, finasteride, flutamide, ketoconazole, spironolactone, and testolactone);
Subjects treated within the past 12 months with estrogens, gonadotropin releasing hormone (GnRH) agonists, or growth hormone;
Prescription, over the counter medications, vitamins, herbal and dietary supplements taken within 7 days or 5 half-lives (whichever is longer) prior to the dose of study medication and duration of the study;
Positive screen for human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C at screening;
Positive urine screen for drugs of abuse (amphetamine, barbiturates, benzodiazepines, cocaine, marijuana, methadone, methamphetamines, oxycodone, and opiates) or positive breath alcohol test at screening and check-in

Trial locations and contacts

1 site in 1 country.

United States1 site

Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, 45227

Other trials in United States

About this study

Official title: An Open-Label Study to Evaluate the Pharmacokinetics of Testosterone Enanthate After Single-Dose Injection Via QuickShot® Testosterone in Healthy Male Subjects

Evaluation of pharmacokinetics of subcutaneous testosterone enanthate

Read the detailed description

Evaluation of pharmacokinetics and safety profile of testosterone enanthate injected subcutaneously via auto-injector in healthy male volunteers

Conditions: Hypogonadism
Being tested: Testosterone enanthate auto-injector
Keywords: Healthy Adult Males
Medical subject headings: Hypogonadism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Testosterone enanthate auto-injectorCombination product
Randomization then administration of combination product study medication according to group assignment

Study groups in NCT02233751
Study group	Role	What they receive
Testosterone enanthate auto-injector - 50 mg	Experimental	Testosterone enanthate auto-injector - 50 mg (SC injection) Receives: Combination Product: Testosterone enanthate auto-injector
Testosterone enanthate auto-injector - 200 mg	Experimental	Testosterone enanthate auto-injector- 200 mg (SC injection) Receives: Combination Product: Testosterone enanthate auto-injector

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Concentration (Cmax) for Serum Testosterone and Testosterone Enanthate
Cmax = Maximum blood concentration (ng/dL) of TT=Total Testosterone and TE=Testosterone Enanthate
Measured: Maximum serum concentrations occurring during an 8 days study window
Area Under the Concentration-time Curve From Time Zero to Time t
AUC(0-168h) (ng⋅hr/dL) = area under the concentration-time curve from time zero to Day 8 (1 week);
Measured: 168 hrs
Area Under the Concentration-time Curve From Time Zero to Infinity
AUC(0-inf) (ng⋅hr/dL) = area under the concentration-time curve from time zero to infinity
Measured: time zero to infinity

Secondary outcomes (4)

Time to Maximum Concentration (Tmax)(hr)
tmax = Time to reach maximum concentration
Measured: The sample time of Cmax during a 168 hour sampling interval
Half-life (t 1/2)(hr)
t 1/2 = Half-life is the time required for a concentration to reduce to half its initial value
Measured: 168 hours
Clearance CL/F (L/hr)
Clearance - volume of plasma from which TT/TE is completely removed per unit time
Measured: 168 hours
Vd/F (L)
Vd/F (L) = Apparent volume of distribution
Measured: 168 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Oct 2014

First posted8 Sep 2014 (estimated)
Study startSep 2014
Primary completionOct 2014
Study completionOct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypogonadismStudies 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: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02233751
Sponsor's protocol ID: QST-14-004
Status last verified: Jan 2019
First submitted: 2 Sep 2014
Last updated: 19 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
Prostate Cancer, Hypogonadism, Male
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
Not yet recruitingObservational study
Hematological Profile in Children With Numerical Chromosomal Disorders
Down Syndrome, Turner Syndrome
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 3
Safety and Efficacy of Weekly Testosterone Cypionate Auto-Injector in Men With Hypogonadism
Male Hypogonadism

All Hypogonadism trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Study to Evaluate the Pharmacokinetics of Testosterone Enanthate After Single-Dose Injection Via QuickShot® Testosterone in Healthy Male Subjects
ClinicalTrials.gov ID: NCT02233751
Acronym / sponsor ID: QST-14-004
Conditions: Hypogonadism
Keywords: Healthy Adult Males
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Antares Pharma Inc.Industry (pharma, biotech, devices)
Study start: Sep 2014
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 8 Sep 2014 (estimated)
Results: Posted 19 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Evaluation of pharmacokinetics of subcutaneous testosterone enanthate

Detailed description

Evaluation of pharmacokinetics and safety profile of testosterone enanthate injected subcutaneously via auto-injector in healthy male volunteers

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Testosterone enanthate auto-injector - 50 mg	Experimental	Combination Product: Testosterone enanthate auto-injectorTestosterone enanthate auto-injector - 50 mg (SC injection)
Testosterone enanthate auto-injector - 200 mg	Experimental	Combination Product: Testosterone enanthate auto-injectorTestosterone enanthate auto-injector- 200 mg (SC injection)

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy adult male subjects, 18-55 years of age, inclusive, at the time of signing the informed consent;
Body weight ≥50 kg and body mass index within the range 19-30 kg/m2, inclusive, at screening;
Medically healthy subjects with clinically insignificant screening and check-in results (medical history, 12-lead electrocardiogram [ECG], physical examination, and laboratory tests); and
Subjects who are able to understand and are willing and able to give their signed informed consent before any trial-related procedures are performed.

Key exclusion criteria (13 listed)

Currently diagnosed or a history of asthma, urticarial, angioedema, anaphylaxis, atopic dermatitis, clinically significant abnormality of skin of the abdomen, cancer, diabetes, or any other clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, hematological, dermatological, venereal, neurological, psychiatric, or other major disorders;
History of benign prostate hypertrophy (BPH), prostate cancer, or abnormal prostate specific antigen (PSA) values;
PSA level > 3 ng/ml at screening;
Presence or history of gastrointestinal, hepatic or renal disease, or any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines;
Systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 90 mmHg, and/or pulse rate outside the range of 40 to 100 beats per minute after one repeat at screening or check-in;

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
Testosterone enanthate auto-injectorRandomization then administration of combination product study medication according to group assignment	Combination product	Testosterone enanthate auto-injector - 200 mg, Testosterone enanthate auto-injector - 50 mg

Primary outcome

Maximum Concentration (Cmax) for Serum Testosterone and Testosterone Enanthate
Time frame: Maximum serum concentrations occurring during an 8 days study window
Cmax = Maximum blood concentration (ng/dL) of TT=Total Testosterone and TE=Testosterone Enanthate
Area Under the Concentration-time Curve From Time Zero to Time t
Time frame: 168 hrs
AUC(0-168h) (ng⋅hr/dL) = area under the concentration-time curve from time zero to Day 8 (1 week);
Area Under the Concentration-time Curve From Time Zero to Infinity
Time frame: time zero to infinity
AUC(0-inf) (ng⋅hr/dL) = area under the concentration-time curve from time zero to infinity

4 secondary outcomes

Time to Maximum Concentration (Tmax)(hr)
Time frame: The sample time of Cmax during a 168 hour sampling interval
Half-life (t 1/2)(hr)
Time frame: 168 hours
Clearance CL/F (L/hr)
Time frame: 168 hours
Vd/F (L)
Time frame: 168 hours

Results and safety

Results posted to the registry on 19 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Testosterone Enanthate 50 mg	6	6
Testosterone Enanthate 200 mg	6	6

Primary outcome: Maximum Concentration (Cmax) for Serum Testosterone and Testosterone Enanthate

Time frame: Maximum serum concentrations occurring during an 8 days study window. Mean (Standard Deviation). Unit: ng/dL

Measure	Testosterone Enanthate 50 mg n = 6	Testosterone Enanthate 200 mg n = 6
Serum testosterone	773.7 (121.26)	1487.0 (405.34)
Serum testosterone enanthate	49.25 (6.90)	267.33 (75.77)

Population analysed: Healthy normal male volunteers

Primary outcome: Area Under the Concentration-time Curve From Time Zero to Time t

Time frame: 168 hrs. Mean (Standard Deviation). Unit: (ng⋅hr/dL)

Measure	Testosterone Enanthate 50 mg n = 6	Testosterone Enanthate 200 mg n = 6
TT	103731.5 (12591.81)	176112.8 (47349.64)
TE	6122.2 (929.12)	33535.5 (9977.18)

Primary outcome: Area Under the Concentration-time Curve From Time Zero to Infinity

Time frame: time zero to infinity. Mean (Standard Deviation). Unit: (ng⋅hr/dL)

Measure	Testosterone Enanthate 50 mg n = 2	Testosterone Enanthate 200 mg n = 3
TT	279062.2 (35973.32)	362627.4 (138773.09)
TE	NA (NA)	62497.5 (24618.09)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 14 days. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Treatment B	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hypogonadism

RecruitingPhase 4
Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
Prostate Cancer, Hypogonadism, Male
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
Not yet recruitingObservational study
Hematological Profile in Children With Numerical Chromosomal Disorders
Down Syndrome, Turner Syndrome
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 3
Safety and Efficacy of Weekly Testosterone Cypionate Auto-Injector in Men With Hypogonadism
Male Hypogonadism

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.

Jonathan Jaffe, MD study director

Antares Pharma Inc.

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 Testosterone enanthate auto-injector in people with Hypogonadism, run by Antares Pharma 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 13 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 19 Apr 2019. 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?

Yes. Results are posted in the registry (first posted 19 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Concentration (Cmax) for Serum Testosterone and Testosterone Enanthate (time frame: Maximum serum concentrations occurring during an 8 days study window). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02233751.

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 19 Apr 2019.