HypogonadismPhase 2NCT02921386
The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate
A Phase 2 study testing Oral Testosterone Undecanoate in people with Hypogonadism, run by Clarus Therapeutics, Inc. at 2 sites in United States.
Trial summary
A Phase 2, open-label, randomized, cross-over, pharmacokinetic study designed to determine the effect of meals of various amounts of fat given immediately prior to dosing on the pharmacokinetics of oral testosterone undecanoate. Approximately 20 hypogonadal subjects will be dosed for a 14 day run-in period. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Hypogonadism
- What is being tested?
- Oral Testosterone Undecanoate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2016to 21 Jan 2017
- Phase
- Phase 2
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man 18 to 65 years of age, inclusive, with a clinical diagnosis of hypogonadism (signs/symptoms consistent with hypogonadism for testosterone naïve subjects and history of signs/symptoms for subjects who have received prior treatment) as well as testosterone levels consistent with hypogonadism as defined by 2 morning total T values of <300 ng/dL (between 6:00 and 10:00 AM drawn on 2 separate days [approximately 7 (±2) days apart].
- Adequate venous access in the left or right arm to allow collection of a number of blood samples via a venous cannula.
- Must be naïve to androgen-replacement therapy or washed out of prior androgen replacement therapies; that is, be willing to cease current T treatment or currently not be taking T treatment, (washout durations specified in exclusion criterion #1). Subjects must remain off all forms of T, except for dispensed study drug, throughout the entire study.
- Subjects on replacement therapy for hypopituitarism or multiple endocrine deficiencies must be on stable doses of thyroid hormone and adrenal replacement hormones for at least 14 days before Screen 1.
- Has voluntarily given written informed consent to participate in this study.
Who cannot join
- Received oral topical (eg, gel or patch), intranasal, or buccal T therapy within the previous 2 weeks, intramuscular T injection of short-acting duration (eg, T enanthate, T cypionate) within the previous 4 weeks, intramuscular T injection of long-acting duration (eg, AVEED) within the previous 20 weeks, or T implantable pellets (Testopel®) within the previous 6 months.
- Has an intercurrent disease deemed clinically significant in the opinion of the investigator of any type; in particular, liver, kidney, uncontrolled or poorly controlled heart disease, including hypertension, congestive heart failure or coronary heart disease, or psychiatric-illness, including severe depression.
- Has had a recent (within 2 years) history of stroke, transient ischemic attack, or acute coronary event.
- Has a mean of the triplicate assessment of sBP > 150 mm Hg and/or dBP > 90 mm Hg at screening (if prescribed antihypertensives, subject should be taking medications on the day of the screening visit with a sip of water). Subjects < 60 years of age and prescribed antihypertensives will be excluded if the mean of the triplicate assessment of sBP > 140 mm Hg and/or dBP > 90 mm Hg at screening.
- Has had recent (within 2 years) history of angina or stent (coronary or carotid) placement.
- Has untreated, severe obstructive sleep apnea.
Show all 24Show fewer
- Has clinically significant abnormal laboratory values, including serum transaminases > 2 × upper limits of normal (ULN), serum bilirubin > 1.5 × ULN and serum creatinine > 1.5 × ULN.
- Has a hematocrit (HCT) value of < 35% or > 48%.
- Has a history of polycythemia, either idiopathic or associated with TRT treatment.
- Is a diabetic subject with a glycosylated hemoglobin > 8.5%.
- Has a body mass index (BMI) ≥ 38 kg/m2.
- Has been on stable doses of antihypertensive medication for < 3 months.
- Has an abnormal prostate digital rectal examination [(DRE); palpable nodules], elevated PSA (serum PSA > 4.0 ng/mL), I-PSS > 19 points at screening, and/or history of, or current or suspected, prostate cancer.
- Has a history of, or current or suspected, breast cancer.
- Has a history of abnormal bleeding tendencies or thrombophlebitis unrelated to venipuncture or intravenous cannulation within the previous 2 years.
- Use of dietary supplements such as saw palmetto or phytoestrogens and any dietary supplements that may increase total T, such as androstenedione or dehydroepiandrosterone within the previous 4 weeks.
- Has known malabsorption syndrome and/or current treatment with oral lipase inhibitors (eg, orlistat [Xenical®]) and/or bile acid-binding resins (eg, cholestyramine [Questran®], colestipol [Colestid®]) or treatments that promote gastric emptying (eg, metoclopramide [Reglan®]).
- Inability to observe all rules and smoking restrictions in place at the clinical facility during confinement.
- Has history of abuse of alcohol or any drug substance within the previous 2 years.
- Poor compliance or unlikely to keep clinic appointments and remain for entire confinement period.
- Has received any drug as part of another research study within 30 days of initial dose administration in this study.
- Donated blood (≥ 500 mL) within the 12-week period before the initial study dose.
- Current use of the following groups of drugs that effect T levels, T metabolism or levels of T metabolites, namely antiandrogens, 5-alpha-reductase inhibitors (eg, dutasteride, finasteride), estrogens, long-acting opioid analgesics (eg, methadone hydrochloride, buprenorphine hydrochloride) or human growth hormone (HGH).
- Unwilling or unable to follow the dietary requirements for this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Orlando Clinical Research Center
Orlando, Florida, 32809-3017
Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
Official title: A Phase 2 Study of the Effect of Meals With Various Amounts of Fat Given Immediately After Dosing on the Pharmacokinetics of an Oral Testosterone Undecanoate
A Phase 2, open-label, randomized, cross-over, pharmacokinetic study designed to determine the effect of meals of various amounts of fat given immediately prior to dosing on the pharmacokinetics of oral testosterone undecanoate. Approximately 20 hypogonadal subjects will be dosed for a 14 day run-in period. This will be followed by a randomized sequence of five periods over a 6 day confinement period. Subjects will receive a randomly ordered sequence of breakfast meals containing various amounts of fat, fasting, 15 g, 30 g, 45 g and a high fat breakfast consistent Guidance for Industry on Food-Effect Bioavailability and Fed Bioequivalence Studies.
Read the detailed description
This is a Phase 2, open-label, randomized, cross over, pharmacokinetic study. Subjects will initially be dosed for 2 weeks (Run-In Phase) to allow suppression of endogenous testosterone production, while allowing the oral TU to reach steady state. The subjects will then be confined to a clinical unit in which they undergo the PK Phase of the study. During the PK Phase of the study, subjects will undergo a five-period cross-over in which oral TU is dosed twice daily. Subjects will dose in the morning and in the evening immediately prior to protocol-defined meals. The protocol-defined breakfasts will contain various levels of fat including 15 g, 30 g, 45 g, a breakfast consistent with the fat and calorie content of the high-fat breakfast consistent with recommendations in the Guidance for Industry on Food-Effect Bioavailability and Fed Bioequivalence Studies (December 2002), or while fasting (with no meal until 4 hours post-dose). Subjects will be randomized to a designated sequence of the protocol-defined breakfasts, or the fasted state. The subjects will be required to consume the entire breakfast within 20 minutes during the PK Phase. The protocol-defined evening meal will be required to be consumed within 20 minutes. The 5 meal periods will occur on sequential days.
Approximately twenty (20) subjects will be enrolled in order to ensure completion of 16 subjects.
- Conditions
- Hypogonadism
- Being tested
- Oral Testosterone Undecanoate
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Testosterone UndecanoateDrug
All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods
| Study group | Role | What they receive |
|---|---|---|
| Breakfast A - Fasting | Other | Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to Fasting at breakfast and immediately prior to dinner. Receives: Drug: Oral Testosterone Undecanoate |
| Breakfast B - 15 g fat | Other | Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 15 g fat breakfast and immediately prior to dinner. Receives: Drug: Oral Testosterone Undecanoate |
| Breakfast C - 30 g fat | Other | Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 30 g fat breakfast and immediately prior to dinner. Receives: Drug: Oral Testosterone Undecanoate |
| Breakfast D - 45 g fat | Other | Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 45 g fat breakfast and immediately prior to dinner. Receives: Drug: Oral Testosterone Undecanoate |
| Breakfast E - High Fat | Other | Oral Testosterone Undecanoate 237 mg administered twice daily immediately prior to high fat breakfast and immediately prior to dinner. Receives: Drug: Oral Testosterone Undecanoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax-am for Oral TU Across Breakfast With Varying Fat Content
Peak Concentration after morning dose (Cmax) for oral testosterone undecanoate taken after a fasting breakfast of varying fat content.
Measured: 0, 1, 2, 3, 4, 6, 8, 12 hours post-dose
Time of Peak Concentration (Tmax-am)
The time of peak concentration (Tmax-am) will be assessed within each relevant dosing interval.
Measured: 12 hours
Area Under the Curve (AUC-am)
The 12 hours following morning dose area under the curve (AUC) will assessed for each sequence of breakfasts with varying fat content.
Measured: 0, 1, 2, 3, 4, 6, 8, 12 hours post-dose
Time Weighted Average Total Testosterone Concentration (Cavg-am)
The time weighted average of total testosterone concentration will be assessed for each dosing interval.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion21 Jan 2017
- Study completion21 Jan 2017
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 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Open-label, randomized, 5-period crossover food effect study
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clarus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Ronald Swerdloff, Principal investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921386
- Sponsor's protocol ID
- CLAR-16015
- Status last verified
- Apr 2018
- First submitted
- 29 Sep 2016
- Last updated
- 17 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of the Effect of Meals With Various Amounts of Fat Given Immediately After Dosing on the Pharmacokinetics of an Oral Testosterone Undecanoate
- ClinicalTrials.gov ID
- NCT02921386
- Acronym / sponsor ID
- CLAR-16015
- Conditions
- Hypogonadism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Clarus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- Oct 2016
- Primary completion
- 21 Jan 2017 (actual)
- Study completion
- 21 Jan 2017 (actual)
- First posted
- 3 Oct 2016 (estimated)
- Results
- Posted 12 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2, open-label, randomized, cross-over, pharmacokinetic study designed to determine the effect of meals of various amounts of fat given immediately prior to dosing on the pharmacokinetics of oral testosterone undecanoate. Approximately 20 hypogonadal subjects will be dosed for a 14 day run-in period. This will be followed by a randomized sequence of five periods over a 6 day confinement period. Subjects will receive a randomly ordered sequence of breakfast meals containing various amounts of fat, fasting, 15 g, 30 g, 45 g and a high fat breakfast consistent Guidance for Industry on Food-Effect Bioavailability and Fed Bioequivalence Studies.
Detailed description
This is a Phase 2, open-label, randomized, cross over, pharmacokinetic study. Subjects will initially be dosed for 2 weeks (Run-In Phase) to allow suppression of endogenous testosterone production, while allowing the oral TU to reach steady state. The subjects will then be confined to a clinical unit in which they undergo the PK Phase of the study. During the PK Phase of the study, subjects will undergo a five-period cross-over in which oral TU is dosed twice daily. Subjects will dose in the morning and in the evening immediately prior to protocol-defined meals. The protocol-defined breakfasts will contain various levels of fat including 15 g, 30 g, 45 g, a breakfast consistent with the fat and calorie content of the high-fat breakfast consistent with recommendations in the Guidance for Industry on Food-Effect Bioavailability and Fed Bioequivalence Studies (December 2002), or while fasting (with no meal until 4 hours post-dose). Subjects will be randomized to a designated sequence of the protocol-defined breakfasts, or the fasted state. The subjects will be required to consume the entire breakfast within 20 minutes during the PK Phase. The protocol-defined evening meal will be required to be consumed within 20 minutes. The 5 meal periods will occur on sequential days.
Approximately twenty (20) subjects will be enrolled in order to ensure completion of 16 subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Open-label, randomized, 5-period crossover food effect study
| Arm | Type | Receives |
|---|---|---|
| Breakfast A - Fasting | Other | Drug: Oral Testosterone UndecanoateOral Testosterone Undecanoate 237 mg administered twice daily immediately prior to Fasting at breakfast and immediately prior to dinner. |
| Breakfast B - 15 g fat | Other | Drug: Oral Testosterone UndecanoateOral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 15 g fat breakfast and immediately prior to dinner. |
| Breakfast C - 30 g fat | Other | Drug: Oral Testosterone UndecanoateOral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 30 g fat breakfast and immediately prior to dinner. |
| Breakfast D - 45 g fat | Other | Drug: Oral Testosterone UndecanoateOral Testosterone Undecanoate 237 mg administered twice daily immediately prior to 45 g fat breakfast and immediately prior to dinner. |
| Breakfast E - High Fat | Other | Drug: Oral Testosterone UndecanoateOral Testosterone Undecanoate 237 mg administered twice daily immediately prior to high fat breakfast and immediately prior to dinner. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Man 18 to 65 years of age, inclusive, with a clinical diagnosis of hypogonadism (signs/symptoms consistent with hypogonadism for testosterone naïve subjects and history of signs/symptoms for subjects who have received prior treatment) as well as testosterone levels consistent with hypogonadism as defined by 2 morning total T values of <300 ng/dL (between 6:00 and 10:00 AM drawn on 2 separate days [approximately 7 (±2) days apart].
- Adequate venous access in the left or right arm to allow collection of a number of blood samples via a venous cannula.
- Must be naïve to androgen-replacement therapy or washed out of prior androgen replacement therapies; that is, be willing to cease current T treatment or currently not be taking T treatment, (washout durations specified in exclusion criterion #1). Subjects must remain off all forms of T, except for dispensed study drug, throughout the entire study.
- Subjects on replacement therapy for hypopituitarism or multiple endocrine deficiencies must be on stable doses of thyroid hormone and adrenal replacement hormones for at least 14 days before Screen 1.
- Has voluntarily given written informed consent to participate in this study.
Key exclusion criteria (24 listed)
- Received oral topical (eg, gel or patch), intranasal, or buccal T therapy within the previous 2 weeks, intramuscular T injection of short-acting duration (eg, T enanthate, T cypionate) within the previous 4 weeks, intramuscular T injection of long-acting duration (eg, AVEED) within the previous 20 weeks, or T implantable pellets (Testopel®) within the previous 6 months.
- Has an intercurrent disease deemed clinically significant in the opinion of the investigator of any type; in particular, liver, kidney, uncontrolled or poorly controlled heart disease, including hypertension, congestive heart failure or coronary heart disease, or psychiatric-illness, including severe depression.
- Has had a recent (within 2 years) history of stroke, transient ischemic attack, or acute coronary event.
- Has a mean of the triplicate assessment of sBP > 150 mm Hg and/or dBP > 90 mm Hg at screening (if prescribed antihypertensives, subject should be taking medications on the day of the screening visit with a sip of water). Subjects < 60 years of age and prescribed antihypertensives will be excluded if the mean of the triplicate assessment of sBP > 140 mm Hg and/or dBP > 90 mm Hg at screening.
- Has had recent (within 2 years) history of angina or stent (coronary or carotid) placement.
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 |
|---|---|---|
| Oral Testosterone UndecanoateAll study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods | Drug | Breakfast A - Fasting, Breakfast B - 15 g fat, Breakfast C - 30 g fat, Breakfast D - 45 g fat, Breakfast E - High Fat |
Primary outcome
Cmax-am for Oral TU Across Breakfast With Varying Fat Content
Time frame: 0, 1, 2, 3, 4, 6, 8, 12 hours post-dose
Peak Concentration after morning dose (Cmax) for oral testosterone undecanoate taken after a fasting breakfast of varying fat content.
Time of Peak Concentration (Tmax-am)
Time frame: 12 hours
The time of peak concentration (Tmax-am) will be assessed within each relevant dosing interval.
Area Under the Curve (AUC-am)
Time frame: 0, 1, 2, 3, 4, 6, 8, 12 hours post-dose
The 12 hours following morning dose area under the curve (AUC) will assessed for each sequence of breakfasts with varying fat content.
Time Weighted Average Total Testosterone Concentration (Cavg-am)
Time frame: 12 hours
The time weighted average of total testosterone concentration will be assessed for each dosing interval.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ronald Swerdloff principal investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Testosterone Undecanoate in people with Hypogonadism, run by Clarus Therapeutics, Inc. at 2 sites 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 5 inclusion and 24 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 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 12 Apr 2018). 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?
Cmax-am for Oral TU Across Breakfast With Varying Fat Content (time frame: 0, 1, 2, 3, 4, 6, 8, 12 hours post-dose). The study lists 4 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 17 May 2018.