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| Name | Class |
|---|---|
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | OTHER |
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The purpose of this pharmacokinetic study is to determine whether oral testosterone (T) ester formulations can be used effectively to treat men with low testosterone.
Determination of the steady-state serum T pharmacokinetic profiles for two oral formulations of T-esters [testosterone undecanoate (TU) and TU combined with testosterone enanthate (TE)] administered bis in die (BID) to 29 hypogonadal adult male subjects. TU was evaluated in total daily doses of 400 and 600 mg equivalents of T given twice daily for 7 or 8 days; TU + TE was evaluated in total daily doses of 600 and 800 mg equivalents of T given twice daily for 7 days. All subjects were enrolled into a single group and proceeded through the four Treatment Periods 1-4 in a sequential manner. In Treatment Period 3 the effect of food on the study-state pharmacokinetics profile of the TU formulation was evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All study participants | Experimental | Treatment Period 1: Three capsules each containing 100 mg testosterone (T) as testosterone undecanoate (TU), twice daily (BID) for 7 days. Treatment Period 2: Two capsules each containing 200 mg T as TU and testosterone enanthate (TE), BID for 7 days. Treatment Period 3: Two capsules each containing 100 mg T as TU, BID for 8 days. Treatment Period 4: Two capsules each containing 150 mg T as TU and TE, BID for 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral testosterone undecanoate (TU) (300 mg T equivalents/dose) | Drug | Three capsules each containing 100 mg testosterone (T) as TU, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Testosterone Average Concentration (Cavg) (ng/dL) | Sampling to determine serum T Cavg post AM and PM doses and for 24 hours in Treatment Periods 1, 2, and 4. Sampling to determine serum T Cavg post AM dose with food (Day 7) and fasting (Day 8) in Treatment Period 3. | 30 minutes pre-dose and 0, 1, 2, 4, 8, 12 hours and 0,1, 2, 4, 8, and 12 hours post respective AM/PM doses |
| Serum Testosterone Area Under Curve (AUC) (0-24) (ng•hr/dL) | Sampling to determine serum T AUC post AM and PM doses and for 24 hours in Treatment Periods 1, 2, and 4. Sampling to determine serum T AUC with food (Day 7) and fasting (Day 8) in Treatment Period 3. | 30 minutes pre-dose and 0, 1, 2, 4, 8, 12 hours and 0,1, 2, 4, 8, and 12 hours post respective AM/PM doses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald S Swerdloff, M.D. | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Principal Investigator |
| Gregory Flippo, M.D. | Alabama Clinical Therapeutics, Inc. | Principal Investigator |
| Steven J. Kulback, M.D. | Alabama Internal Medicine | Principal Investigator |
| Sherwyn Schwartz, M.D. | dgd Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics | Birmingham | Alabama | 35235 | United States | ||
| Alabama Internal Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21474786 | Derived | Yin AY, Htun M, Swerdloff RS, Diaz-Arjonilla M, Dudley RE, Faulkner S, Bross R, Leung A, Baravarian S, Hull L, Longstreth JA, Kulback S, Flippo G, Wang C. Reexamination of pharmacokinetics of oral testosterone undecanoate in hypogonadal men with a new self-emulsifying formulation. J Androl. 2012 Mar-Apr;33(2):190-201. doi: 10.2164/jandrol.111.013169. Epub 2011 Apr 7. |
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After signing an informed consent form, subjects underwent a screening evaluation up to 28 days prior to the first dose of study drug. 29 subjects meeting the admission criteria, began Treatment Period 1 intervention (7 days) followed by a 7-14 day washout period and then proceeded to Treatment Periods 2-4. A 7-14 day washout period occurred between successive Treatment Periods. Treatment Periods 1, 2, and 4 had intervention for 7 days and Treatment Period 3 had intervention for 8 days.
A total of 45 subjects were screened at 4 study sites (1 university medical center and 3 clinical sites). 29 hypogonadal males met all eligibility requirements and were enrolled with first study drug administration on June 13, 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Repeat dose, single-group study including 4 treatment periods with a 7-14 day washout between successive periods: Treatment Period 1: Three capsules each containing 100 mg testosterone (T) as testosterone undecanoate (TU), BID, 30 minutes after initiation of breakfast and dinner meals for 7 days. Treatment Period 2: Two capsules each containing 200 mg T as TU and testosterone enanthate (TE), BID, 30 minutes after initiation of breakfast and dinner meals for 7 days. Treatment Period 3: Two capsules each containing 100 mg T as TU, BID for 8 days except for Day 8 when the morning dose was administered fasting. Treatment Period 4: Two capsules each containing 150 mg T as TU and TE, BID, 30 minutes after initiation of breakfast and dinner meals for 7 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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All subjects were enrolled into a single group and proceeded through the four Treatment Periods 1-4 in a sequential manner.
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| Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (400 mg T equivalents/dose) | Drug | Two capsules each containing 100 mg T as TU and 100 mg T as TE, BID. 400 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods. |
|
| Oral testosterone undecanoate (TU) (200 mg T equivalents/dose with and without food) | Drug | Two capsules each containing 100 mg T as TU, BID for 8 days. 200 mg T equivalents BID 30 minutes after initiation of meals (breakfast and dinner), except for Day 8 when the morning dose was administered fasting. A 7-14 day washout period occurred between successive Treatment Periods. |
|
| Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (300 mg T equivalents/dose) | Drug | Two capsules each containing 150 mg T as TU and 150 mg T as TE, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. |
|
| Birmingham |
| Alabama |
| 35235 |
| United States |
| Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center | Los Angeles | California | 90502 | United States |
| dgd Research, Inc. | San Antonio | Texas | 78229 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment Period 2 |
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| Treatment Period 3 |
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| Treatment Period 4 |
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Data for all 29 subjects enrolled in this single group, four period study are included in the baseline measures at Treatment Period 1. No additional baseline measures were analyzed for successive Treatment Periods 2-4.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Repeat dose, sequential cross-over study including 4 treatment periods with a 7-14 day washout between successive periods: Period 1: Three capsules each containing 100 mg testosterone (T) as testosterone undecanoate (TU), BID, 30 minutes after initiation of breakfast and dinner meals for 7 days. Period 2: Two capsules each containing 200 mg T as TU and testosterone enanthate (TE), BID, 30 minutes after initiation of breakfast and dinner meals for 7 days. Period 3: Two capsules each containing 100 mg T as TU, BID for 8 days except for Day 8 when the morning dose was administered fasting. Period 4: Two capsules each containing 150 mg T as TU and TE, BID, 30 minutes after initiation of breakfast and dinner meals for 7 days. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Total Testosterone (ng/dL) | Mean | Standard Deviation | ng/dL |
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| Body Mass Index (BMI) (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
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| Height | Mean | Standard Deviation | inches |
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| Weight | Mean | Standard Deviation | pounds |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Testosterone Average Concentration (Cavg) (ng/dL) | Sampling to determine serum T Cavg post AM and PM doses and for 24 hours in Treatment Periods 1, 2, and 4. Sampling to determine serum T Cavg post AM dose with food (Day 7) and fasting (Day 8) in Treatment Period 3. | All available individual serum concentrations and pharmacokinetic parameter estimates were reported; missing data were not imputed. For 1 subject in Treatment Period 1 and 1 subject in Treatment Period 4 there were insufficient data to calculate all pharmacokinetic parameters. | Posted | Mean | Standard Deviation | ng/dL | 30 minutes pre-dose and 0, 1, 2, 4, 8, 12 hours and 0,1, 2, 4, 8, and 12 hours post respective AM/PM doses |
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| Primary | Serum Testosterone Area Under Curve (AUC) (0-24) (ng•hr/dL) | Sampling to determine serum T AUC post AM and PM doses and for 24 hours in Treatment Periods 1, 2, and 4. Sampling to determine serum T AUC with food (Day 7) and fasting (Day 8) in Treatment Period 3. | All available individual serum concentrations and pharmacokinetic parameter estimates were reported; missing data were not imputed. For 1 subject in Treatment Period 1 and 1 subject in Treatment Period 4 there were insufficient data to calculate all pharmacokinetic parameters. | Posted | Mean | Standard Deviation | (ng•hr/dL) | 30 minutes pre-dose and 0, 1, 2, 4, 8, 12 hours and 0,1, 2, 4, 8, and 12 hours post respective AM/PM doses |
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Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Study Participants | Single group, repeat dose study including 4 treatment periods (7-8 days) and a 7-14 day washout between successive periods: Treatment Period 1: Three capsules each containing 100 mg testosterone (T) as testosterone undecanoate (TU), BID, 30 minutes after initiation of breakfast and dinner meals for 7 days. Treatment Period 2: Two capsules each containing 200 mg T as TU and testosterone enanthate (TE), BID, 30 minutes after initiation of breakfast and dinner meals for 7 days. Treatment Period 3: Two capsules each containing 100 mg T as TU, BID for 8 days except for Day 8 when the morning dose was administered fasting. Treatment Period 4: Two capsules each containing 150 mg T as TU and TE, BID, 30 minutes after initiation of breakfast and dinner meals for 7 days. The primary purpose of the study was to evaluate the pharmacokinetics of T following short-term, repeat-dose administration of various T doses in the form of TU or as a combination of TU + TE (7-8 days). Consequently, the AEs represent the integrated sum over all of the treatment groups in what was short-term T exposure compared to long-term efficacy and safety evaluations. Due to the short-term exposure to each intervention, changes in laboratory parameters were assessed at the end of the overall study and not the end of each treatment intervention. | 0 | 29 | 1 | 29 | 19 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteomyelitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment | Osteomyelitis, right foot |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Elbow pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Increased AST and ALT | Investigations | MedDRA (10.0) | Systematic Assessment |
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| Emesis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Gastrointestinal reflux | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Hip pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
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| Hunger | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| Vertigo | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Mood altered | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Upper respiratory infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Viral herpes simplex | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Lower back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Nausea and vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. If the communication contains subject matter for which patent protection should be sought, the Sponsor will notify the PI whereupon the PI agrees to grant the Sponsor an additional 60 days to file documents necessary to protect such invention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert E. Dudley, PhD, CEO and President | Clarus Therapeutics, Inc. | 847-562-4300 | rdudley@clarustherapeutics.com |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D005058 | Eunuchism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C010792 | testosterone undecanoate |
| C004648 | testosterone enanthate |
| D005502 | Food |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Cavg (AM dose) with food |
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| Cavg (PM dose) with food |
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| Cavg (AM dose) fasting |
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| OG002 |
| Treatment Period 3 |
Oral testosterone undecanoate (TU) (200 mg T equivalents/dose) with and without food): Two capsules each containing 100 mg T as TU, BID for 8 days 30 minutes after initiation of meals (breakfast and dinner), except for Day 8 when the morning dose was administered fasting. A 7-14 day washout period occurred between successive Treatment Periods. |
| OG003 | Treatment Period 4 | Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (300 mg T equivalents/dose): Two capsules each containing 150 mg T as TU and TE, BID, 30 minutes after initiation of breakfast and dinner meals for 7 days. |
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| Title | Measurements |
|---|---|
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