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Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms.
The purpose of this study is to evaluate the pharmacokinetic (PK) parameters of testosterone after administration of TSX-002 (easy to swallow testosterone capsules) to hypogonadal men. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the PK parameters of the testosterone metabolite, dihydrotestosterone (DHT), as well as the safety and tolerability of TSX-002. The study consists of three (3) periods, for which TSX-002 will be taken orally at various doses. Study duration is approximately 9 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1: Single Dose | Experimental | Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2. |
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| Period 2: Two Times Daily Dosing 90 mg | Experimental | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. |
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| Period 3: Two Times Daily Dosing 120 mg | Experimental | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated. Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment. |
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| Period 3: Three Times Daily Dosing 90 mg | Experimental | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated. Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TSX-002 | Drug | TSX-002 are capsules with testosterone as the active ingredient. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders | Percentage of subjects with response to treatment within each period. Response to treatment was considered when Testosterone Cavg was within the physiological range of Testosterone concentration, i.e. 300 - 1050 ng/dL. | Cavg from samples at Period 1: post dose hrs 0,1,2,3,4,5,6,8,12,16,24; Period 2: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 BID: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 TID: hrs 0,2,3,4,5,6,8,10,11,12,13,14,16,18,19,20,21,22,24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irwin Goldstein, MD | San Diego Sexual Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego Sexual Medicine | San Diego | California | 92120 | United States |
Period 1: Each study subject received 5 escalating single doses of TSX-002. Period 2: Each study subject dose was 90 mg BID of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level was drawn and used to determine eligibility for randomization to a further treatment group (BID vs. TID) or continuation in a BID treatment regimen.
The planned enrollment for this study was up to 28 subjects. The actual enrollment of the study was 25 subjects, all of whom were included in the safety and PK evaluable populations. This was a single-center study conducted at San Diego Sexual Medicine medical clinic. First patient screened 27Aug2014, FPE 05Sep2014, LPE 28Jan2015, LPLV 24Apr2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Period 1: Single Dose | Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2. |
| FG001 | Period 2: Two Times Daily Dosing 90 mg | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. |
| FG002 | Period 3: Two Times Daily Dosing 120 mg | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated. Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment. |
| FG003 | Period 3: Three Times Daily Dosing 90 mg | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated. Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment. |
| FG004 | Period 3: Two Times Daily Dosing 180 mg | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated. Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment. |
| FG005 | Period 3: Three Times Daily Dosing 120 mg | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated. Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Single Dose |
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| Period 2: Two Times Daily Dosing 90 mg |
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| Period 3 |
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Subjects that began each defined period.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Study participants start in Period 1 and proceed to Period 2 and then Period 3 Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2. Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment. |
| 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, Categorical | Count of Participants |
| 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 | Percentage of Responders | Percentage of subjects with response to treatment within each period. Response to treatment was considered when Testosterone Cavg was within the physiological range of Testosterone concentration, i.e. 300 - 1050 ng/dL. | Subjects who received TSX-002 and provided PK concentrations for the protocol required 24 hour collection periods. | Posted | Number | percentage of subjects | Cavg from samples at Period 1: post dose hrs 0,1,2,3,4,5,6,8,12,16,24; Period 2: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 BID: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 TID: hrs 0,2,3,4,5,6,8,10,11,12,13,14,16,18,19,20,21,22,24 |
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17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.
Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
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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 | Period 1: Single Dose | Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment | Unrelated to study drug, due to muscle injury due to prolonged muscle compression. Lab abnormalities included acute renal failure secondary to rhabdomyolysis, hyperkalemia, high creatinine kinase, and high level of potassium. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Oefelein, MD, Chief Medical Officer | TesoRx Pharma, LLC | 909-595-0500 | 104 | karl@tesorx.com |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Period 3: Two Times Daily Dosing 180 mg | Experimental | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated. Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment. |
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| Period 3: Three Times Daily Dosing 120 mg | Experimental | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated. Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment. |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Period 2: Two Times Daily Dosing 90 mg | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. |
| OG002 | Period 3: Two Times Daily Dosing 120 mg | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated. Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment. |
| OG003 | Period 3: Three Times Daily Dosing 90 mg | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated. Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment. |
| OG004 | Period 3: Two Times Daily Dosing 180 mg | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated. Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment. |
| OG005 | Period 3: Three Times Daily Dosing 120 mg | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated. Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment. |
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|
| 0 |
| 25 |
| 5 |
| 25 |
| EG001 | Period 2: Two Times Daily Dosing 90 mg | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. | 0 | 21 | 7 | 21 |
| EG002 | Period 3: Two Times Daily Dosing 120 mg | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated. Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment. | 0 | 4 | 1 | 4 |
| EG003 | Period 3: Three Times Daily Dosing 90 mg | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated. Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment. | 0 | 1 | 1 | 1 |
| EG004 | Period 3: Two Times Daily Dosing 180 mg | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated. Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment. | 1 | 8 | 2 | 8 |
| EG005 | Period 3: Three Times Daily Dosing 120 mg | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated. Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment. | 0 | 8 | 2 | 8 |
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| Rhinitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Prostatic specific antigen increased | Investigations | MedDRA (17.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA (17.1) | Systematic Assessment |
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| Blood potassium increased | Investigations | MedDRA (17.1) | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
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| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
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| Testicular pain | Reproductive system and breast disorders | MedDRA (17.1) | Systematic Assessment |
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At 60 days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Site shall provide to Sponsor a copy and allow Sponsor 60 days to review and comment and provide written permission prior to publication.
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |