A Phase 1/2 interventional study of TSX-011 in Hypogonadism, Hypogonadism, Male and Gonadal Disorders, sponsored by TesoRx Pharma, LLC. Terminated at 1 site in United States. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-05-16.
Sponsored by TesoRx Pharma, LLC · Phase 1/2, Interventional, and Treatment
This will be a phase 1/2a, open-label, single-center study with 3 periods. The aims of the study are to:
This will be a phase 1/2a, open-label, single-center study with 3 periods. The aims of the study are to: 1) evaluate the dose-response curve following ascending single doses of TSX-011; 2) confirm optimum dosing conditions; 3) evaluate the efficacy of single or multiple daily adaptive dosing; and 4) evaluate the safety and tolerability of TSX-011. Up to 24 hypogonadal men will be enrolled in this study to yield 16 evaluable subjects, and it is desired that the same 24 subjects participate in all 3 study periods.
Period 1 is an ascending single-dose study of TSX-011 at 3 doses, with the lowest dose administered under fed and fasted conditions: 190 mg TSX-011 in the fed state, 190 mg TSX-011 in the fasted state, 380 mg TSX-011 in the fed state, and 570 mg TSX-011 in the fed state. Before exposure to TSX-011, a 24 hour baseline measurement of testosterone and DHT will be performed for each subject. Samples for analysis of testosterone will be obtained at the following time points on Day -1: hour 0 (8 am ± 60 minutes) and 1.5, 3, 4.5, 6, 8, 12, 16, and 24 hours (± 15 minutes for each time point).
The day following the sampling for endogenous testosterone (Day 1) in Period 1, each subject will receive the first single dose of TSX-011 (190 mg) under fed conditions. Following administration of TSX-011, blood samples will be obtained over a 24-hour period for PK analysis. Subjects will undergo a minimum 3-day and up to 7-day washout period between each of the doses of TSX-011 in Period 1. After the 570 mg TSX 011 dose in Period 1, a minimum 3-day and up to 7-day washout period will occur before the start of Period 2.
Period 2 is a twice-daily dosing period, where fed subjects will be dosed with 380 mg TSX-011 twice daily for 15 days (Days 1 through 15). Pharmacokinetic assessments over 24 hours will occur on Days 1 and 15. The TSX-011 dose will be titrated up or down beginning with the Day 16 (Period 3) morning dose, based on established dosing rules.
Period 3 is a dose-adjusted adaptive design period that begins on Day 16, with the first adjusted TSX-011 dose administered in the fed state on a once-daily or twice-daily schedule. The 6-hour postdose (± 15 minutes) testosterone level on Day 19 will be used to perform the second and final TSX-011 dose adjustment, based on established criteria. As specified by the dose adjustment rules, Day 26 begins with either a once-daily, twice-daily, or thrice-daily fed dose schedule. The thrice-daily dose schedule will be administered only to non-responders. On Day 30, a 24 hour PK assessment will be performed, and the subject's participation in the study is completed the morning of Day 31.
75 studies on the registry are indexed under Eunuchism; 21 are open to participants now.
This study's enrollment of 9 is below the median of 60 across 55 interventional studies indexed under Eunuchism.
Browse Eunuchism studies →TesoRx Pharma, LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.
Compared within Eunuchism, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypogonadism. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any man in whom testosterone therapy is including the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed). Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is \<350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily. Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is \<350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily. Assigned Intervention: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.
Drug: TSX-011
Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed). Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is \<350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily. Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and \<500 ng/dL, adjust dose to 633 mg TU twice daily. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.
Drug: TSX-011
Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed). Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is \<350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily. Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 570 mg (TU) TSX-011 twice daily. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.
Drug: TSX-011
Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed). Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is \<350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily. Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is \>800 ng/dL, decrease to 507 mg TU twice daily. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.
Drug: TSX-011
Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed). Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and \<500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily. Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is \<350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.
Drug: TSX-011
Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed). Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and \<500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily. Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and \<500 ng/dL, adjust dose to 507 mg TU twice daily. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.
Drug: TSX-011
Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed). Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and \<500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily. Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 443 mg (TU) TSX-011 twice daily. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.
Drug: TSX-011
Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed). Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and \<500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily. Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is \>800 ng/dL, decrease dose to 380 mg TU twice daily. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.
Drug: TSX-011
Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed). Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily. Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is \<350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.
Drug: TSX-011
Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed). Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily. Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and \<500 ng/dL, increase dose to 443 mg TU twice daily. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.
Drug: TSX-011
Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed). Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily. Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 380 mg (TU) TSX-011 twice daily. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.
Drug: TSX-011
Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed). Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily. Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is \>800 ng/dL, decrease TSX-011 dose to 317 mg TU twice daily. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.
Drug: TSX-011
Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed). Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is \>800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is \<350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.
Drug: TSX-011
Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed). Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is \>800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily. Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and \<500 ng/dL, increase dose to 380 mg TU twice daily. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.
Drug: TSX-011
Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed). Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is \>800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily. Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 317 mg (TU) TSX-011 twice daily. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.
Drug: TSX-011
Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed). Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is \>800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily. Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is \>800 ng/dL, decrease dose to 253 mg TU twice daily. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.
Drug: TSX-011
Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed). Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is \>800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily. Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is \<350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.
Drug: TSX-011
Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed). Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is \>800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily. Period 3, Day 26-30: Once Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and \<500 ng/dL, dose adjust subjects on once-daily dosing from 507 mg TU daily to 570 mg TU daily. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.
Drug: TSX-011
Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed). Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is \>800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily. Period 3, Day 26-30: Once Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose of 507 mg TU daily. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.
Drug: TSX-011
Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed). Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is \>800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily. Period 3, Day 26-30: Once Daily Dose If Period 3, Day 19 total testosterone is \>800 ng/dL, decrease dose to 380 mg TU daily. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.
Drug: TSX-011
TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.
Percentage of Responders Based on Measured Total Testosterone (Cavg).
TSX-011 responders are defined as study subjects who are able to achieve a Cavg serum total testosterone \> 350 ng/dL. The percentage of responders is recorded for each treatment group within each period.
Time frame: Period 1: Up to 13 days. Period 2: 15 days. Period 3: 15 days.
The trial enrolled nine male subjects. All subjects received treatment and completed the study. None of the enrolled/randomized subjects were withdrawn or discontinued from the study.
| Milestone | Dose-Escalating Arm 1 | Dose-Escalating Arm 2 | Dose-Escalating Arm 3 | Dose-Escalating Arm 4 | Dose-Escalating Arm 5 | Dose-Escalating Arm 6 | Dose-Escalating Arm 7 | Dose-Escalating Arm 8 | Dose-Escalating Arm 9 | Dose-Escalating Arm 10 | Dose-Escalating Arm 11 | Dose-Escalating Arm 12 | Dose-Escalating Arm 13 | Dose-Escalating Arm 14 | Dose-Escalating Arm 15 | Dose-Escalating Arm 16 | Dose-Escalating Arm 17 | Dose-Escalating Arm 18 | Dose-Escalating Arm 19 | Dose-Escalating Arm 20 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Dose-Escalating Arm 1 | Dose-Escalating Arm 2 | Dose-Escalating Arm 3 | Dose-Escalating Arm 4 | Dose-Escalating Arm 5 | Dose-Escalating Arm 6 | Dose-Escalating Arm 7 | Dose-Escalating Arm 8 | Dose-Escalating Arm 9 | Dose-Escalating Arm 10 | Dose-Escalating Arm 11 | Dose-Escalating Arm 12 | Dose-Escalating Arm 13 | Dose-Escalating Arm 14 | Dose-Escalating Arm 15 | Dose-Escalating Arm 16 | Dose-Escalating Arm 17 | Dose-Escalating Arm 18 | Dose-Escalating Arm 19 | Dose-Escalating Arm 20 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Dose-Escalating Arm 1 | Dose-Escalating Arm 2 | Dose-Escalating Arm 3 | Dose-Escalating Arm 4 | Dose-Escalating Arm 5 | Dose-Escalating Arm 6 | Dose-Escalating Arm 7 | Dose-Escalating Arm 8 | Dose-Escalating Arm 9 | Dose-Escalating Arm 10 | Dose-Escalating Arm 11 | Dose-Escalating Arm 12 | Dose-Escalating Arm 13 | Dose-Escalating Arm 14 | Dose-Escalating Arm 15 | Dose-Escalating Arm 16 | Dose-Escalating Arm 17 | Dose-Escalating Arm 18 | Dose-Escalating Arm 19 | Dose-Escalating Arm 20 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Dose-Escalating Arm 1 | Dose-Escalating Arm 2 | Dose-Escalating Arm 3 | Dose-Escalating Arm 4 | Dose-Escalating Arm 5 | Dose-Escalating Arm 6 | Dose-Escalating Arm 7 | Dose-Escalating Arm 8 | Dose-Escalating Arm 9 | Dose-Escalating Arm 10 | Dose-Escalating Arm 11 | Dose-Escalating Arm 12 | Dose-Escalating Arm 13 | Dose-Escalating Arm 14 | Dose-Escalating Arm 15 | Dose-Escalating Arm 16 | Dose-Escalating Arm 17 | Dose-Escalating Arm 18 | Dose-Escalating Arm 19 | Dose-Escalating Arm 20 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
TSX-011 responders are defined as study subjects who are able to achieve a Cavg serum total testosterone \> 350 ng/dL. The percentage of responders is recorded for each treatment group within each period.
| percentage of participants | Dose-Escalating Arm 1 | Dose-Escalating Arm 2 | Dose-Escalating Arm 3 | Dose-Escalating Arm 4 | Dose-Escalating Arm 5 | Dose-Escalating Arm 6 | Dose-Escalating Arm 7 | Dose-Escalating Arm 8 | Dose-Escalating Arm 9 | Dose-Escalating Arm 10 | Dose-Escalating Arm 11 | Dose-Escalating Arm 12 | Dose-Escalating Arm 13 | Dose-Escalating Arm 14 | Dose-Escalating Arm 15 | Dose-Escalating Arm 16 | Dose-Escalating Arm 17 | Dose-Escalating Arm 18 | Dose-Escalating Arm 19 | Dose-Escalating Arm 20 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 | 33.33 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Period 2 | 22.22 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Period 3, Day 15-26 | 0 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Period 3, Day 26-30 | 0 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
Collected over Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Period 1: Single Dose | 0/9 (0%) | 0/9 (0%) | 2/9 (22.2%) |
| Period 2: Twice Daily Dose | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) |
| Period 3, Day 16-25: Once Daily Dose | — | — | — |
| Period 3, Day 16-25: Twice Daily Dose | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Period 3, Day 26-30: Once Daily Dose | — | — | — |
| Period 3, Day 26-30: Twice Daily Dose | — | — | — |
| Period 3, Day 26-30: Thrice Daily Dose | 0/9 (0%) | 0/9 (0%) | 2/9 (22.2%) |
| Event | Period 1: Single Dose | Period 2: Twice Daily Dose | Period 3, Day 16-25: Once Daily Dose | Period 3, Day 16-25: Twice Daily Dose | Period 3, Day 26-30: Once Daily Dose | Period 3, Day 26-30: Twice Daily Dose | Period 3, Day 26-30: Thrice Daily Dose |
|---|---|---|---|---|---|---|---|
| FatigueGeneral disorders | 0/9 | 0/9 | — | 0/9 | — | — | 2/9 |
| Insect Bite/Arthropod BiteInjury, poisoning and procedural complications | 1/9 | 0/9 | — | 0/9 | — | — | 0/9 |
| Lightheaded/DizzinessNervous system disorders | 0/9 | 0/9 | — | 0/9 | — | — | 1/9 |
| Eye IrritationEye disorders | 0/9 | 0/9 | — | 0/9 | — | — | 1/9 |
| RhinorrheaRespiratory, thoracic and mediastinal disorders | 0/9 | 1/9 | — | 0/9 | — | — | 0/9 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/9 | 1/9 | — | 0/9 | — | — | 0/9 |
| SneezingRespiratory, thoracic and mediastinal disorders | 0/9 | 1/9 | — | 0/9 | — | — | 0/9 |
| HeadacheNervous system disorders | 1/9 | 1/9 | — | 0/9 | — | — | 0/9 |
| Fever/PyrexiaGeneral disorders | 0/9 | 1/9 | — | 0/9 | — | — | 0/9 |
| Aphthous UlcerGastrointestinal disorders | 1/9 | 0/9 | — | 0/9 | — | — | 0/9 |
Under the same Period of the trial, only one dosing group was selected based on the adaptive dosing criteria. Therefore, some groups showed zero participants.
| Age, Categorical(Participants) | Dose-Escalating Arm 1 | Dose-Escalating Arm 2 | Dose-Escalating Arm 3 | Dose-Escalating Arm 4 | Dose-Escalating Arm 5 | Dose-Escalating Arm 6 | Dose-Escalating Arm 7 | Dose-Escalating Arm 8 | Dose-Escalating Arm 9 | Dose-Escalating Arm 10 | Dose-Escalating Arm 11 | Dose-Escalating Arm 12 | Dose-Escalating Arm 13 | Dose-Escalating Arm 14 | Dose-Escalating Arm 15 | Dose-Escalating Arm 16 | Dose-Escalating Arm 17 | Dose-Escalating Arm 18 | Dose-Escalating Arm 19 | Dose-Escalating Arm 20 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 0 |
| Between 18 and 65 years | 9 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 9 |
| >=65 years | 0 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 0 |
| Age, Continuous(yr) | Dose-Escalating Arm 1 | Dose-Escalating Arm 2 | Dose-Escalating Arm 3 | Dose-Escalating Arm 4 | Dose-Escalating Arm 5 | Dose-Escalating Arm 6 | Dose-Escalating Arm 7 | Dose-Escalating Arm 8 | Dose-Escalating Arm 9 | Dose-Escalating Arm 10 | Dose-Escalating Arm 11 | Dose-Escalating Arm 12 | Dose-Escalating Arm 13 | Dose-Escalating Arm 14 | Dose-Escalating Arm 15 | Dose-Escalating Arm 16 | Dose-Escalating Arm 17 | Dose-Escalating Arm 18 | Dose-Escalating Arm 19 | Dose-Escalating Arm 20 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 51.9 ± 6.66 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 51.9 ± 6.66 |
| Sex: Female, Male(Participants) | Dose-Escalating Arm 1 | Dose-Escalating Arm 2 | Dose-Escalating Arm 3 | Dose-Escalating Arm 4 | Dose-Escalating Arm 5 | Dose-Escalating Arm 6 | Dose-Escalating Arm 7 | Dose-Escalating Arm 8 | Dose-Escalating Arm 9 | Dose-Escalating Arm 10 | Dose-Escalating Arm 11 | Dose-Escalating Arm 12 | Dose-Escalating Arm 13 | Dose-Escalating Arm 14 | Dose-Escalating Arm 15 | Dose-Escalating Arm 16 | Dose-Escalating Arm 17 | Dose-Escalating Arm 18 | Dose-Escalating Arm 19 | Dose-Escalating Arm 20 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 0 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 0 |
| Male | 9 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 9 |
| Race (NIH/OMB)(Participants) | Dose-Escalating Arm 1 | Dose-Escalating Arm 2 | Dose-Escalating Arm 3 | Dose-Escalating Arm 4 | Dose-Escalating Arm 5 | Dose-Escalating Arm 6 | Dose-Escalating Arm 7 | Dose-Escalating Arm 8 | Dose-Escalating Arm 9 | Dose-Escalating Arm 10 | Dose-Escalating Arm 11 | Dose-Escalating Arm 12 | Dose-Escalating Arm 13 | Dose-Escalating Arm 14 | Dose-Escalating Arm 15 | Dose-Escalating Arm 16 | Dose-Escalating Arm 17 | Dose-Escalating Arm 18 | Dose-Escalating Arm 19 | Dose-Escalating Arm 20 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 0 |
| Asian | 4 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 0 |
| Black or African American | 1 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 1 |
| White | 4 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 4 |
| More than one race | 0 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 0 |
| Unknown or Not Reported | 0 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 0 |
| Region of Enrollment(participants) | Dose-Escalating Arm 1 | Dose-Escalating Arm 2 | Dose-Escalating Arm 3 | Dose-Escalating Arm 4 | Dose-Escalating Arm 5 | Dose-Escalating Arm 6 | Dose-Escalating Arm 7 | Dose-Escalating Arm 8 | Dose-Escalating Arm 9 | Dose-Escalating Arm 10 | Dose-Escalating Arm 11 | Dose-Escalating Arm 12 | Dose-Escalating Arm 13 | Dose-Escalating Arm 14 | Dose-Escalating Arm 15 | Dose-Escalating Arm 16 | Dose-Escalating Arm 17 | Dose-Escalating Arm 18 | Dose-Escalating Arm 19 | Dose-Escalating Arm 20 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States | 9 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 9 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is terminated, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Testosterone undecanoate
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