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TerminatedNCT03335254Updated May 16, 2019Results posted

A Phase 1/2a Study to Determine the Dose Response Pharmacokinetics of TSX-011 (Testosterone Undecanoate) in Hypogonadal Males

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

Why this study was terminated
Incomplete effect
Phase
Phase 1/2
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Male
01

Study summary

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.
Read the detailed description

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.

02

Conditions studied

  • Hypogonadism
  • Hypogonadism, Male
  • Gonadal Disorders
  • Endocrine System Diseases
  • Testosterone Deficiency

Keywords

  • Hypogonadism
  • Testosterone
  • Testosterone undecanoate
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Testosterone level \<350 ng/dL, 10 am [± 2 hour] sample.
  • Body mass index (BMI) \<35.0 kg/m2 and weight ≥50 kg

Exclusion criteria

Exclusion Criteria:

  • History of clinically significant renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition.
  • Significant gastrointestinal or malabsorption conditions.

  • Any man in whom testosterone therapy is contraindicated including the following:

    1. Known or suspected carcinoma (or history of carcinoma) of the prostate, clinically significant symptoms of benign prostatic hyperplasia, and/or clinically significant symptoms of lower urinary obstruction and International Prostate Symptom Score (IPSS) ≥19. A clinically significant digital rectal examination of the prostate or clinically significant elevated serum PSA levels (>4.0 ng/mL).
    2. Known or suspected carcinoma (or history of carcinoma) of the breast.
    3. Liver disease defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × upper limit of normal (ULN) or bilirubin >2 × ULN.
    4. Active deep vein thrombosis or thromboembolic disorder, or a documented history of these conditions.
    5. Untreated sleep apnea.
    6. Hematocrit >50%.
    7. Untreated moderate to severe depression.
  • Current use of long-acting testosterone or any of the testosterone esters injectables.
  • Topical, oral, or injectable testosterone replacement therapy.
  • Clinically significant changes in any medications (including dosages) or medical conditions in the 28 days before screening.
  • Suspected reversible hypogonadism (e.g., leuprolide injection).
  • Taking concomitant medications that affect testosterone concentrations or metabolism
  • Uncontrolled diabetes (screening glycated hemoglobin [HbA1c] ≥9%).
  • Donated blood or blood products or experienced significant blood loss within 90 days before dosing.
  • Donated bone marrow within 6 months before dosing.
  • History of drug or alcohol abuse in the last 6 months.
  • Ingested St John's wort within 30 days of screening.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Dose-Escalating Arm 1

    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

  • Experimental
    Dose-Escalating Arm 2

    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

  • Experimental
    Dose-Escalating Arm 3

    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

  • Experimental
    Dose-Escalating Arm 4

    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

  • Experimental
    Dose-Escalating Arm 5

    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

  • Experimental
    Dose-Escalating Arm 6

    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

  • Experimental
    Dose-Escalating Arm 7

    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

  • Experimental
    Dose-Escalating Arm 8

    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

  • Experimental
    Dose-Escalating Arm 9

    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

  • Experimental
    Dose-Escalating Arm 10

    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

  • Experimental
    Dose-Escalating Arm 11

    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

  • Experimental
    Dose-Escalating Arm 12

    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

  • Experimental
    Dose-Escalating Arm 13

    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

  • Experimental
    Dose-Escalating Arm 14

    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

  • Experimental
    Dose-Escalating Arm 15

    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

  • Experimental
    Dose-Escalating Arm 16

    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

  • Experimental
    Dose-Escalating Arm 17

    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

  • Experimental
    Dose-Escalating Arm 18

    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

  • Experimental
    Dose-Escalating Arm 19

    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

  • Experimental
    Dose-Escalating Arm 20

    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

Interventions

  • DrugTSX-011

    TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

05

What researchers measure

Primary outcomes

  1. 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.

06

Results

Posted May 16, 2019

Participant flow

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.

Period 1
Participant flow — Period 1
MilestoneDose-Escalating Arm 1Dose-Escalating Arm 2Dose-Escalating Arm 3Dose-Escalating Arm 4Dose-Escalating Arm 5Dose-Escalating Arm 6Dose-Escalating Arm 7Dose-Escalating Arm 8Dose-Escalating Arm 9Dose-Escalating Arm 10Dose-Escalating Arm 11Dose-Escalating Arm 12Dose-Escalating Arm 13Dose-Escalating Arm 14Dose-Escalating Arm 15Dose-Escalating Arm 16Dose-Escalating Arm 17Dose-Escalating Arm 18Dose-Escalating Arm 19Dose-Escalating Arm 20
Started90000000000000000000
Completed90000000000000000000
Not completed00000000000000000000
Period 2, Day 1-15
Participant flow — Period 2, Day 1-15
MilestoneDose-Escalating Arm 1Dose-Escalating Arm 2Dose-Escalating Arm 3Dose-Escalating Arm 4Dose-Escalating Arm 5Dose-Escalating Arm 6Dose-Escalating Arm 7Dose-Escalating Arm 8Dose-Escalating Arm 9Dose-Escalating Arm 10Dose-Escalating Arm 11Dose-Escalating Arm 12Dose-Escalating Arm 13Dose-Escalating Arm 14Dose-Escalating Arm 15Dose-Escalating Arm 16Dose-Escalating Arm 17Dose-Escalating Arm 18Dose-Escalating Arm 19Dose-Escalating Arm 20
Started90000000000000000000
Completed90000000000000000000
Not completed00000000000000000000
Period 3, Day 16-25
Participant flow — Period 3, Day 16-25
MilestoneDose-Escalating Arm 1Dose-Escalating Arm 2Dose-Escalating Arm 3Dose-Escalating Arm 4Dose-Escalating Arm 5Dose-Escalating Arm 6Dose-Escalating Arm 7Dose-Escalating Arm 8Dose-Escalating Arm 9Dose-Escalating Arm 10Dose-Escalating Arm 11Dose-Escalating Arm 12Dose-Escalating Arm 13Dose-Escalating Arm 14Dose-Escalating Arm 15Dose-Escalating Arm 16Dose-Escalating Arm 17Dose-Escalating Arm 18Dose-Escalating Arm 19Dose-Escalating Arm 20
Started90000000000000000000
Completed90000000000000000000
Not completed00000000000000000000
Period 3, Day 26-30
Participant flow — Period 3, Day 26-30
MilestoneDose-Escalating Arm 1Dose-Escalating Arm 2Dose-Escalating Arm 3Dose-Escalating Arm 4Dose-Escalating Arm 5Dose-Escalating Arm 6Dose-Escalating Arm 7Dose-Escalating Arm 8Dose-Escalating Arm 9Dose-Escalating Arm 10Dose-Escalating Arm 11Dose-Escalating Arm 12Dose-Escalating Arm 13Dose-Escalating Arm 14Dose-Escalating Arm 15Dose-Escalating Arm 16Dose-Escalating Arm 17Dose-Escalating Arm 18Dose-Escalating Arm 19Dose-Escalating Arm 20
Started90000000000000000000
Completed90000000000000000000
Not completed00000000000000000000

Outcome measures

PrimaryPercentage 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.
Reported as:
Number · percentage of participants
Percentage of Responders Based on Measured Total Testosterone (Cavg).
percentage of participantsDose-Escalating Arm 1Dose-Escalating Arm 2Dose-Escalating Arm 3Dose-Escalating Arm 4Dose-Escalating Arm 5Dose-Escalating Arm 6Dose-Escalating Arm 7Dose-Escalating Arm 8Dose-Escalating Arm 9Dose-Escalating Arm 10Dose-Escalating Arm 11Dose-Escalating Arm 12Dose-Escalating Arm 13Dose-Escalating Arm 14Dose-Escalating Arm 15Dose-Escalating Arm 16Dose-Escalating Arm 17Dose-Escalating Arm 18Dose-Escalating Arm 19Dose-Escalating Arm 20
Period 133.33———————————————————
Period 222.22———————————————————
Period 3, Day 15-260———————————————————
Period 3, Day 26-300———————————————————

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
Period 1: Single Dose0/9 (0%)0/9 (0%)2/9 (22.2%)
Period 2: Twice Daily Dose0/9 (0%)0/9 (0%)1/9 (11.1%)
Period 3, Day 16-25: Once Daily Dose———
Period 3, Day 16-25: Twice Daily Dose0/9 (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 Dose0/9 (0%)0/9 (0%)2/9 (22.2%)
Most frequent other events
Most frequent other events
EventPeriod 1: Single DosePeriod 2: Twice Daily DosePeriod 3, Day 16-25: Once Daily DosePeriod 3, Day 16-25: Twice Daily DosePeriod 3, Day 26-30: Once Daily DosePeriod 3, Day 26-30: Twice Daily DosePeriod 3, Day 26-30: Thrice Daily Dose
FatigueGeneral disorders0/90/9—0/9——2/9
Insect Bite/Arthropod BiteInjury, poisoning and procedural complications1/90/9—0/9——0/9
Lightheaded/DizzinessNervous system disorders0/90/9—0/9——1/9
Eye IrritationEye disorders0/90/9—0/9——1/9
RhinorrheaRespiratory, thoracic and mediastinal disorders0/91/9—0/9——0/9
CoughRespiratory, thoracic and mediastinal disorders0/91/9—0/9——0/9
SneezingRespiratory, thoracic and mediastinal disorders0/91/9—0/9——0/9
HeadacheNervous system disorders1/91/9—0/9——0/9
Fever/PyrexiaGeneral disorders0/91/9—0/9——0/9
Aphthous UlcerGastrointestinal disorders1/90/9—0/9——0/9

Baseline characteristics

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
Age, Categorical(Participants)Dose-Escalating Arm 1Dose-Escalating Arm 2Dose-Escalating Arm 3Dose-Escalating Arm 4Dose-Escalating Arm 5Dose-Escalating Arm 6Dose-Escalating Arm 7Dose-Escalating Arm 8Dose-Escalating Arm 9Dose-Escalating Arm 10Dose-Escalating Arm 11Dose-Escalating Arm 12Dose-Escalating Arm 13Dose-Escalating Arm 14Dose-Escalating Arm 15Dose-Escalating Arm 16Dose-Escalating Arm 17Dose-Escalating Arm 18Dose-Escalating Arm 19Dose-Escalating Arm 20Total
<=18 years0———————————————————0
Between 18 and 65 years9———————————————————9
>=65 years0———————————————————0
Age, Continuous
Age, Continuous(yr)Dose-Escalating Arm 1Dose-Escalating Arm 2Dose-Escalating Arm 3Dose-Escalating Arm 4Dose-Escalating Arm 5Dose-Escalating Arm 6Dose-Escalating Arm 7Dose-Escalating Arm 8Dose-Escalating Arm 9Dose-Escalating Arm 10Dose-Escalating Arm 11Dose-Escalating Arm 12Dose-Escalating Arm 13Dose-Escalating Arm 14Dose-Escalating Arm 15Dose-Escalating Arm 16Dose-Escalating Arm 17Dose-Escalating Arm 18Dose-Escalating Arm 19Dose-Escalating Arm 20Total
Mean51.9 ± 6.66———————————————————51.9 ± 6.66
Sex: Female, Male
Sex: Female, Male(Participants)Dose-Escalating Arm 1Dose-Escalating Arm 2Dose-Escalating Arm 3Dose-Escalating Arm 4Dose-Escalating Arm 5Dose-Escalating Arm 6Dose-Escalating Arm 7Dose-Escalating Arm 8Dose-Escalating Arm 9Dose-Escalating Arm 10Dose-Escalating Arm 11Dose-Escalating Arm 12Dose-Escalating Arm 13Dose-Escalating Arm 14Dose-Escalating Arm 15Dose-Escalating Arm 16Dose-Escalating Arm 17Dose-Escalating Arm 18Dose-Escalating Arm 19Dose-Escalating Arm 20Total
Female0———————————————————0
Male9———————————————————9
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Dose-Escalating Arm 1Dose-Escalating Arm 2Dose-Escalating Arm 3Dose-Escalating Arm 4Dose-Escalating Arm 5Dose-Escalating Arm 6Dose-Escalating Arm 7Dose-Escalating Arm 8Dose-Escalating Arm 9Dose-Escalating Arm 10Dose-Escalating Arm 11Dose-Escalating Arm 12Dose-Escalating Arm 13Dose-Escalating Arm 14Dose-Escalating Arm 15Dose-Escalating Arm 16Dose-Escalating Arm 17Dose-Escalating Arm 18Dose-Escalating Arm 19Dose-Escalating Arm 20Total
American Indian or Alaska Native0———————————————————0
Asian4———————————————————4
Native Hawaiian or Other Pacific Islander0———————————————————0
Black or African American1———————————————————1
White4———————————————————4
More than one race0———————————————————0
Unknown or Not Reported0———————————————————0
Region of Enrollment
Region of Enrollment(participants)Dose-Escalating Arm 1Dose-Escalating Arm 2Dose-Escalating Arm 3Dose-Escalating Arm 4Dose-Escalating Arm 5Dose-Escalating Arm 6Dose-Escalating Arm 7Dose-Escalating Arm 8Dose-Escalating Arm 9Dose-Escalating Arm 10Dose-Escalating Arm 11Dose-Escalating Arm 12Dose-Escalating Arm 13Dose-Escalating Arm 14Dose-Escalating Arm 15Dose-Escalating Arm 16Dose-Escalating Arm 17Dose-Escalating Arm 18Dose-Escalating Arm 19Dose-Escalating Arm 20Total
United States9———————————————————9
07

Study locations

1 site
  • California Clinical Trials
    Glendale, California 91206, United States
08

References and documents

Study documents

  • Study protocol · Mar 5, 2018
  • Statistical analysis plan · Jun 13, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03335254
Lead sponsor
TesoRx Pharma, LLC
Responsible party
Sponsor
First posted
Nov 7, 2017
Start date
Nov 6, 2017
Primary completion
May 3, 2018
Completion
May 3, 2018
Results posted
May 16, 2019
Last update
May 16, 2019

Study contacts

Michael Oefelein, MD
study director · TesoRx Pharma

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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Discussion

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