Trial Outcomes & Findings for A Phase 1/2a Study to Determine the Dose Response Pharmacokinetics of TSX-011 (Testosterone Undecanoate) in Hypogonadal Males (NCT NCT03335254)

NCT ID: NCT03335254

Last Updated: 2019-05-16

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 9 participants
• Primary outcome timeframe: Period 1: Up to 13 days. Period 2: 15 days. Period 3: 15 days.
• Results posted on: 2019-05-16

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 None of the enrolled/randomized subjects were withdrawn or discontinued from the study.

Participant milestones

Measure	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. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Period 1 STARTED	9	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period 1 COMPLETED	9	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period 1 NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period 2, Day 1-15 STARTED	9	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period 2, Day 1-15 COMPLETED	9	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period 2, Day 1-15 NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period 3, Day 16-25 STARTED	9	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period 3, Day 16-25 COMPLETED	9	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period 3, Day 16-25 NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period 3, Day 26-30 STARTED	9	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period 3, Day 26-30 COMPLETED	9	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period 3, Day 26-30 NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Dose-Escalating Arm 1 n=9 Participants 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 Dos 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. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	9 Participants n=40 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	0 Participants n=40 Participants
Age, Continuous	51.9 yr STANDARD_DEVIATION 6.66 • n=5 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	51.9 yr STANDARD_DEVIATION 6.66 • n=40 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	0 Participants n=40 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	9 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	0 Participants n=40 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	4 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	1 Participants n=40 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	4 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	0 Participants n=40 Participants
Region of Enrollment United States	9 participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	9 participants n=40 Participants

PRIMARY outcome

Timeframe: Period 1: Up to 13 days. Period 2: 15 days. Period 3: 15 days.

Population: Arm 2 to Arm 20 have zero participants due to dose adjustment based on the total testosterone levels presented.

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.

Outcome measures

Measure	Dose-Escalating Arm 1 n=9 Participants 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. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Percentage of Responders Based on Measured Total Testosterone (Cavg). Period 1	33.33 percentage of participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Percentage of Responders Based on Measured Total Testosterone (Cavg). Period 2	22.22 percentage of participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Percentage of Responders Based on Measured Total Testosterone (Cavg). Period 3, Day 15-26	0 percentage of participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Percentage of Responders Based on Measured Total Testosterone (Cavg). Period 3, Day 26-30	0 percentage of participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Adverse Events

Period 1: Single Dose

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Period 2: Twice Daily Dose

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Period 3, Day 16-25: Once Daily Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Period 3, Day 16-25: Twice Daily Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Period 3, Day 26-30: Once Daily Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Period 3, Day 26-30: Twice Daily Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Period 3, Day 26-30: Thrice Daily Dose

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Period 1: Single Dose n=9 participants at risk Period 1. Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed). TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.	Period 2: Twice Daily Dose n=9 participants at risk 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.	Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is \>800 ng/dL, subjects randomized in a 1:1 ratio to receive: * Schedule A: 317 mg (TU) TSX-011 twice daily OR * Schedule B: 507 mg (TU) TSX-011 once daily. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.	Period 3, Day 16-25: Twice Daily Dose n=9 participants at risk If Period 2 Day 8 total testosterone is \<350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily. 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. If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily. If Period 2 Day 8 total testosterone is \>800 ng/dL, randomize subjects in a 1:1 ratio to receive: * Schedule A: 317 mg (TU) TSX-011 twice daily OR * Schedule B: 507 mg (TU) TSX-011 once daily. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.	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. If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose of 507 mg TU daily. If Period 3, Day 19 total testosterone is \>800 ng/dL, decrease TSX-011 dose as follows: Dose adjust subjects on once-daily dosing from 507 mg TU daily to 380 mg TU daily. TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.	Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and \<500 ng/dL: Dose adjust subjects on twice daily dosing as follows: * If dose is 570 mg TU twice daily, increase to 633 mg TU twice daily. * If dose is 443 mg TU twice daily, increase to 507 mg TU twice daily. * If dose is 380 mg TU twice daily, increase to 443 mg TU twice daily. * If dose is 317 mg TU twice daily, increase to 380 mg TU twice daily. If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose twice daily. If Period 3 Day 19 total testosterone is \>800 ng/dL, decrease TSX-011 dose as follows: For the twice-daily dosing group: * If dose is 570 mg TU twice daily, decrease to 507 mg TU twice daily. * If dose is 443 mg TU twice daily, decrease to 380 mg TU twice daily. * If dose is 380 mg TU twice daily, decrease to 317 mg TU twice daily. * If dose is 317 mg TU twice daily, decrease to 253 mg TU twice daily. TSX-011 are capsules with primarily Testosterone Undecanoate.	Period 3, Day 26-30: Thrice Daily Dose n=9 participants at risk 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.
Injury, poisoning and procedural complications Insect Bite/Arthropod Bite	11.1% 1/9 • Number of events 1 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.
General disorders Fatigue	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	22.2% 2/9 • Number of events 2 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.
Nervous system disorders Lightheaded/Dizziness	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	11.1% 1/9 • Number of events 1 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.
Eye disorders Eye Irritation	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	11.1% 1/9 • Number of events 1 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	11.1% 1/9 • Number of events 1 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	11.1% 1/9 • Number of events 1 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	11.1% 1/9 • Number of events 1 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.
Nervous system disorders Headache	11.1% 1/9 • Number of events 1 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	11.1% 1/9 • Number of events 1 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.
General disorders Fever/Pyrexia	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	11.1% 1/9 • Number of events 1 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.
Gastrointestinal disorders Aphthous Ulcer	11.1% 1/9 • Number of events 1 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	— 0/0 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.	0.00% 0/9 • Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit). An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject's participation in the study. Subjects were asked an open question such as "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.

Additional Information

Michael Oefelein, MD, Chief Medical Officer

TesoRx Pharma, LLC

Phone: 909-595-0500

Email: karl@tesorx.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor will review and provide prior written consent, which shall not be unreasonably withheld. PI will be permitted to publish in journals, theses, dissertations, or other formats of their own choosing.
• Publication restrictions are in place

Restriction type: OTHER