drugset / Trial / NCT03335254
A Phase 1/2a Study to Determine the Dose Response Pharmacokinetics of TSX-011 (Testosterone Undecanoate) in Hypogonadal Males
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2017-11-06
- Primary completion
- 2018-05-03
- Completion
- 2018-05-03
Outcome
Outcome not reported
Stopped: “Incomplete effect”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Testosterone Undecanoate | Small molecule | 190 mg | — |
| Subject | Testosterone Undecanoate | Small molecule | 253 mg | — |
| Subject | Testosterone Undecanoate | Small molecule | 317 mg | — |
| Subject | Testosterone Undecanoate | Small molecule | 380 mg | — |
| Subject | Testosterone Undecanoate | Small molecule | 443 mg | — |
| Subject | Testosterone Undecanoate | Small molecule | 507 mg | — |
| Subject | Testosterone Undecanoate | Small molecule | 570 mg | — |
| Subject | Testosterone Undecanoate | Small molecule | 633 mg | — |