Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABT-SLV361 · 1 trial · 1 indication
Blood sample results for testosterone
| Arm | Type | Description |
|---|---|---|
| Testosterone undecanoate | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ABT-SLV361 | DRUG | For dose groups 1, 2 and 3 medication is taken 1 time per day the first day followed by 2 times per day for 14 days. For dose groups 4 and 5, medication is taken 1 time per day for the first day followed by 2 times per day for 28 days. |
| placebo | DRUG | For dose groups 1, 2 and 3 medication is taken 1 time per day the first day followed by 2 times per day for 14 days. For dose groups 4 and 5, medication is taken 1 time per day for the first day followed by 2 times per day for 28 days. |
Inclusion Criteria 1. Serum total testosterone \< 300 ng/dL based on two blood samples obtained between 6 and 10 AM on two separate occasions at least 48 hours apart. Previously documented total testosterone results obtained within 6 weeks of Study Day -2 may be used during screening for subjects n...
ABT-SLV361 is an investigational small molecule being developed for the treatment of hypogonadal males. It is an endocrine therapy currently in Phase 1 clinical development. The drug is being studied for its safety, tolerability, and pharmacokinetics in this patient population.
ABT-SLV361 is being developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker ABT. The drug is currently in Phase 1 clinical development for hypogonadal males.
ABT-SLV361 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study of the drug has been completed, evaluating its safety, tolerability, and pharmacokinetics in hypogonadal males.
ABT-SLV361 has one completed clinical trial registered as NCT01346319, titled "Study of the Safety, Tolerability and Pharmacokinetics of Testosterone Undecanoate in Hypogonadal Males." This Phase 1 study was a randomized, double-blind, placebo-controlled trial conducted in the United States with male participants aged 18 years and older.
ABT-SLV361 is associated with the compound testosterone undecanoate, as indicated by the clinical trial title for the drug. The Phase 1 study of ABT-SLV361 evaluates testosterone undecanoate in hypogonadal males, suggesting the drug is a form of this testosterone ester.