Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DITEST · 1 trial · 1 indication
Testosterone serum concentrations after administration of a single dose of 120mg or 200mg DITEST and 80mg testosterone undecanoate in the fed state, as measured by the primary PK parameter of Cmax.
Testosterone serum concentrations after administration of a single dose of 120mg or 200mg DITEST and 80mg testosterone undecanoate in the fed state, as measured by the primary PK parameter of AUC.
| Arm | Type | Description |
|---|---|---|
| Testosterone undecanoate | ACTIVE_COMPARATOR | Cohort 1: single dose of 120 mg (3 x 40 mg) DITEST followed by a single dose of 80 mg (2 x 40 mg) testosterone undecanoate or a single dose of 80 mg (2 x 40 mg) testosterone undecanoate followed by single dose of 120 mg (3 x 40 mg) DITEST. The two treatments are separated by a minimum of a 7-day washout period, with both treatments given in the fed state. |
| DITEST | EXPERIMENTAL | Cohort 2: single dose of 200 mg (5 x 40 mg) DITEST (fed) followed by a single dose of 200 mg DITEST (fasted) or a single dose of 200 mg DITEST (fasted) followed by single dose of 200 mg (5 x 40 mg) DITEST (fed). The two treatments are separated by a minimum of a 7-day washout period. |
| Name | Type | Description |
|---|---|---|
| DITEST | DRUG | Lipid formulation of native oral testosterone. |
| Testosterone undecanoate | DRUG | Generic treatment for patients with primary or secondary male hypogonadism |
Inclusion Criteria: * Male subjects aged 18 to 80 years. * Diagnosis of primary testicular failure or secondary hypogonadism due to known pituitary disease or congenital deficit. * Body mass index (BMI) \>18kg/m2 and \<35kg/m2 * Testosterone level \<8nmol/L after washout of current testosterone tre...
DITEST is an investigational small molecule being developed for the treatment of male hypogonadism, a condition in which the body does not produce enough testosterone. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
DITEST is being developed by Neurocrine Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol NBIX. The company is conducting clinical research to evaluate the safety and efficacy of DITEST in men with hypogonadism.
DITEST is in Phase 1 clinical development. One Phase 1 trial has been completed, involving 25 participants. DITEST remains an investigational drug and is not yet approved for commercial use.
DITEST has one completed clinical trial, NCT02966652, titled 'Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism.' This Phase 1 study enrolled 25 adult men in the United Kingdom and was active-controlled, comparing DITEST to an existing testosterone therapy.
No, DITEST is a distinct investigational drug. In clinical trial NCT02966652, DITEST was compared against testosterone undecanoate as an active control, meaning the two are different treatments being evaluated for the same condition, male hypogonadism.