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DITEST

Phase 1

Male Hypogonadism | Small molecule | Endocrine |Neurocrine Biosciences, Inc.|Last Updated: Nov 26, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02966652Study to Compare DITEST to Testosterone Undecanoate in Adult Men With HypogonadismPHASE1 COMPLETED 25 — — Nov 3, 2016Oct 4, 2018Nov 26, 20191 United Kingdom
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Study Endpoints
Primary Endpoints
Testosterone serum concentrations - Peak Plasma Concentration (Cmax)
Study day 0 to Study Day >7 (sampling time points at -0.5, 0.25 [120mg and TU arms only], 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8 and 10 hours post-Investigational Medicinal Product (IMP) administration, on each visit date)

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 - Area under the serum testosterone concentration-time curve from time 0-10 (AUC(0-10))
Study day 0 to Study Day >7 (sampling time points at -0.5, 0.25 [120mg and TU arms only], 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8 and 10 hours post-IMP administration, on each visit date)

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.

Secondary Endpoints
Testosterone serum concentrations - Peak serum testosterone Concentration (Cmax)
Study day 0 to Study Day >7 (sampling time points at -0.5, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8 and 10 hours post-IMP administration, on each visit date)
Testosterone serum concentrations after 200mg dose - Area under the serum testosterone concentration-time curve (AUC 0-10)
Study day 0 to Study Day >7 (sampling time points at -0.5, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8 and 10 hours post-IMP administration, on each visit date)
Adverse events
Through study completion - a maximum of 84 days.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Testosterone undecanoateACTIVE_COMPARATORCohort 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.
DITESTEXPERIMENTALCohort 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.
Interventions
NameTypeDescription
DITESTDRUGLipid formulation of native oral testosterone.
Testosterone undecanoateDRUGGeneric treatment for patients with primary or secondary male hypogonadism
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Eligibility Criteria
Age Range18 Years — 80 Years
SexMALE
Healthy VolunteersNo
Study Sites1

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...

Countries:United Kingdom
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