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Androgen

DITEST for Testicular Hypogonadism

Phase 1
Waitlist Available
Led By J Newell-Price, MA, PhD
Research Sponsored by Diurnal Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

DITEST is an oral formulation of native testosterone for the treatment of androgen deficiency in men. The study was a Phase 1 clinical study in hypogonadal men, defined according to FDA and Endocrine Society Guidelines, designed to evaluate the pharmacokinetic (PK) characteristics of DITEST, and to assess the safety and tolerability of DITEST in the target population.

Eligible Conditions
  • Testicular Hypogonadism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Testosterone serum concentrations - Area under the serum testosterone concentration-time curve from time 0-10 (AUC(0-10))
Testosterone serum concentrations - Peak Plasma Concentration (Cmax)
Secondary study objectives
Adverse events
Electrocardiogram (ECG)
Safety Laboratory Data
+3 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DITESTExperimental Treatment1 Intervention
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.
Group II: Testosterone undecanoateActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DITEST
2016
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Simbec ResearchIndustry Sponsor
40 Previous Clinical Trials
1,973 Total Patients Enrolled
EMAS PharmaIndustry Sponsor
4 Previous Clinical Trials
165 Total Patients Enrolled
CovanceIndustry Sponsor
119 Previous Clinical Trials
12,793 Total Patients Enrolled
~3 spots leftby Oct 2025
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