Phase I pharmacokinetics, safety and tolerability study of DITEST
Research type
Research Study
Full title
A Phase 1, randomised, open-label, 2-cohort, cross-over study to evaluate the pharmacokinetics, safety, and tolerability of a native oral testosterone formulation (DITEST) in the fed and fasted state and compared to testosterone undecanoate in adult men with primary or secondary hypogonadism
IRAS ID
193020
Contact name
Jo Quirke
Contact email
Sponsor organisation
Diurnal Ltd
Eudract number
2015-004255-46
Duration of Study in the UK
0 years, 9 months, 22 days
Research summary
There is an unmet need for an oral testosterone therapy for men with androgen (testosterone) deficiency. Current therapy for most patients in Europe and USA is with either injections or gels. These therapies have the disadvantage of pain with injections, and skin reactions and potential spread to partners with gels. There is one oral formulation of testosterone undecanoate on the market in the UK (Restandol® Testocaps™) but this is not approved in the USA and must be taken with a meal.
DITEST is a novel formulation of testosterone which is being investigated further in this study for its safety and pharmacokinetics (both when given with a meal and when given without) in adult men with testosterone deficiency. The study will be conducted at the Sheffield Royal Hallamshire Hospital in male subjects from 18 to 80 years of age requiring testosterone replacement therapy for primary or secondary hypogonadism (Testosterone deficiency). Subjects will be randomly allocated into two groups of 12 subjects (24 total). In group 1, a single oral dose of 120 mg DITEST and a single oral dose of 80 mg testosterone undecanoate separated by a minimum of a 7-day washout period will be given, with both treatments given after food. In group 2 a single oral dose of 200 mg DITEST (after a meal) and a single oral dose of 200 mg DITEST (after an overnight fast) will be given separated by a minimum of a 7-day washout period. During all treatment periods the subjects will undergo blood and saliva sampling as well as undergoing regular safety assessments including electrocardiograms, vitals signs (Blood pressure, heart rate, temperature) assessments and physical examinations. Total study duration will be approximately 10 months with a maximum estimated duration of approximately 84 days for each individual subject.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0242
Date of REC Opinion
8 Jun 2016
REC opinion
Further Information Favourable Opinion