UK-based specialist pharmaceutical company Diurnal has begun its Phase I clinical trial of DITEST to treat males with hypogonadism.
DITEST is an oral formulation comprising native testosterone adapted for oral delivery for the treatment of hypogonadism.
The proprietary lipid-based formulation aims to provide improved bioavailability.
The cause of hypogonadism is attributed to failure of the testes termed as primary gonadal failure or failure of stimulation by the pituitary (secondary hypogonadism) resulting in testosterone insufficiency.
The proof-of-concept, randomised Phase I trial will be conducted to test the pharmacokinetics, safety and tolerability of DITEST in both fed and fasted states compared to testosterone undecanoate, which is an approved oral modified testosterone treatment in 24 adult men with primary or secondary hypogonadism.
The study is primarily focused on comparing the rate and extent of absorption of testosterone from a single dose of DITEST with a single dose of 80mg testosterone undecanoate in the fed state in adult male patients.
The secondary endpoints will test the effect of food on the rate and extent of absorption of testosterone from DITEST and to assess the safety and tolerability of two different doses of DITEST.
The trial is slated to be completed by next year.
Diurnal CEO Dr Martin Whitaker said: “DITEST is our next pipeline product to enter clinical development after Infacort and Chronocort, our lead programmes.
“Currently available topical formulations of native testosterone have significant compliance and potential safety issues while, to date, attempts to create oral preparations of modified testosterone have resulted in products with unacceptable pharmacokinetic variability.
“Therefore, there is an unmet need for an effective oral testosterone treatment for hypogonadism that we believe can be met by our oral proprietary formulation.”