NCT02966652

Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Neurocrine UK Limited · Industry
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

There is an unmet need for a native oral testosterone therapy for men with androgen (testosterone) deficiency. Ideally such a treatment should have reproducible PK, does not need to be taken with fatty meals, can be taken once or twice daily, and provides physiological exposure to testosterone. This Phase 1, randomised, open-label, 2-cohort, cross-over study was therefore designed to evaluate the PK characteristics of DITEST in both the fed and fasted states according to FDA guidelines, and to assess the safety and tolerability of DITEST in the target population. The study was conducted in male subjects from 18 to 80 years of age requiring testosterone replacement therapy for primary or secondary hypogonadism. The study was a randomised, active control, single dose, 2-way cross-over study in 2 cohorts. In each cohort subjects who meet the entry criteria at screening and baseline were randomised to one of 2 sequences: 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 (TU) or a single dose of 80 mg TU followed by single dose of 120 mg DITEST. The two treatments were separated by a minimum of a 7-day washout period, with both treatments given in the fed state. 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 DITEST (fed). The two treatments were separated by a minimum of a 7-day washout period. 13 subjects were recruited into cohort 1 and 12 subjects were recruited into cohort 2, resulting in a total of 25 subjects being administered study medication in this study. Subjects were not recruited into Cohort 2 until the results of subjects treated in Cohort 1 had been evaluated (this review was to determine if the intended dose for Cohort 2 needed to be adjusted). No other testosterone treatments were allowed for the duration of the study (including the washout periods). Each subject was required to attend the study centre for a minimum of either 4 or 5 visits: a screening assessment, an evaluation of baseline testosterone levels after the washout period from the subject's current medication (only for subjects currently on testosterone replacement therapy), both dosing days, and a follow-up visit at the end of the study.

Conditions

• Male Hypogonadism

Interventions

Type	Name	Description
DRUG	DITEST	Lipid formulation of native oral testosterone.
DRUG	Testosterone undecanoate	Generic treatment for patients with primary or secondary male hypogonadism

Timeline

• Start date: 2016-11-03
• Primary completion: 2018-10-04
• Completion: 2018-10-04
• First posted: 2016-11-17
• Last updated: 2019-11-26

Locations

1 site across 1 country: United Kingdom