Conditions: Hypogonadotropic Hypogonadism
Keywords: Drug therapy
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 15
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the effects on serum testosterone after 4 weeks of subcutaneous (SC) dose administration, with different doses and dosing frequencies of TAK-448 to overweight/obese males with hypogonadotropic hypogonadism.

Detailed description:
The drug being tested in this study is called TAK-448. TAK-448 is being tested to treat overweight/obese males with hypogonadotropic hypogonadism. This study will look at the effects of TAK-448 on serum testosterone at different doses and different dosing frequencies.

The study will enroll 15 patients. There will be 5 cohorts and participants will be assigned to cohorts in sequential order. Cohorts will be assigned to the following treatment groups:

* TAK-448 3 µg once weekly
* TAK-448 1 µg once weekly
* TAK-448 0.3 µg once weekly
* TAK-448 0.3 µg twice weekly
* TAK-448 0.1 µg twice weekly

All participants will be administered study drug via SC injection once or twice a week depending on their assigned cohort for four weeks.

This single-center trial will be conducted in the United Kingdom. The overall time to participate in this study is up to 32 days. Participants will make multiple visits to the clinic (depending once-weekly or twice-weekly dosing), and will be contacted by telephone 1 week after last dose of study drug for a follow-up assessment.

Arms:
arm 1: TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22. arm 2: TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22. arm 3: TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22. arm 4: TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25. arm 5: TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.

Interventions: intervention 1: TAK-448
Intervention descriptions: intervention 1: TAK-448 solution for subcutaneous injection

Protocol document: