NCT02369796

A Phase 2a Pharmacodynamic Study of TAK-448 in Participants With Hypogonadotropic Hypogonadism

An Open-Label, Phase 2a Study to Evaluate the Pharmacodynamics of Different Dosing Regimens of TAK-448, a Kisspeptin Agonist, in Male Overweight/Obese Participants With Hypogonadotropic Hypogonadism

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Takeda · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypogonadotropic Hypogonadism

Interventions

Type	Name	Description
DRUG	TAK-448	TAK-448 solution for subcutaneous injection

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-10-01
• Completion: 2015-11-01
• First posted: 2015-02-24
• Last updated: 2017-03-31
• Results posted: 2017-03-31

Locations

1 site across 1 country: United Kingdom