NCT03102398

A Study to Assess the Safety and Tolerability Profile of TR399 in Healthy Volunteers and Erectile Dysfunction Patients

An Open-Label Phase I/IIa Study to Assess the Safety and Tolerability Profile of TR399 in Healthy Volunteers and Erectile Dysfunction Patients

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Tritech Biopharmaceuticals Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this phase I/IIa study is to assess the safety and tolerability profile of TR399 in healthy volunteers and erectile dysfunction patients. This study will be conducted via a single-arm and open-label fashion.

Detailed description

Several oral medications containing PDE5 inhibitors, including sildenafil (Viagra®, Pfizer), vardenafil (Levitra®, Bayer) and tadalafil (Cialis®, Lilly), have been marketed for the treatment of ED. Many considerations should be taken before patients are prescribed with PDE5 inhibitor medications, which may cause systemic side effects and should not be taken with nitrates or alpha-blockers. The active pharmaceutical ingredient (API) of TR399 is 5% Vardenafil HCl·3H2O. Non-clinical studies have shown that the topical use of TR399 can enhance erection and sexual behavior in animal models without causing irritancy and phototoxicity. This study is designed as a single-arm and open-label fashion in order to explore the safety and PK of TR399 in healthy volunteers, as well as the safety, PK and efficacy of TR399 in patients with ED.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	TR-399 (5% Vardenafil HCl·3H2O, topical gel)	5% Vardenafil HCl·3H2O, topical gel, 2 drops (50ul, 2.5mg), q.d.

Timeline

• Start date: 2017-03-31
• Primary completion: 2018-01-31
• Completion: 2018-03-31
• First posted: 2017-04-05
• Last updated: 2017-11-22

Locations

1 site across 1 country: Taiwan