NCT03781947

A Study of Parenterally-administered Teverelix TFA in Healthy Male Volunteers

A Phase I, Open-label, Single Centre Study Investigating the PK, Safety and PD of a Single Dose of Teverelix TFA, a GnRH Antagonist, Via s.c. or i.m. Route of Administration in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Antev Ltd. · Industry
• Sex: Male
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

A Phase I, open-label, single centre study investigating the pharmacokinetics, safety and pharmacodynamics of a single dose of teverelix TFA, a gonadotrophin releasing hormone antagonist, via subcutaneous or intramuscular route of administration in healthy male volunteers

Detailed description

The primary objective of the study is: • To characterise the pharmacokinetic (PK) profile of teverelix following single dose, subcutaneous (s.c.) and intramuscular (i.m.) administration of teverelix TFA in healthy male subjects The secondary objectives of the study are: * To assess the safety and tolerability of teverelix TFA after single s.c. and i.m. injections in healthy male subjects * To evaluate pharmacodynamics (PD) effects of teverelix following single dose, s.c. and i.m. administration of teverelix TFA in healthy male subjects

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	teverelix TFA	A single s.c. or i.m. injection of teverelix TFA administered on Day 1

Timeline

• Start date: 2018-11-19
• Primary completion: 2020-03-16
• Completion: 2020-03-16
• First posted: 2018-12-20
• Last updated: 2020-03-17

Locations

1 site across 1 country: United Kingdom