A Study of Parenterally-administered Teverelix TFA in Healthy Male Volunteers
NCT03781947 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2020-03-17
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
Conditions
- Healthy
Interventions
- DRUG
-
teverelix TFA
A single s.c. or i.m. injection of teverelix TFA administered on Day 1
Sponsors & Collaborators
-
Antev Ltd.
lead INDUSTRY
Principal Investigators
-
Pablo Forte Soto, MD · Parexel
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 70 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-11-19
- Primary Completion
- 2020-03-16
- Completion
- 2020-03-16
Countries
- United Kingdom
Study Locations
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