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A Trial to Investigate the Safety and Pharmacokinetics of GRT6019 in Healthy Male Participants
Sponsor: Grünenthal GmbH
Summary
The purpose of this trial is to assess the safety, tolerability, and PK of 3 doses of GRT6019 in healthy male participants. This Phase I trial will be a multiple dose trial in healthy male participants with administration of GRT6019 in 3 cohorts. For each participant, the trial consists of a Screening Period of up to 28 days, a 4 week Treatment Period (including a 2-week clinic stay and 2 weeks in an outpatient setting), and a 5 week Follow-up Period.
Official title: An Open-label, Single-center, 4-week Phase I Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of GRT6019 in Healthy Male Participants
Key Details
Gender
MALE
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-01-06
Completion Date
2026-06
Last Updated
2026-04-09
Healthy Volunteers
Yes
Conditions
Interventions
GRT6019
Multiple dose (MD)
Locations (1)
Biotrial Clinical Pharmacology Unit
Rennes, France