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ACTIVE NOT RECRUITING
NCT07347548
PHASE1

A Trial to Investigate the Safety and Pharmacokinetics of GRT6019 in Healthy Male Participants

Sponsor: Grünenthal GmbH

View on ClinicalTrials.gov

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

Interventions

DRUG

GRT6019

Multiple dose (MD)

Locations (1)

Biotrial Clinical Pharmacology Unit

Rennes, France