Actively Recruiting
A First-in-human Trial of GRT7041 in Healthy Participants
Led by Grünenthal GmbH · Updated on 2026-02-20
70
Participants Needed
1
Research Sites
32 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this trial is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GRT7041 in healthy male and female (Women of non-childbearing potential) participants. The trial duration will be up to approximately 6 weeks for participants in Part 1 (Single ascending dose \[SAD\]), except for participants taking part in the food effect cohort SAD3 where the trial duration will be up to approximately 8 weeks. The trial duration will be up to approximately 7 weeks in Part 2 (Multiple ascending dose \[MAD\]), and the Treatment Period will be up to 14 days (for Part 2). The trial will include a Screening Visit, an in-house stay period and Follow-up (FU) Visit/End-of-Trial (EoT) Visit.
CONDITIONS
Official Title
A First-in-human Trial of GRT7041 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent and comply with study requirements
- Signed informed consent form before any trial assessments
- In good health based on medical history, physical exam, ECG, vital signs, temperature, and lab tests without relevant abnormalities
You will not qualify if you...
- History of cardiac, renal, or pancreas problems, or blood clotting disorders
- Any disease or lab findings that make investigational drug use unsafe or affect study results
- Conditions affecting drug absorption, metabolism, or elimination
- Significant psychiatric issues
- History of relevant drug allergies
- Major surgery within 30 days before consent or planned during study
- Blood loss of 500 mL or more within 90 days before screening
- Use of any medication including herbal or OTC within 2 weeks before trial unless approved
- Participation in another clinical trial with investigational drugs within 30 days or five elimination half-lives
- Reluctance to follow contraception requirements
- History or evidence of alcohol or drug abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
New Zealand Clinical Research (NZCR)
Christchurch, New Zealand, 8011
Actively Recruiting
Research Team
G
Grünenthal Clinical Trial Helpdesk
CONTACT
D
Director Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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