First human testing of GRT7041 in healthy adults.

A Randomized, Single-center, Double-blind, Placebo-controlled, First-in-human Trial With Single and Multiple Ascending Doses to Determine Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GRT7041 in Healthy Participants.

This trial tests single and repeated doses of GRT7041 in healthy adults to see if it is safe and how the body absorbs and responds to it.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Grünenthal GmbH (industry)
• Locations: 1 site (Christchurch)
• Trial ID: NCT07289776 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, phase 1 interventional trial using single-ascending-dose (SAD) and multiple-ascending-dose (MAD) designs to characterize safety, tolerability, pharmacokinetics, and pharmacodynamics of GRT7041. Part 1 (SAD) includes up to five cohorts with adult males and women of non-childbearing potential, while Part 2 (MAD) includes up to three cohorts of adult males dosed once daily for 14 days. The study also includes a food-effect cohort and a separate assessment of interaction with a CYP3A4 index substrate (midazolam) in MAD cohorts. Participants undergo screening, in-house confinement for dosing and monitoring, and a follow-up/end-of-trial visit at the Christchurch site.

Who should consider this trial

Good fit: Healthy adult volunteers — adult males and women who are not of childbearing potential and who meet screening health criteria — are eligible to participate.

Not a fit: People seeking immediate pain relief or those with cardiac, renal, pancreatic, or coagulation disorders are unlikely to receive therapeutic benefit from this healthy-volunteer trial.

Why it matters

Potential benefit: If results are favorable, the trial could establish safe dosing and support further testing of GRT7041 as a potential new option for treating pain.

How similar studies have performed: This is the first-in-human trial for GRT7041 so there are no prior human data for this compound, although first-in-human PK/PD and safety studies are a standard early step in drug development.

Eligibility criteria

Main Inclusion Criteria:

1. The participant must be able to give signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
2. Participants must sign the ICF before any trial-related assessments.
3. The participant is in good health as judged by the Investigator including medical history, physical examination, 12-lead ECG, vital signs (pulse rate, respiratory rate, systolic and diastolic BP), body temperature, and clinical laboratory parameters (clinical chemistry, hematology, coagulation and urinalysis) without clinically relevant deviations from reference ranges, unless further specified in the exclusion criteria.

Main Exclusion Criteria:

1. History of any of the following: cardiac impairment, renal impairment, pancreatitis, coagulation abnormalities.
2. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk for treatment complications/ participation in the trial unsafe.
3. Any disease or conditions known to interfere with the absorption, distribution, metabolism, or excretion of the IMP.
4. Evidence or medical history of clinically significant and relevant psychiatric issues as assessed by the Investigator.
5. Confirmed or suspected history of clinically relevant drug allergy.
6. Major surgical procedure, within 30 days prior to ICF signing, or anticipation of need for a major surgical procedure during the trial.
7. Blood loss of 500 mL or more (eg, owing to blood donation) within 90 days before Screening Visit.
8. The participant has used any medication, including herbal remedies or over-the-counter medication within 2 weeks (or 5 half-lives, whichever is longer) before the start of the trial intervention or anticipated use during the trial, unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the trial.
9. The participant is enrolled in another clinical trial unless it is an observational (non-interventional) clinical trial or during the follow-up period of an interventional trial) or has received an IMP in another clinical trial within 30 days before Day 1 or within 5 times the elimination half-life of the IMP, whichever is longer.
10. Reluctance to comply with contraception requirements.
11. Evidence or history of alcohol or drug abuse including positive or missing alcohol breath test or drugs of abuse test(s).

Where this trial is running

Christchurch

• New Zealand Clinical Research (NZCR) — Christchurch, New Zealand (RECRUITING)

Study contacts

• Study coordinator: Grünenthal Clinical Trial Helpdesk

Conditions: Treatment of Pain