NCT07289776

A First-in-human Trial of GRT7041 in Healthy Participants

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.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The trial will consist of two parts: * Part 1: SAD with up to five cohorts SAD1 to SAD5 (n = 40). To be conducted in adult males and women of non-childbearing potential (WONCBP). * Part 2: MAD with up to three cohorts, MAD1 to MAD3 (n = 30) dosed once daily (QD) for a period of 14 days. To be conducted in adult males only. The trial design also evaluate the potential interaction of GRT7041 with a CYP3A4 index substrate that will be assessed separately in all cohorts in Part 2 (MAD) of the trial. Dosing in Parts 1 and 2 will be conducted under fasted conditions, except for the SAD3 cohort in Part 1 (SAD), where participants will also receive a standardized breakfast (SAD3b treatment) to assess the effect of food.

Conditions

• Treatment of Pain

Interventions

Type	Name	Description
DRUG	GRT7041 SAD	Single ascending doses
DRUG	Placebo	Placebo to match GRT7041 dose strength
DRUG	Midazolam	Solution
DRUG	GRT7041 MAD	Multiple ascending doses

Timeline

• Start date: 2026-01-14
• Primary completion: 2026-08-24
• Completion: 2026-08-28
• First posted: 2025-12-17
• Last updated: 2026-02-20

Locations

1 site across 1 country: New Zealand