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

NCT07289776 | Recruiting Phase 1

• 1 other identifier: HP7041-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Treatment of Pain

Outcome Measures

Primary Outcomes (2)

• Number of participants with Adverse Events

  An AE is defined as any unfavorable medical occurrence in a trial participant administered the investigational product. Assessment of the safety and tolerability of GRT7041 after oral single and multiple-dose escalation

  Through study completion, an average of 8 Weeks

• Number of participants with Serious Adverse Events

  A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose: * Results in death, is life-threatening, or requires (or prolongs) hospitalization; * Results in persistent or significant disability/incapacity; * Is a congenital anomaly or birth defect; or * Is considered medically significant, requiring intervention to prevent one of the outcomes above. * Investigator judgment applies to other clinically important events that may not be immediately life-threatening but could jeopardize participant safety. Assessment of the safety and tolerability of GRT7041 after oral single and multiple-dose escalation

  Through study completion, an average of 8 Weeks

Secondary Outcomes (37)

• Area Under the Concentration-Time Curve from 0 to 24 hours [(AUC)0-24] [SAD]

  Day 1 to Day 4 (Pre-dose, 0 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours, 18 hours, 24 hours, 30 hours, 36 hours, 48 hours, 72 hours) and Day 10 (240 hours)

• Area Under the Plasma Concentration-Time Curve from Time 0 to the last measurable concentration (t) [AUC0-t] [SAD]

  Day 1 to Day 4 (Pre-dose, 0 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours, 18 hours, 24 hours, 30 hours, 36 hours, 48 hours, 72 hours) and Day 10 (240 hours)

• Area Under the Plasma Concentration-Time Curve from Time 0 extrapolated to infinity (AUC0-inf ) [SAD]

  Day 1 to Day 4 (Pre-dose, 0 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours, 18 hours, 24 hours, 30 hours, 36 hours, 48 hours, 72 hours) and Day 10 (240 hours)

• Maximum Observed Plasma Concentration (Cmax) [SAD]

  Day 1 to Day 4 (Pre-dose, 0 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours, 18 hours, 24 hours, 30 hours, 36 hours, 48 hours, 72 hours) and Day 10 (240 hours)

• Time to Reach Maximum Observed Plasma Concentration (Tmax) [SAD]

  Day 1 to Day 4 (Pre-dose, 0 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours, 18 hours, 24 hours, 30 hours, 36 hours, 48 hours, 72 hours) and Day 10 (240 hours)

Study Arms (2)

Part 1: SAD

EXPERIMENTAL

With up to five cohorts SAD1 to SAD5 (n = 40). To be conducted in adult males and WONCBP

Drug: GRT7041 SAD; Drug: Placebo

Part 2: MAD

EXPERIMENTAL

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.

Drug: Placebo; Drug: Midazolam; Drug: GRT7041 MAD

Interventions

GRT7041 SAD DRUG

Single ascending doses

Part 1: SAD

Placebo DRUG

Placebo to match GRT7041 dose strength

Part 1: SAD; Part 2: MAD

Midazolam DRUG

Solution

Part 2: MAD

GRT7041 MAD DRUG

Multiple ascending doses

Part 2: MAD

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: The participant is biologically male (both Part 1 and Part 2) or biological female of non-childbearing potential (Part 1 only).
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Participants must sign the ICF before any trial-related assessments.

You may not qualify if:

• History of any of the following: cardiac impairment, renal impairment, pancreatitis, coagulation abnormalities.
• 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.
• Any disease or conditions known to interfere with the absorption, distribution, metabolism, or excretion of the IMP.
• Evidence or medical history of clinically significant and relevant psychiatric issues as assessed by the Investigator.
• Confirmed or suspected history of clinically relevant drug allergy.
• Major surgical procedure, within 30 days prior to ICF signing, or anticipation of need for a major surgical procedure during the trial.
• Blood loss of 500 mL or more (eg, owing to blood donation) within 90 days before Screening Visit.
• 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.
• 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.
• Reluctance to comply with contraception requirements.
• Evidence or history of alcohol or drug abuse including positive or missing alcohol breath test or drugs of abuse test(s).

Sponsors & Collaborators

• Grünenthal GmbH: lead

Study Sites (1)

New Zealand Clinical Research (NZCR)

Christchurch, 8011, New Zealand

RECRUITING

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Grünenthal Clinical Trial Helpdesk

CONTACT

+49 241 569; clinical-trials@grunenthal.com

Director Clinical Trials

CONTACT

clinical-trials@grunenthal.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 17, 2025
• Study Start: January 14, 2026
• Primary Completion (Estimated): August 24, 2026
• Study Completion (Estimated): August 28, 2026
• Last Updated: February 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

NZ (1)