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

Grünenthal

Status and phase: Not yet enrolling; Phase 1

Conditions: Treatment of Pain

Treatments: Drug: GRT7041 SAD; Drug: Midazolam; Drug: GRT7041 MAD; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07289776

HP7041-01

Details and patient eligibility

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

Part 1: SAD

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: GRT7041 SAD

Part 2: MAD

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: GRT7041 MAD

Drug: Midazolam