Treatment of PainPhase 1NCT07289776
A First-in-human Trial of GRT7041 in Healthy Participants
A Phase 1 study testing GRT7041 SAD, Midazolam and GRT7041 MAD in people with Treatment of Pain, run by Grünenthal GmbH at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Treatment of Pain
- What is being tested?
- GRT7041 SAD, Midazolam and GRT7041 MAD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteNew Zealand
- Study dates
- 14 Jan 2026to 28 Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Main Inclusion Criteria:
- 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.
- 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:
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Director Clinical Trials contact
New Zealand1 site, 1 recruiting
- Recruiting
New Zealand Clinical Research (NZCR)
Christchurch, 8011
Cory Sellwood, MD, Cory.sellwood@nzcr.co.nz
Cory Sellwood, MD
About this study
Official title: 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.
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.
Read the 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
- Being tested
- GRT7041 SAD, Placebo, Midazolam, GRT7041 MAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRT7041 SADDrug
Single ascending doses
PlaceboDrug
Placebo to match GRT7041 dose strength
MidazolamDrug
Solution
GRT7041 MADDrug
Multiple ascending doses
| Study group | Role | What they receive |
|---|---|---|
| Part 1: SAD | Experimental | With up to five cohorts SAD1 to SAD5 (n = 40). To be conducted in adult males and WONCBP Receives: 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. Receives: Drug: Placebo; Drug: Midazolam; Drug: GRT7041 MAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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]
The total amount of the study drug (and metabolite) in the blood during the first 24 hours after it is taken.
Assessment of the PK of GRT7041 and its metabolite, GRT1093025, for single-dosing.
Measured: 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]
The total amount of the study drug (and metabolite) in the blood from the time it is taken until the last time a measurable level of the drug is found.
Assessment of the PK of GRT7041 and its metabolite, GRT1093025, for single-dosing.
Measured: 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]
The total amount of the study drug (and metabolite) in the blood from the time it is taken until it has completely left the body.
Assessment of the PK of GRT7041 and its metabolite, GRT1093025, for single-dosing.
Measured: 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]
The maximum amount of the study drug (and metabolite) measured in the blood after taking the dose.
Assessment of the PK of GRT7041 and its metabolite, GRT1093025, for single-dosing.
Measured: 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]
The time it takes to reach the highest concentration of the study drug (and metabolite) in the blood after dosing.
Assessment of the PK of GRT7041 and its metabolite, GRT1093025, for single-dosing.
Measured: 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)
Terminal Elimination Half-Life (t₁/₂) [SAD]
The time it takes for the amount of study drug (and metabolite) in the blood to reduce by half after reaching its peak level.
Assessment of the PK of GRT7041 and its metabolite, GRT1093025, for single-dosing.
Measured: 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)
Terminal Elimination Rate Constant (λz) [SAD]
The rate at which the study drug (and metabolite) is eliminated from the blood during the final phase after dosing.
Assessment of the PK of GRT7041 and its metabolite, GRT1093025, for single-dosing.
Measured: 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)
Apparent Total Clearance of Drug From Plasma After Extravascular Administration (CL/F) [SAD]
The amount of blood completely cleared of thestudy drug (and metabolite) per unit of time, taking into account how much of the drug is absorbed into the body.
Assessment of the PK of GRT7041 and its metabolite, GRT1093025, for single-dosing.
Measured: 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)
Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) [SAD]
An estimate of how widely the study drug spreads through the body's tissues after it is absorbed.
Assessment of the PK of GRT7041 and its metabolite, GRT1093025, for single-dosing.
Measured: 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)
Lag Time Before First Measurable Concentration (tlag) [SAD]
The time between when the study drug (and metabolite) is taken and when it first becomes measurable in the blood.
Assessment of the PK of GRT7041 and its metabolite, GRT1093025, for single-dosing.
Measured: 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 of Last Measurable Concentration (tlast) [SAD]
The last time point when a measurable amount of the study drug (and metabolite) is found in the blood.
Assessment of the PK of GRT7041 and its metabolite, GRT1093025, for single-dosing.
Measured: 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)
Amount of Study Drug Excreted in Urine (Ae) [SAD]
The total amount of the study drug (and metabolite) that is passed out of the body through urine during a specific collection period.
Collected only for one cohort in Part 1: SAD.
Assessment of the PK of GRT7041 and its metabolite, GRT1093025, for single-dosing.
Measured: Day 1 to Day 4 (from 0 hours to 72 hours)
Cumulative Amount of Study Drug Excreted in Urine (Cumulative Ae) [SAD]
The total amount of the study drug (and metabolite) eliminated in urine from the time of dosing up to the end of each collection period, showing how much of the drug has been removed from the body over time.
Collected only for one cohort in Part 1: SAD. Assessment of the PK of GRT7041 and its metabolite, GRT1093025, for single-dosing.
Measured: Day 1 to Day 4 (from 0 hours to 72 hours)
Percentage of Dose Excreted in Urine (Ae%) [SAD].
The percentage of the total amount of the study drug (and metabolite) dose that is passed out in urine during each collection period.
Collected only for one cohort in Part 1: SAD. Assessment of the PK of GRT7041 and its metabolite, GRT1093025, for single-dosing.
Measured: Day 1 to Day 4 (from 0 hours to 72 hours)
Cumulative Percentage of Dose Excreted in Urine (Cumulative Ae%) [SAD]
The total percentage of the study drug dose excreted in urine from dosing until the end of each collection period, showing how much of the drug has been eliminated over time.
Collected only for one cohort in Part 1: SAD. Assessment of the PK of GRT7041 and its metabolite, GRT1093025, for single-dosing.
Measured: Day 1 to Day 4 (from 0 hours to 72 hours)
Renal Clearance of Study Drug (CLr) [SAD]
The rate at which the study drug (and metabolite) is removed from the blood by the kidneys and excreted in the urine.
Collected only for one cohort in Part 1: SAD. Assessment of the PK of GRT7041 and its metabolite, GRT1093025, for single-dosing.
Measured: Day 1 to Day 4 (from 0 hours to 72 hours)
Area Under the Concentration-Time Curve from 0 to 24 hours [(AUC)0-24] [MAD]
Assessment of the pharmacokinetics (PK) of GRT7041 and its metabolite, GRT1093025, for multiple-dosing.
Measured: Day 1 (0 hours - 24 hours)
Maximum Observed Plasma Concentration (Cmax) [MAD]
Assessment of the pharmacokinetics (PK) of GRT7041 and its metabolite, GRT1093025, for multiple-dosing.
Measured: Day 1 (0 hours - 24 hours)
Time to Reach Maximum Observed Plasma Concentration (Tmax) [MAD]
Assessment of the pharmacokinetics (PK) of GRT7041 and its metabolite, GRT1093025, for multiple-dosing.
Measured: Day 1 (0 hours - 24 hours)
Area Under the Plasma Concentration-time Curve Over a Dose Interval at Steady State (AUCτ,ss) [MAD]
Assessment of the pharmacokinetics (PK) of GRT7041 and its metabolite, GRT1093025, for multiple-dosing
Measured: Day 14 - Day 17 (0 hours to 72 hours after last dose) and Day 21
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) [MAD]
Assessment of the pharmacokinetics (PK) of GRT7041 and its metabolite, GRT1093025, for multiple-dosing
Measured: Day 14 - Day 17 (0 hours to 72 hours after last dose) and Day 21
Minimum Observed Plasma Concentration at Steady State (Cmin,ss) [MAD]
Assessment of the pharmacokinetics (PK) of GRT7041 and its metabolite, GRT1093025, for multiple-dosing
Measured: Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, and Day 12 to Day 17 and Day 21
Average Observed Plasma Concentration at Steady State (Cav.ss) [MAD]
Assessment of the pharmacokinetics (PK) of GRT7041 and its metabolite, GRT1093025, for multiple-dosing
Measured: Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, and Day 12 to Day 17 and Day 21
Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State (tmax,ss) [MAD]
Assessment of the pharmacokinetics (PK) of GRT7041 and its metabolite, GRT1093025, for multiple-dosing
Measured: Day 14 - Day 17 (0 hours to 72 hours after last dose) and Day 21
Terminal Elimination Half-Life (t₁/₂) [MAD]
Assessment of the pharmacokinetics (PK) of GRT7041 and its metabolite, GRT1093025, for multiple-dosing
Measured: Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, and Day 12 to Day 17 and Day 21
Terminal Elimination Rate Constant (λz) [MAD]
Assessment of the pharmacokinetics (PK) of GRT7041 and its metabolite, GRT1093025, for multiple-dosing
Measured: Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, and Day 12 to Day 17 and Day 21
Apparent Total Clearance of Drug From Plasma After Extravascular Administration (CL/F) [MAD]
Assessment of the pharmacokinetics (PK) of GRT7041 and its metabolite, GRT1093025, for multiple-dosing
Measured: Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, and Day 12 to Day 17 and Day 21
Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) [MAD]
Assessment of the pharmacokinetics (PK) of GRT7041 and its metabolite, GRT1093025, for multiple-dosing
Measured: Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, and Day 12 to Day 17 and Day 21
Time of Last Measurable Concentration (tlast) [MAD]
Assessment of the pharmacokinetics (PK) of GRT7041 and its metabolite, GRT1093025, for multiple-dosing
Measured: Day 14 - Day 17 (0 hours to 72 hours after last dose) and Day 21
Maximum Observed Plasma Concentration (Cmax) [SAD] for fed and fasted state
Assessment of the effect of food on the PK of GRT7041 following single-dosing
Measured: 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] for fed and fasted state
Assessment of the effect of food on the PK of GRT7041 following single-dosing
Measured: 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] for fed and fasted state
Assessment of the effect of food on the PK of GRT7041 following single-dosing
Measured: 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] of midazolam
PK parameters (AUC0-t, AUC0-inf, Cmax, tmax and t1/2) of midazolam (index substrate) before and after treatment with GRT7041 over 14 days, and when administered alone and after single day and 14 days of treatment with GRT7041
Measured: Day -1, Day 1 and Day 14 (pre-dose, 0.25 hours, 0.5 hours, 1 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours and 18 hours)
Area Under the Plasma Concentration-Time Curve from Time 0 extrapolated to infinity (AUC0-inf ) of midazolam
PK parameters (AUC0-t, AUC0-inf, Cmax, tmax and t1/2) of midazolam (index substrate) before and after treatment with GRT7041 over 14 days, and when administered alone and after single day and 14 days of treatment with GRT7041
Measured: Day -1, Day 1 and Day 14 (pre-dose, 0.25 hours, 0.5 hours, 1 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours and 18 hours)
Maximum Observed Plasma Concentration (Cmax) of midazolam
PK parameters (AUC0-t, AUC0-inf, Cmax, tmax and t1/2) of midazolam (index substrate) before and after treatment with GRT7041 over 14 days, and when administered alone and after single day and 14 days of treatment with GRT7041
Measured: Day -1, Day 1 and Day 14 (pre-dose, 0.25 hours, 0.5 hours, 1 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours and 18 hours)
Time to Reach Maximum Observed Plasma Concentration (Tmax) of midazolam
PK parameters (AUC0-t, AUC0-inf, Cmax, tmax and t1/2) of midazolam (index substrate) before and after treatment with GRT7041 over 14 days
Measured: Day -1, Day 1 and Day 14 (pre-dose, 0.25 hours, 0.5 hours, 1 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours and 18 hours)
Terminal Elimination Half-Life (t₁/₂) of midazolam
PK parameters (AUC0-t, AUC0-inf, Cmax, tmax and t1/2) of midazolam (index substrate) before and after treatment with GRT7041 over 14 days
Measured: Day -1, Day 1 and Day 14 (pre-dose, 0.25 hours, 0.5 hours, 1 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours and 18 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start14 Jan 2026
- Primary completion24 Aug 2026 (estimated)
- Study completion28 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289776
- Sponsor's protocol ID
- HP7041-01
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information available on the Grünenthal Group Web Site (see URL below for details); according to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Data Sharing Principles.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07289776
- Acronym / sponsor ID
- HP7041-01
- Conditions
- Treatment of Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 24 Aug 2026 (estimated)
- Study completion
- 28 Aug 2026 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: SAD | Experimental | Drug: GRT7041 SAD, Drug: PlaceboWith up to five cohorts SAD1 to SAD5 (n = 40). To be conducted in adult males and WONCBP |
| Part 2: MAD | Experimental | Drug: Placebo, Drug: Midazolam, Drug: GRT7041 MADWith 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GRT7041 SADSingle ascending doses | Drug | Part 1: SAD |
| PlaceboPlacebo to match GRT7041 dose strength | Drug | Part 1: SAD, Part 2: MAD |
| MidazolamSolution | Drug | Part 2: MAD |
| GRT7041 MADMultiple ascending doses | Drug | Part 2: MAD |
Primary outcome
Number of participants with Adverse Events
Time frame: Through study completion, an average of 8 Weeks
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
Number of participants with Serious Adverse Events
Time frame: Through study completion, an average of 8 Weeks
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
37 secondary outcomes
Area Under the Concentration-Time Curve from 0 to 24 hours [(AUC)0-24] [SAD]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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)
Terminal Elimination Half-Life (t₁/₂) [SAD]
Time frame: 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)
Terminal Elimination Rate Constant (λz) [SAD]
Time frame: 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)
Apparent Total Clearance of Drug From Plasma After Extravascular Administration (CL/F) [SAD]
Time frame: 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)
Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) [SAD]
Time frame: 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)
Lag Time Before First Measurable Concentration (tlag) [SAD]
Time frame: 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 of Last Measurable Concentration (tlast) [SAD]
Time frame: 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)
Amount of Study Drug Excreted in Urine (Ae) [SAD]
Time frame: Day 1 to Day 4 (from 0 hours to 72 hours)
Cumulative Amount of Study Drug Excreted in Urine (Cumulative Ae) [SAD]
Time frame: Day 1 to Day 4 (from 0 hours to 72 hours)
Percentage of Dose Excreted in Urine (Ae%) [SAD].
Time frame: Day 1 to Day 4 (from 0 hours to 72 hours)
Cumulative Percentage of Dose Excreted in Urine (Cumulative Ae%) [SAD]
Time frame: Day 1 to Day 4 (from 0 hours to 72 hours)
Renal Clearance of Study Drug (CLr) [SAD]
Time frame: Day 1 to Day 4 (from 0 hours to 72 hours)
Area Under the Concentration-Time Curve from 0 to 24 hours [(AUC)0-24] [MAD]
Time frame: Day 1 (0 hours - 24 hours)
Maximum Observed Plasma Concentration (Cmax) [MAD]
Time frame: Day 1 (0 hours - 24 hours)
Time to Reach Maximum Observed Plasma Concentration (Tmax) [MAD]
Time frame: Day 1 (0 hours - 24 hours)
Area Under the Plasma Concentration-time Curve Over a Dose Interval at Steady State (AUCτ,ss) [MAD]
Time frame: Day 14 - Day 17 (0 hours to 72 hours after last dose) and Day 21
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) [MAD]
Time frame: Day 14 - Day 17 (0 hours to 72 hours after last dose) and Day 21
Minimum Observed Plasma Concentration at Steady State (Cmin,ss) [MAD]
Time frame: Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, and Day 12 to Day 17 and Day 21
Average Observed Plasma Concentration at Steady State (Cav.ss) [MAD]
Time frame: Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, and Day 12 to Day 17 and Day 21
Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State (tmax,ss) [MAD]
Time frame: Day 14 - Day 17 (0 hours to 72 hours after last dose) and Day 21
Terminal Elimination Half-Life (t₁/₂) [MAD]
Time frame: Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, and Day 12 to Day 17 and Day 21
Terminal Elimination Rate Constant (λz) [MAD]
Time frame: Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, and Day 12 to Day 17 and Day 21
Apparent Total Clearance of Drug From Plasma After Extravascular Administration (CL/F) [MAD]
Time frame: Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, and Day 12 to Day 17 and Day 21
Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) [MAD]
Time frame: Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, and Day 12 to Day 17 and Day 21
Time of Last Measurable Concentration (tlast) [MAD]
Time frame: Day 14 - Day 17 (0 hours to 72 hours after last dose) and Day 21
Maximum Observed Plasma Concentration (Cmax) [SAD] for fed and fasted state
Time frame: 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] for fed and fasted state
Time frame: 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] for fed and fasted state
Time frame: 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] of midazolam
Time frame: Day -1, Day 1 and Day 14 (pre-dose, 0.25 hours, 0.5 hours, 1 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours and 18 hours)
Area Under the Plasma Concentration-Time Curve from Time 0 extrapolated to infinity (AUC0-inf ) of midazolam
Time frame: Day -1, Day 1 and Day 14 (pre-dose, 0.25 hours, 0.5 hours, 1 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours and 18 hours)
Maximum Observed Plasma Concentration (Cmax) of midazolam
Time frame: Day -1, Day 1 and Day 14 (pre-dose, 0.25 hours, 0.5 hours, 1 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours and 18 hours)
Time to Reach Maximum Observed Plasma Concentration (Tmax) of midazolam
Time frame: Day -1, Day 1 and Day 14 (pre-dose, 0.25 hours, 0.5 hours, 1 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours and 18 hours)
Terminal Elimination Half-Life (t₁/₂) of midazolam
Time frame: Day -1, Day 1 and Day 14 (pre-dose, 0.25 hours, 0.5 hours, 1 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours and 18 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: Yes. Information available on the Grünenthal Group Web Site (see URL below for details); according to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Data Sharing Principles.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Director Clinical Trials contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GRT7041 SAD, Midazolam and GRT7041 MAD in people with Treatment of Pain, run by Grünenthal GmbH at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grünenthal Clinical Trial Helpdesk (+49 241 569 ext. 3223, clinical-trials@grunenthal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (time frame: Through study completion, an average of 8 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.