A First-in-human Trial of GRT7041 in Healthy Participants
ConditionTreatment of Pain
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorGrünenthal GmbH
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
GRT7041 SAD
DrugSingle ascending doses
Placebo
DrugPlacebo to match GRT7041 dose strength
Midazolam
DrugSolution
GRT7041 MAD
DrugMultiple ascending doses
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Part 1: SADExperimental treatment 2 interventions
Group B: Part 2: MADExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
Through study completion, an average of 8 Weeks2
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
Time frame
Through study completion, an average of 8 WeeksSecondary outcomes
1
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.
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)2
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.
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)3
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.
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)4
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.
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)Sponsors and contacts
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Source ClinicalTrials.gov