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.

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.

Study Overview

• Status: Recruiting
• Conditions: Treatment of Pain
• Intervention / Treatment: Drug: GRT7041 SAD; Drug: Placebo; Drug: Midazolam; Drug: GRT7041 MAD

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Grünenthal Clinical Trial Helpdesk; Phone Number: 3223 +49 241 569; Email: clinical-trials@grunenthal.com
• Study Contact Backup: Name: Director Clinical Trials; Email: clinical-trials@grunenthal.com

Study Locations

• New Zealand
  • Christchurch, New Zealand, 8011
    • Recruiting
    • New Zealand Clinical Research (NZCR)
    • Contact: Cory Sellwood, MD; Email: Cory.sellwood@nzcr.co.nz
    • Principal Investigator: Cory Sellwood, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: SAD; With up to five cohorts SAD1 to SAD5 (n = 40). To be conducted in adult males and WONCBP	Drug: GRT7041 SAD; Single ascending doses; Drug: Placebo; Placebo to match GRT7041 dose strength
Experimental: 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.	Drug: Placebo; Placebo to match GRT7041 dose strength; Drug: Midazolam; Solution; Drug: GRT7041 MAD; Multiple ascending doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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)

Collaborators and Investigators

• Sponsor: Grünenthal GmbH

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2026
• Primary Completion (Estimated): August 24, 2026
• Study Completion (Estimated): August 28, 2026

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzazepines; Benzodiazepines; Midazolam
• Other Study ID Numbers: HP7041-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No