A Study in Healthy People to Test Whether Different Doses of BI 1015550 Have Potential to Induce Heart Rhythm Abnormalities

Thorough QT Study to Evaluate the Effects of BI 1015550 as Single Doses Following Oral Administration on Cardiac Safety Parameters (Double-blind, Randomized, Placebo-controlled, Five-period Crossover, With Open-label Moxifloxacin as Positive Control) in Healthy Male and Female Subjects

The main objective of this trial is to evaluate the effects of a single therapeutic and a single supra-therapeutic dose of BI 1015550 following oral administration on cardiac safety parameters in healthy male and female volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 1015550; Drug: Moxifloxacin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG11 6JS
    • Quotient Sciences

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs - blood pressure (BP) and pulse rate (PR), 12-lead electrocardiogram (ECG), and clinical laboratory tests without any clinically significant abnormalities
2. Age of 18 to 50 years (inclusive)
3. Body mass index of 18.5 to 32 kg/m^2 (inclusive)
4. Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

5. Either male subjects, or female subjects meet the following criteria requiring highly effective contraception from at least 30 days before the first administration of trial medication until 37 days after the last administration of the study drug:

   • Male participants must use condom plus their partner, if identified as a women of childbearing potential (WOCBP), must use an oral contraceptive or highly effective contraception
   • Female participants must be using highly effective contraception and in addition their male partner must use a condom if they are using an oral contraceptive

Exclusion Criteria:

1. Any finding in the medical examination (including BP, Heart rate (HR) or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or heart rate outside the range of 50 to 90 beats per minute (bpm)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine transaminase, aspartate transaminase, total bilirubin) or renal parameters (creatinine) exceeding the upper limit of normal
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the investigator
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders including but not limited to depression and suicidal behaviour
8. History of clinically relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

15

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1: H/M/P2/L/P1; Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment. H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast. M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control. P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group. L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast. P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.	Drug: BI 1015550; BI 1015550 administered as low (L), and high (H), dose. Oral tablet.; Other Names: Nerandomilast; JASCAYD®; Drug: Moxifloxacin; Moxifloxacin was used as positive control, given as a high dose. Oral tablet.; Other Names: Avelox®; Drug: Placebo; Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Experimental: Sequence 2: H/P1/L/P2/M; Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment. H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast. P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group. L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast. P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group. M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.	Drug: BI 1015550; BI 1015550 administered as low (L), and high (H), dose. Oral tablet.; Other Names: Nerandomilast; JASCAYD®; Drug: Moxifloxacin; Moxifloxacin was used as positive control, given as a high dose. Oral tablet.; Other Names: Avelox®; Drug: Placebo; Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Experimental: Sequence 3: H/L/P2/M/P1; Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment. H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast. L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast. P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group. M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control. P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.	Drug: BI 1015550; BI 1015550 administered as low (L), and high (H), dose. Oral tablet.; Other Names: Nerandomilast; JASCAYD®; Drug: Moxifloxacin; Moxifloxacin was used as positive control, given as a high dose. Oral tablet.; Other Names: Avelox®; Drug: Placebo; Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Experimental: Sequence 4: M/H/L/P1/P2; Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment. M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control. H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast. L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast. P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group. P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.	Drug: BI 1015550; BI 1015550 administered as low (L), and high (H), dose. Oral tablet.; Other Names: Nerandomilast; JASCAYD®; Drug: Moxifloxacin; Moxifloxacin was used as positive control, given as a high dose. Oral tablet.; Other Names: Avelox®; Drug: Placebo; Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Experimental: Sequence 5: M/P1/L/H/P2; Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment. M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control. P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group. L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast. H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast. P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.	Drug: BI 1015550; BI 1015550 administered as low (L), and high (H), dose. Oral tablet.; Other Names: Nerandomilast; JASCAYD®; Drug: Moxifloxacin; Moxifloxacin was used as positive control, given as a high dose. Oral tablet.; Other Names: Avelox®; Drug: Placebo; Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Experimental: Sequence 6: M/P2/H/L/P1; Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment. M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control. P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group. H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast. L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast. P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.	Drug: BI 1015550; BI 1015550 administered as low (L), and high (H), dose. Oral tablet.; Other Names: Nerandomilast; JASCAYD®; Drug: Moxifloxacin; Moxifloxacin was used as positive control, given as a high dose. Oral tablet.; Other Names: Avelox®; Drug: Placebo; Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Experimental: Sequence 7: P1/M/H/P2/L; Participants in this study received five treatments ordered as described below. Each treatment was administered orally with 240 mL of water after an overnight fast of at least 10 hours. Each treatment was separated by a wash-out period of at least 7 days. P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group. M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control. H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast. P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group. L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.	Drug: BI 1015550; BI 1015550 administered as low (L), and high (H), dose. Oral tablet.; Other Names: Nerandomilast; JASCAYD®; Drug: Moxifloxacin; Moxifloxacin was used as positive control, given as a high dose. Oral tablet.; Other Names: Avelox®; Drug: Placebo; Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Experimental: Sequence 8: P1/P2/H/M/L; Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment. P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group. P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group. H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast. M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control. L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.	Drug: BI 1015550; BI 1015550 administered as low (L), and high (H), dose. Oral tablet.; Other Names: Nerandomilast; JASCAYD®; Drug: Moxifloxacin; Moxifloxacin was used as positive control, given as a high dose. Oral tablet.; Other Names: Avelox®; Drug: Placebo; Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Experimental: Sequence 9: P1/L/M/H/P2; Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment. P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group. L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast. M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control. H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast. P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.	Drug: BI 1015550; BI 1015550 administered as low (L), and high (H), dose. Oral tablet.; Other Names: Nerandomilast; JASCAYD®; Drug: Moxifloxacin; Moxifloxacin was used as positive control, given as a high dose. Oral tablet.; Other Names: Avelox®; Drug: Placebo; Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Experimental: Sequence 10: P2/H/P1/M/L; Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment. P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group. H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast. P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group. M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control. L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.	Drug: BI 1015550; BI 1015550 administered as low (L), and high (H), dose. Oral tablet.; Other Names: Nerandomilast; JASCAYD®; Drug: Moxifloxacin; Moxifloxacin was used as positive control, given as a high dose. Oral tablet.; Other Names: Avelox®; Drug: Placebo; Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Experimental: Sequence 11: P2/P1/M/L/H; Participants in this study received five treatments ordered as described below. Each treatment was administered orally with 240 mL of water after an overnight fast of at least 10 hours. Each treatment was separated by a wash-out period of at least 7 days. P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group. P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group. M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control. L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast. H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.	Drug: BI 1015550; BI 1015550 administered as low (L), and high (H), dose. Oral tablet.; Other Names: Nerandomilast; JASCAYD®; Drug: Moxifloxacin; Moxifloxacin was used as positive control, given as a high dose. Oral tablet.; Other Names: Avelox®; Drug: Placebo; Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Experimental: Sequence 12: P2/L/M/P1/H; Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment. P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group. L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast. M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control. P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group. H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.	Drug: BI 1015550; BI 1015550 administered as low (L), and high (H), dose. Oral tablet.; Other Names: Nerandomilast; JASCAYD®; Drug: Moxifloxacin; Moxifloxacin was used as positive control, given as a high dose. Oral tablet.; Other Names: Avelox®; Drug: Placebo; Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Experimental: Sequence 13: L/H/P1/P2/M; Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment. L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast. H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast. P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group. P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group. M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.	Drug: BI 1015550; BI 1015550 administered as low (L), and high (H), dose. Oral tablet.; Other Names: Nerandomilast; JASCAYD®; Drug: Moxifloxacin; Moxifloxacin was used as positive control, given as a high dose. Oral tablet.; Other Names: Avelox®; Drug: Placebo; Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Experimental: Sequence 14: L/M/P2/P1/H; Participants in this study received five treatments ordered as described below. Each treatment was administered orally with 240 mL of water after an overnight fast of at least 10 hours. Each treatment was separated by a wash-out period of at least 7 days. L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast. M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control. P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group. P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group. H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.	Drug: BI 1015550; BI 1015550 administered as low (L), and high (H), dose. Oral tablet.; Other Names: Nerandomilast; JASCAYD®; Drug: Moxifloxacin; Moxifloxacin was used as positive control, given as a high dose. Oral tablet.; Other Names: Avelox®; Drug: Placebo; Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.
Experimental: Sequence 15: L/P2/P1/H/M; Participants in this study received five treatments ordered as described below. Each treatment was administered orally with 240 mL of water after an overnight fast of at least 10 hours. Each treatment was separated by a wash-out period of at least 7 days. L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast. P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group. P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group. H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast. M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.	Drug: BI 1015550; BI 1015550 administered as low (L), and high (H), dose. Oral tablet.; Other Names: Nerandomilast; JASCAYD®; Drug: Moxifloxacin; Moxifloxacin was used as positive control, given as a high dose. Oral tablet.; Other Names: Avelox®; Drug: Placebo; Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Maximum Mean Difference Between Each Single Dose of Either a Low Dose or a High Dose of Nerandomilast and Placebo in QTcF Changes From Baseline Between 20 Min to 24 Hours After Drug Administration	QT interval corrected for heart rate (using the method of Fridericia, QTcF) changes from baseline, measured between 20 minutes and 24 hours after drug administration, were analyzed using a linear Mixed Model for Repeated Measures (MMRM). Pairwise comparison was used to compare the QTcF changes for each dose of nerandomilast (e.g., low dose, high dose) with the placebo at every time point. Mean treatment differences in the QTcF changes from baseline at each time point were estimated by the differences in the corresponding least-squares means. Two-sided 90% confidence intervals based on the t-distribution were computed for each time point. The MMRM was adjusted for the discrete fixed effects treatment, period, time, the continuous fixed effects period- and participant-baseline, the fixed effect-by-time terms, participant as random effect and time within period as a repeated effect per participant. The covariance structure for the repeated effect time was unstructured.	MMRM included measurements at these time points [hours:minutes] post-drug: 0:20, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 12:00, and 24:00. MMRM values at 12:00 (low dose) and 4:30 (high dose) are shown in the table below.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Maximum Mean Difference Between Moxifloxacin and Placebo in QTcF Changes From Baseline Between 20 Min to 24 Hours After Drug Administration.	QT interval corrected for heart rate (using the method of Fridericia, QTcF) changes from baseline, measured between 20 minutes and 24 hours after drug administration, were analyzed using a linear Mixed Model for Repeated Measures (MMRM). Pairwise comparison was used to compare the QTcF changes for moxifloxacin with the placebo at every time point. Mean treatment differences in the QTcF changes from baseline at each time point were estimated by the differences in the corresponding least-squares means. Two-sided 90% confidence intervals based on the t-distribution were computed for each time point. The MMRM was adjusted for the discrete fixed effects treatment, period, time, the continuous fixed effects period- and participant-baseline, the fixed effect-by-time terms, participant as random effect and time within period as a repeated effect per participant. The covariance structure for the repeated effect time was unstructured.	MMRM included measurements at these time points [hours:minutes] post-drug: 0:20, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 12:00, and 24:00. MMRM values at 3:30 (high dose moxifloxacin) are shown in the table below.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2024
• Primary Completion (Actual): July 25, 2024
• Study Completion (Actual): July 25, 2024

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Moxifloxacin; BI 1015550
• Other Study ID Numbers: 1305-0026; U1111-1295-4664 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

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