Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
63
Countries
1
Sites
1
Healthy volunteer trial
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Not possible to specify
- Trial duration
- 24 Oct 2023 → 20 Mar 2025
- Decision date (initial)
- 2023-09-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-504538-23-00
- WHO UTN
- U1111-1291-3949
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy volunteer trial
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10053349 | Pharmacokinetic study | 10022891 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Boehringer Ingelheim International GmbH
- Sponsor organisation
- Boehringer Ingelheim International GmbH
- Address
- Binger Strasse 173
- City
- Ingelheim Am Rhein
- Postcode
- 55216
- Country
- Germany
Scientific contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 63 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2023-10-24 | 2025-03-20 | 2023-10-27 | 2025-02-13 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-72621
- Halt date
- 2025-02-13
- Member states concerned
- Belgium
- Publication date
- 2025-02-27
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- One healthy subject on BI 3802876 in study part B had a single hs-cTnT level above the upper limit of normal (<12 ng/L), and exploratory assessments suggest that the hs-cTnT variability within the normal range of hs-cTnT was higher for participants who received BI 3802876 than for those who received placebo. Therefore, Boehringer Ingelheim as the sponsor of this Phase 1 trial, has made the decision to halt all dosing in subjects in this study in order to further investigate, review and discuss the significance of the data and observations.
- Follow-up measures
- As per CTP we will closely monitor safety laboratory, PK in serum, Anti-Drug Antibodies/Neutralizing ADA, TE Biomarkers, Exploratory Safety Biomarkers, 12-lead ECG, vital signs, physical examination, AEs and concomitant medication until the end of the residual effect period for all subjects enrolled so far. For subjects with elevated hs-Troponin T values an echocardiogram as well as an MRI will be requested.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-13 | Belgium | Acceptable 2023-09-25
|
2023-09-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-04 | Belgium | Acceptable 2024-04-23
|
2024-04-23 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-09 | Belgium | Acceptable 2024-08-28
|
2024-08-29 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-13 | Belgium | Acceptable with conditions 2025-03-28
|
2025-03-28 |