Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
60
Countries
1
Sites
1
Healthy
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 19 Jun 2023 → 6 Jun 2024
- Decision date (initial)
- 2023-05-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy
| 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 | 60 | 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 | 2023-06-19 | 2024-06-06 | 2023-06-23 | 2024-04-30 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-4196
- Halt date
- 2023-08-18
- Member states concerned
- Belgium
- Publication date
- 2023-08-25
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- In the second dose group (150 mg BID) all 8 subjects receiving BI 1815368 have showed increased serum creatinine (up to a max of 1.44 mg/dl (normal range 0.67 – 1.17 mg/dl) and decrease estimated glomerular filtration rate (GFR) (based on creatinine). Other routine labs were normal. The sponsor instructed the site to stop further dosing to all subjects in the trial until the relevance of the above-mentioned findings can be fully evaluated, and appropriate monitoring can be established.
- Follow-up measures
- All subjects have been tested for additional parameters to evaluate renal function which include cystatin c, urea and urinalyses.
As of 21st of August all subjects remained asymptomatic and levels of creatinine are improving after drug discontinuation. Additional investigations of renal function (urea and urinalysis) remained within normal limits. Results of Cystatin-C are still pending. - Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-05 | Belgium | Acceptable 2023-05-30
|
2023-05-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-11 | Belgium | Acceptable 2023-11-14
|
2023-11-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-05 | Belgium | Acceptable 2024-04-12
|
2024-04-15 |