Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
40
Countries
1
Sites
1
Acute ischemic stroke
Investigate the safety and tolerability of BAY 3018250 after single doses of 150 mg up to 1200 mg, administered as intravenous infusion in healthy male participants.
Key facts
- Sponsor
- Bayer AG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 8 Nov 2022 → 12 May 2023
- Decision date (initial)
- 2022-10-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Bayer AG, Leverkusen, Germany
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Pharmacodynamic, Pharmacogenetic, Safety
Investigate the safety and tolerability of BAY 3018250 after single doses of 150 mg up to 1200 mg, administered as intravenous infusion in healthy male participants.
Secondary objectives 1
- Investigate the pharmacokinetics (PK) of BAY 3018250
Conditions and MedDRA coding
Acute ischemic stroke
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10043565 | Thromboembolic event | 10047065 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Period 1 Treatment Period 1: Day -1 to Day 6 (maximum to Day 12), with single dose administration of the IMP on Day 1
|
Randomised Controlled | Single | [{"id":4704,"code":1,"name":"Subject"}] | BAY 3018250: Each subject receive a single dose of BAY3018250 Placebo: Each subject receive a single dose of placebo |
| 2 | Period 2 Follow up Period 2: Follow-up visits on Day 14, 28, and 42 (further follow-up on Day 63 and Day 84 if needed)
|
Randomised Controlled | Single | [{"id":4706,"code":1,"name":"Subject"}] | BAY 3018250: Each subject receive a single dose of BAY3018250 Placebo: Each subject receive a single dose of placebo |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Men must be 18 to 45 years of age inclusive at the time of signing the informed consent
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, safety laboratory tests, vital signand 12-lead electrocardiogram (ECG)
- Body weight equal or above 65 kg and body mass index above or equal 18.0 to below or equal to 29.9 kg/m2 (inclusive) at screening
- Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Exclusion criteria 10
- Medical disorder, condition or history of such that would impair the participant’s ability to take part in or complete this study in the opinion of the investigator. This includes family history indicating hereditary predisposition of relevant diseases and history of non- persisting diseases with possible impact on study participation
- Diseases for which it can be assumed that effects of the study intervention(s) will not be normal
- Known hypersensitivity to any study intervention (active substances or excipients of the preparations) to be used in the study – including e.g. non-investigational medicinal products, challenge agents, or rescue medication
- Known severe allergies, e.g. allergies affecting the lower respiratory tract – allergic asthma, allergies requiring therapy with corticosteroids, urticaria or significant non-allergic drug reactions
- Participants with tendency to the develop Keloid or major scars after injuries
- Known coagulation disorders (e.g., von Willebrand´s disease, hemophilia)
- Known disorders with increased bleeding risk (e.g., periodontitis, symptomatic hemorrhoids, acute gastritis, peptic ulcer etc.)
- Known sensitivity to common causes of bleeding (e.g., nasal, etc.)
- History of hemorrhage and gastro-intestinal ulceration within 6 month prior to the screening visit
- Clinically relevant findings in the physical examination
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Number of participants who experienced treatment-emergent adverse events(TEAEs) and drug-related TEAEs after administration of BAY3018250
Secondary endpoints 2
- Cmax and Cmax/D of BAY3018250
- AUC and AUC/D of BAY3018250 (if AUC cannot be determined reliably in all participants, AUC(0-t) will be used instead)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9764741 · Product
- Active substance
- BAY 3018250
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 1500 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- BAYER AG
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Placebo equals test product, except active substance
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bayer AG
- Sponsor organisation
- Bayer AG
- City
- Leverkusen
- Postcode
- 51368
- Country
- Germany
Scientific contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Third parties 5
| Organisation | City, country | Duties |
|---|---|---|
| ClinAssess Gesellschaft fuer Klinische Forschung mbH ORG-100009848
|
Leverkusen, Germany | On site monitoring |
| Mlm Medical Labs GmbH ORG-100043721
|
Mönchengladbach, Germany | Laboratory analysis |
| Nuvisan GmbH ORG-100011873
|
Neu-Ulm, Germany | Laboratory analysis |
| CRS Clinical Research Services Management GmbH ORG-100039537
|
Wuppertal, Germany | Code 11, Code 13, E-data capture |
| Nabios Gesellschaft fuer medizinische Datenanalysen mbH ORG-100043939
|
Munich, Germany | Laboratory analysis |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 40 | 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 |
|---|---|---|---|---|---|
| Germany | 2022-11-08 | 2022-11-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| CTIS Summary of Results_2022-500505-41-00 SUM-24056
|
2024-05-06T10:51:54 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| A first-in-human study to learn about how safe BAY 3018250 is in healthy men_2022-500505-41-00 | 2024-05-06T10:52:17 | Submitted | Laypersons Summary of Results |
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Layperson summary of results_EN_2022-500505-41-00_public | 1 |
| Summary of results (for publication) | Summary of Results_EN_2022-500505-41-00_public | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-07-18 | Germany | Acceptable 2022-08-30
|
2022-10-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2022-12-20 | Germany | Acceptable 2022-08-30
|
2022-12-20 |