Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ended
Participants planned
14
Countries
1
Sites
1
Healthy volunteer trial
The main objective of this trial is to investigate the effect of a strong CYP3A4 inhibitor on the pharmacokinetics of BI 1584862.
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
- 29 Sep 2023 → 10 Nov 2023
- Decision date (initial)
- 2023-09-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-503542-31-00
- WHO UTN
- U1111-1291-2853
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic
The main objective of this trial is to investigate the effect of a strong CYP3A4 inhibitor on the pharmacokinetics of BI 1584862.
Conditions and MedDRA coding
Healthy volunteer trial
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10053349 | Pharmacokinetic study | 10022891 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening period 21 days
|
Not Applicable | None | All participants: All participants | |
| 2 | Treatment period 2 days for reference treatment without itraconazole, 5 days for test treatment with itraconazole
|
2 | None | BI 1584862 alone (reference treatment) then BI 1584862 + itraconazole (test treatment): BI 1584862 alone (reference treatment) then BI 1584862 + itraconazole (test treatment) | |
| 3 | End of trial period 9 days
|
Not Applicable | None | All participants: All participants |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- Age of 18 to 50 years (inclusive)
- BMI of 18.5 to 29.9 kg/m2 (inclusive)
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Exclusion criteria 5
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- 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 pulse rate outside the range of 45 to 90 bpm
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- Further exclusion criteria apply.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
- Cmax (maximum measured concentration of the analyte in plasma)
Secondary endpoints 1
- AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10222486 · Product
- Active substance
- BI 1584862
- Pharmaceutical form
- FILM COATED TABLETS
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
Sempera Liquid 10 mg/ml Lösung zum Einnehmen
PRD710419 · Product
- Active substance
- Itraconazole
- Substance synonyms
- ORICONAZOLE
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- J02AC02 — ITRACONAZOLE
- Marketing authorisation
- 39682.00.00
- MA holder
- JANSSEN-CILAG GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
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 |
|---|---|---|---|
| Germany | Ended | 14 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Boehringer Ingelheim Pharma GmbH & Co. KG
Global Clinical Development & Operations, Birkendorfer Strasse 65, 88397, Biberach An Der Riss
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 | 2023-09-29 | 2023-11-10 | 2023-10-04 | 2023-10-13 |
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 |
|---|---|---|---|
| Summary of results 1484-0003 SUM-51784
|
2024-10-16T11:06:04 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay person summary of results 1484-0003 | 2024-10-16T11:06:12 | Submitted | Laypersons Summary of Results |
Documents 3 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Lay summary-english-1484-0003-public | 1 |
| Laypersons summary of results (for publication) | Lay summary-german-1484-0003-public | 1 |
| Summary of results (for publication) | CTR synopsis 1484-0003-public | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-13 | Germany | Acceptable 2023-09-08
|
2023-09-08 |