Overview
Sponsor-declared trial summary
Healthy
Part A – the primary objective is • To assess the mass balance and total recovery of [14C]-radioactivity in urine and faeces after oral single dose administration of BI 1810631 (C-14) (test treatment T1) in healthy male subjects Part B – the primary objective is: • To investigate the absolute bioavailability of BI 1…
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
- 10 Aug 2023 → 19 Oct 2023
- Decision date (initial)
- 2023-07-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Others, Safety
Part A – the primary objective is
• To assess the mass balance and total recovery of [14C]-radioactivity in urine and faeces after oral single dose administration of BI 1810631 (C-14) (test treatment T1) in healthy male subjects
Part B – the primary objective is:
• To investigate the absolute bioavailability of BI 1810631 administered as film-coated tablet (test treatment T2, not radio-labelled) compared with BI 1810631 (C-14) (reference treatment R) administered as intravenous microtracer"
Secondary objectives 1
- Part A – the secondary objective is • To assess concentrations of BI 1810631 and [14C]-radioactivity in plasma
Conditions and MedDRA coding
Healthy
| 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 from Day -28 to Day -2 prior to trial start
|
Not Applicable | None | Part A: All participants Part B: All participants |
|
| 2 | Treatment period "Up to 43 days for Part A
Up to 8 days for Part B"
|
Not Applicable | None | Part A: BI 1810631 (C-14) Part B: BI 1810631 then BI 1810631 (C-14) |
|
| 3 | End of Trial "from Day 16 to Day 34 for Part A
from Day 15 to Day 22 for Part B"
|
Not Applicable | None | Part A: All participants Part B: 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 55 years (inclusive)
- BMI of 18.0 to 30.0 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 145 mmHg, diastolic blood pressure outside the range of 45 to 90 mmHg, or pulse rate outside the range of 40 to 100 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
- Part A – Primary endpoints will be the mass balance and total recovery of [14C]-radioactivity in urine and faeces: • feurine, 0-tz (fraction excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point) • fefaeces, 0-tz (fraction excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point)
- Part B – The following primary endpoint will be determined in plasma for [14C]BI 1810631 after intravenous administration and for BI 1810631 after oral administration: • AUC0-∞ (area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity)
Secondary endpoints 2
- Part A – for BI 1810631 and for [14C]-radioactivity (assessed by [14C]BI 1810631-EQ) in plasma: • Cmax (maximum measured concentration of the analyte) • AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point)
- Part B – for [14C]BI 1810631 after intravenous administration and for BI 1810631 after oral administration: • Cmax • AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD10422157 · Product
- Active substance
- BI 1810631 (C-14)
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 100 µg microgram(s)
- Max total dose
- 100 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
PRD10363333 · Product
- Active substance
- BI 1810631
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
PRD10422069 · Product
- Active substance
- BI 1810631 (C-14)
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- 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
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Pharmaceutical Research Associates Group B.V. ORG-100006268
|
Groningen, Netherlands | Code 11, Other, Code 5 |
| Pharmaceutical Research Associates Group B.V. ORG-100006268
|
Assen, Netherlands | Laboratory analysis |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 15 | 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 |
|---|---|---|---|---|---|
| Netherlands | 2023-08-10 | 2023-10-19 | 2023-08-14 | 2023-09-14 |
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 |
|---|---|---|---|
| CTR Synopsis SUM-52073
|
2024-10-18T16:31:53 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| CTR Lay summary | 2024-10-18T16:31:30 | 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) | 1479-0006-lay-summary-dutch | 1 |
| Laypersons summary of results (for publication) | 1479-0006-lay-summary-english | 1 |
| Summary of results (for publication) | 1479-0006-ctr-synopsis-ema-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 | Netherlands | Acceptable 2023-07-17
|
2023-07-17 |