Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
16
Countries
1
Sites
1
Healthy
The main objective of this trial is to investigate the basic pharmacokinetics of BI 764198 and its metabolites, total radioactivity including mass balance, excretion pathways and metabolism using a classical hADME approach and a microtracer approach.
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 3 May 2023 → 9 Nov 2023
- Decision date (initial)
- 2023-04-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-502327-22-00
- WHO UTN
- U1111-1289-0105
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Safety, Pharmacokinetic
The main objective of this trial is to investigate the basic pharmacokinetics of BI 764198 and its metabolites, total radioactivity including mass balance, excretion pathways and metabolism using a classical hADME approach and a microtracer approach.
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 Screen for entry into treatment period: 20 days (from Day -21 to
Day -2)
|
Not Applicable | None | All Participants: All Participants | |
| 2 | Treatment 31 days (from Day 1 to Day 31)
|
Not Applicable | None | Treatment 1: BI 764198 (C-14) (hADME) (N=8): Treatment 1: BI 764198 (C-14) (hADME) (N=8) Treatment 2: BI 764198 (C-14) (microtracer) (N=8): Treatment 2: BI 764198 (C-14) (microtracer) (N=8) |
|
| 3 | End of study (EoS) 21 days (from Day 11 to Day 31)
|
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 65 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 6
- 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 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.
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
- Further criteria apply, see protocol.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Mass balance recoveries of total radioactivity in urine and faeces: feurine,0-tz (fraction of [14C]-radioactivity excreted in urine expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point).
- Mass balance recoveries of total radioactivity in urine and faeces: fefaeces,0-tz (fraction of [14C]-radioactivity excreted in faeces expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point).
Secondary endpoints 2
- The following endpoints will be determined for [14C]- radioactivity and for BI 764198: Cmax (maximum measured concentration of the analyte) in plasma.
- AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable data point) in plasma.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10226793 · Product
- Active substance
- Bi 764198 Xx (C-14)
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
[4-6-AMINOPYRIDAZIN-3-YLPIPERIDIN-1-YL5-4-FLUOROPHENOXY-4-METHOXYPYRIDIN-2-YLMETHANONE
PRD10218910 · Product
- Active substance
- [4-6-AMINOPYRIDAZIN-3-YLPIPERIDIN-1-YL5-4-FLUOROPHENOXY-4-METHOXYPYRIDIN-2-YLMETHANONE
- Substance synonyms
- BI 764198
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 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
|
Assen, Netherlands | Laboratory analysis |
| Pharmaceutical Research Associates Group B.V. ORG-100006268
|
Groningen, Netherlands | Code 11, Other, Code 5 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 16 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 | 2023-05-03 | 2023-11-09 | 2023-05-09 | 2023-06-20 |
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 1434-0016 SUM-53087
|
2024-10-22T14:35:32 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| CTR Lay Summary | 2024-10-22T14:35:45 | 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) | 1434-0016-Lay-Summary-english | 1 |
| Summary of results (for publication) | 1434-0016-CTR-Disclosure Synopsis_public | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-27 | Netherlands | Acceptable 2023-04-12
|
2023-04-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-06-02 | Netherlands | Acceptable 2023-06-28
|
2023-06-28 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-08-24 | Netherlands | Acceptable 2023-08-30
|
2023-08-30 |