Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
68
Countries
1
Sites
1
Healthy volunteer trial
The main objectives of the SRD part of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3000202 in healthy male subjects following administration of single rising doses. The main objective of the FE part is to investigate the relative bioavailability of BI 3000202 and to assess the inf…
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
- 25 Jul 2023 → 13 Nov 2023
- Decision date (initial)
- 2023-06-14
- 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: Safety, Others, Pharmacokinetic
The main objectives of the SRD part of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3000202 in healthy male subjects following administration of single rising doses.
The main objective of the FE part is to investigate the relative bioavailability of BI 3000202 and to assess the influence of food on the relative bioavailability of BI 3000202.
Conditions and MedDRA coding
Healthy volunteer trial
Study design 7 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | SRD part - Screening Day -21 to day -1
|
Not Applicable | None | All participants: All participants | |
| 2 | SRD part: Dose escalation Day 1 to day 3
|
Randomised Controlled | Single | [{"id":14224,"code":1,"name":"Subject"}] | Dose Group 1, Treatment: n=6 Dose group 1, Placebo: n=2 Dose Group 2, Treatment: n=6 Dose group 2, Placebo: n=2 Dose Group 3, Treatment: n=6 Dose group 3, Placebo: n=2 Dose Group 4, Treatment: n=6 Dose group 4, Placebo: n=2 Dose Group 5, Treatment: n=6 Dose group 5, Placebo: n=2 Dose Group 6, Treatment: n=6 Dose group 6, Placebo: n=2 Dose Group 7, Treatment: n=6 Dose group 7, Placebo: n=2 |
| 3 | SRD part: End of study examination Day 4 to day 14
|
Not Applicable | None | All participants: All participants | |
| 4 | FE part - Screening Day -21 to day -1
|
Not Applicable | None | All participants: All participants | |
| 5 | FE part: Treatment period 1 Day 1 to day 3 (of period 1)
|
Randomised Controlled | None | Treatment sequence R - T: treatment under fasted (R) condition, then treatment under fed (T) condition, n=12 | |
| 6 | FE part: Treatment period 2 Day 1 to day 3 (of period 2)
|
Randomised Controlled | None | Treatment sequence T - R: treatment under fed (T) condition, then treatment under fasted (R) condition, n=12 | |
| 7 | FE part: End of study examination Day 4 to day 14
|
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 without any clinically significant abnormalities
- Age of 18 to 45 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 50 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 3
- SRD part: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator. This is expressed as the percentage of subjects treated with investigational drug who experience such an event.
- FE part: AUC0-24 (area under the concentration-time curve of the analyte in plasma over the dosing interval 0 to 24 hours)
- FE part: Cmax (maximum measured concentration of the analyte in plasma)
Secondary endpoints 3
- SRD part: AUC0-24 (area under the concentration-time curve of the analyte in plasma over the dosing interval 0 to 24 hours)
- SRD part: Cmax (maximum measured concentration of the analyte in plasma)
- FE part: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD10301143 · Product
- Active substance
- BI 3000202
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 3 mg milligram(s)
- Max total dose
- 3 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
PRD10301146 · Product
- Active substance
- BI 3000202
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
PRD10301156 · Product
- Active substance
- BI 3000202
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
PRD10301158 · Product
- Active substance
- BI 3000202
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 250 mg milligram(s)
- Max total dose
- 250 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
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
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 | 68 | 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 | 2023-07-25 | 2023-11-13 | 2023-07-27 | 2023-10-20 |
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 1509-0001 SUM-54802
|
2024-10-30T14:15:33 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay summary 1509-0001 | 2024-10-30T14:15:42 | 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-1509-0001 | 1 |
| Laypersons summary of results (for publication) | Lay summary-german-1509-0001 | 1 |
| Summary of results (for publication) | CTR synopsis 1509-0001-public | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-13 | Germany | Acceptable 2023-06-07
|
2023-06-14 |