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NCT05183347
A Study in Healthy Japanese Men to Test How Well Different Doses of BI 1291583 Are Tolerated
Phase 1 trial testing BI 1291583 in Healthy in 36 participants. Completed in 27 July 2022.
27 July 2022
Quick facts
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 4 February 2022 |
| Primary completion | 27 July 2022 |
| Estimated completion | 27 July 2022 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- BI 1291583 — full drug profile →
- Placebo
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Boehringer Ingelheim — full company profile →
Who can join
Adults 20 to 45, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1291583 in healthy male Japanese subjects following oral administration of single rising doses and multiple doses.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05183347
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of BI 1291583
Trials testing the same drug.
- NCT07023354 — A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems · Phase 1 · recruiting
- NCT06872892 — The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis · Phase 3 · recruiting
- NCT06917872 — A Study in Healthy People to Test Whether Erythromycin Influences the Amount of BI 1291583 in the Blood · Phase 1 · completed
- NCT06791187 — A Study in Healthy People to Test Whether BI 1291583 Influences the Amount of Dabigatran in the Body · Phase 1 · completed
- NCT06631417 — A Study in Healthy People to Test How 2 Different Doses of BI 1291583 Are Taken up in the Body When Given in 3 Different · Phase 1 · completed
Other recruiting trials for Healthy
Currently open trials in the same condition.
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Other Boehringer Ingelheim trials
Trials by the same sponsor.
- NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
- NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
- NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
- NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
- NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05183347 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
- Last refreshed: 13 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05183347.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing