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NCT05520827
A Study in Healthy Men to Test How Different Doses of BI 1584862 Are Tolerated and How BI 1584862 is Taken up in the Body With or Without Food
Phase 1 trial testing BI 1584862 in Healthy in 77 participants. Completed in 6 March 2023.
6 March 2023
Quick facts
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 77 |
| Start date | 29 September 2022 |
| Primary completion | 6 March 2023 |
| Estimated completion | 6 March 2023 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- BI 1584862 — full drug profile →
- Placebo
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Boehringer Ingelheim — full company profile →
Who can join
Adults 18 to 45, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Single Rising Dose (SRD) part: The main objectives of the SRD part of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 1584862 in healthy male subjects following oral administration of single rising doses. Food Effect (FE) part: The main objective of the FE part is to assess the influence of food on the relative bioavailability of the BI 1584862 tablet.
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 NCT05520827
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of BI 1584862
Trials testing the same drug.
- NCT06957756 — A Study to Test How BI 1584862 is Taken up in the Blood of People With and Without Liver Problems · Phase 1 · recruiting
- NCT06769048 — A Study to Test Different Doses of BI 1584862 in People With a Distinct Form of Age-related Macular Degeneration (AMD) C · Phase 2 · active not recruiting
- NCT06148948 — A Study in Healthy Men to Test How Well Different Doses of BI 1584862 Are Tolerated · Phase 1 · completed
- NCT06041438 — A Study in Healthy Men to Test Whether Itraconazole Influences the Amount of BI 1584862 in the Blood · Phase 1 · completed
- NCT06006598 — A Study to Test How Well Different Doses of BI 1584862 Are Tolerated by Healthy Men · Phase 1 · completed
Other recruiting trials for Healthy
Currently open trials in the same condition.
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- NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
- NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting
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 NCT05520827 (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: 9 March 2023
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/NCT05520827.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing