NCT04866160 is a Phase 1 clinical trial of BI 1291583 in Healthy, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT04866160?

NCT04866160 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT04866160?

Interventions in NCT04866160: BI 1291583, Placebo.

Is NCT04866160 still recruiting?

NCT04866160 is currently completed. Last updated 13 August 2025.

Last reviewed 2025-08-13 · How we verify

NCT04866160

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Trial in Healthy Men and Women to Find Out How Well Different Doses of BI 1291583 Are Tolerated

Completed Phase 1 Last updated 13 August 2025

What this trial tests

Phase 1 trial testing BI 1291583 in Healthy in 24 participants. Completed in 30 November 2021.

Timeline

17 May 2021

Primary endpoint
30 November 2021

30 November 2021

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	24
Start date	17 May 2021
Primary completion	30 November 2021
Estimated completion	30 November 2021
Sites	1 location across Germany

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 18 to 50, any sex, 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 and female subjects following administration of multiple rising doses over 4 weeks and to explore the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1291583 after multiple dosing and assess the PK/PD relationship.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Novel cathepsin C inhibitor, BI 1291583, intended for treatment of bronchiectasis: Phase I characterization in healthy volunteers.
Badorrek P, Diefenbach C, Kögler H, Eleftheraki A, et al · · 2024 · cited 8× · PMID 39175217 · DOI 10.1111/cts.13891
The preclinical and phase 1 development of the novel oral cathepsin C inhibitor BI 1291583.
Chalmers JD, Badorrek P, Diefenbach C, Kögler H, et al · · 2024 · cited 8× · PMID 38529344 · DOI 10.1183/23120541.00725-2023
Dipeptidyl peptidase-1 inhibitors in bronchiectasis.
Johnson E, Gilmour A, Chalmers JD. · · 2025 · cited 5× · PMID 40533102 · DOI 10.1183/16000617.0257-2024

Verify or expand the search:

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.

NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04866160 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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/NCT04866160.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing