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NCT03854552

A Study in Healthy Men Tests How Different Doses of BI 764198 Are Taken up in the Body and How Well They Are Tolerated.

Completed Phase 1 Last updated 8 November 2021
What this trial tests

Phase 1 trial testing BI 764198 in Healthy in 72 participants. Completed in 7 August 2019.

Timeline
15 March 2019
Primary endpoint
7 August 2019
7 August 2019

Quick facts

Lead sponsorBoehringer Ingelheim
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment72
Start date15 March 2019
Primary completion7 August 2019
Estimated completion7 August 2019
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

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

The main objective of this trial is to investigate safety and tolerability of BI 764198 in healthy male subjects following oral administration of single rising doses. Secondary objectives are the exploration of pharmacokinetics (PK) including dose proportionality of BI 764198 after single oral dosing.

Publications & conference data

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

  1. TRPC6 Inhibitor BI 764198 in Focal Segmental Glomerulosclerosis: Phase 2 Study Design.
    Trachtman H, Kretzler M, Desmond HE, Choi W, et al · · 2023 · cited 21× · PMID 38106603 · DOI 10.1016/j.ekir.2023.09.026
  2. Pharmacological TRPC6 inhibition improves survival and muscle function in mice with Duchenne muscular dystrophy.
    Lin BL, Shin JY, Jeffreys WP, Wang N, et al · · 2022 · cited 20× · PMID 36099033 · DOI 10.1172/jci.insight.158906
  3. Transient Receptor Potential Canonical 6 (TRPC6) Channel in the Pathogenesis of Diseases: A Jack of Many Trades.
    Saqib U, Munjuluri S, Sarkar S, Biswas S, et al · · 2023 · cited 18× · PMID 37072606 · DOI 10.1007/s10753-023-01808-3
  4. Phase 1 trials of BI 764198, a transient receptor potential channel 6 inhibitor, in healthy volunteers and participants with kidney impairment.
    Schultz A, Halabi A, Seitz F, Lemmens K, et al · · 2025 · cited 3× · PMID 40455255 · DOI 10.1080/13543784.2025.2510673
  5. Physiological functions and pharmacological targeting of transient receptor potential channels.
    Chubanov V, Grimm C, Hill K, Schaefer M, et al · · 2025 · PMID 41118703 · DOI 10.1016/j.pharmr.2025.100089

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