A Study in Healthy Men to Find Out How Blocking Certain Transport Proteins Affects the Amount of BI 3000202 in the Blood

Sponsor
Boehringer Ingelheim
Study ID
NCT07774325
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • BI 3000202 — DRUG
    BI 3000202
  • Ciclosporin — DRUG
    Ciclosporin
  • Itraconazole — DRUG
    Itraconazole

Study Details

The main objective of this trial is to investigate the effects of multiple doses of Itraconazole and multiple doses of Ciclosporin on the pharmacokinetics of BI 3000202 in plasma following a single oral dose in healthy male trial participants.

Key Dates

First listed
Aug 19, 2026
Start date
Sep 1, 2026
Status verified
Sep 2026
Primary completion
Oct 6, 2026
Completion
Oct 26, 2026

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment sequence 1
    Sequence: 1. \- Reference treatment (BI 3000202) 2. \- Test treatment 1 (BI 3000202 + Ciclosporin) 3. \- Test treatment 2 (BI 3000202 + Itraconazole)
  • Experimental: Treatment sequence 2
    Sequence: 1. \- Test treatment 1 (BI 3000202 + Ciclosporin) 2. \- Reference treatment (BI 3000202) 3. \- Test treatment 2 (BI 3000202 + Itraconazole)

Primary Outcome Measure

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) [ Time Frame: up to 4 days ]

Central Contacts

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