NCT07774325

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
2mo left

Started Sep 2026

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2026

20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2026

Last Updated

August 19, 2026

Status Verified

August 1, 2026

Enrollment Period

1 month

First QC Date

August 17, 2026

Last Update Submit

August 17, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

    up to 4 days

  • Maximum measured concentration of the analyte in plasma (Cmax)

    up to 4 days

Secondary Outcomes (1)

  • Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

    up to 4 days

Study Arms (2)

Treatment sequence 1

EXPERIMENTAL

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

Drug: BI 3000202Drug: CiclosporinDrug: Itraconazole

Treatment sequence 2

EXPERIMENTAL

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

Drug: BI 3000202Drug: CiclosporinDrug: Itraconazole

Interventions

BI 3000202DRUG

BI 3000202

Treatment sequence 1Treatment sequence 2
CiclosporinDRUG

Ciclosporin

Treatment sequence 1Treatment sequence 2
ItraconazoleDRUG

Itraconazole

Treatment sequence 1Treatment sequence 2

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male trial participant according to the assessment of the investigator, as based on a complete medical history, physical examination, vital signs (Blood pressure, Pulse rate), 12-lead Electrocardiogram, and clinical laboratory tests
  • Age of 18 to 55 years (inclusive)
  • Body mass index of 18.5 to 29.9 kg/m² (inclusive). Additionally, a minimum body weight of at least 60 kg is required
  • Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice and local legislation prior to admission to the trial

You may not qualify if:

  • Any finding in the medical examination (including Blood pressure, Pulse rate or Electrocardiogram) deviating from normal and assessed as clinically relevant by the investigator
  • Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • Any evidence of a concomitant disease assessed as clinically relevant by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

MeSH Terms

Interventions

CyclosporineItraconazole

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Central Study Contacts

Boehringer Ingelheim

CONTACT

18002430127clintriage.rdg@boehringer-ingelheim.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2026

First Posted

August 19, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

October 6, 2026

Study Completion (Estimated)

October 26, 2026

Last Updated

August 19, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Locations

DE(1)