NCT05965583

Brief Summary

The main objective of this trial is to investigate the effect on the exposure of BI 1815368 in plasma when given as oral single dose together with multiple oral doses of itraconazole (Test, T) as compared to when given alone as oral single dose (Reference, R).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

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

July 19, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

August 2, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2023

Completed
Last Updated

November 3, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

July 19, 2023

Last Update Submit

November 2, 2023

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 day 7 after BI 1815368 administration

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

    Up to day 7 after BI 1815368 administration

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 day 7 after BI 1815368 administration

Study Arms (1)

BI 1815368 (Reference, R) then BI 1815368 + Itraconazole (Test, T)

EXPERIMENTAL
Drug: BI 1815368Drug: Itraconazole

Interventions

BI 1815368DRUG

BI 1815368

BI 1815368 (Reference, R) then BI 1815368 + Itraconazole (Test, T)
ItraconazoleDRUG

Itraconazole

Also known as: Sempera®
BI 1815368 (Reference, R) then BI 1815368 + Itraconazole (Test, T)

Eligibility Criteria

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

You may qualify if:

  • Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a 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 (BMI) of 18.5 to 29.9 kilograms per square meter (kg/m\^2) (inclusive)
  • Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) 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 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (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
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
  • Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
  • History of relevant orthostatic hypotension, fainting spells, or blackouts
  • Relevant chronic or acute infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Patients cross over from test treatment (T) to reference treatment (R) (two periods, fixed sequence).
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2023

First Posted

July 28, 2023

Study Start

August 2, 2023

Primary Completion

October 24, 2023

Study Completion

October 24, 2023

Last Updated

November 3, 2023

Record last verified: 2023-11

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.mystudywindow.com/msw/datatransparency

Locations

DE(1)