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A Study in Healthy Men to Test How Fluconazole Influences the Amount of BI 425809 in the Blood

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT05076409
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
2.7
Actual Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objective of this trial is to investigate the effect of fluconazole, under steady state conditions on the pharmacokinetics of BI 425809 (Reference Treatment R: BI 425809 alone; Test Treatment T: BI 425809 given under steady state conditions of fluconazole).

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Fluconazole on the Pharmacokinetics of a Single Oral Dose of BI 425809 in Healthy Male Subjects (an Open-label, Two-period Fixed-sequence Design Study)
Actual Study Start Date :
Oct 19, 2021
Actual Primary Completion Date :
Jan 10, 2022
Actual Study Completion Date :
Jan 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: All participants

Drug: BI 425809
Period 1 and period 2

Drug: fluconazole
Period 2

Outcome Measures

Primary Outcome Measures

  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 215 hours post administration of BI 425809 (AUC0-215h) [up to 215 hours]

  2. Maximum measured concentration of the analyte in plasma (Cmax) [up to 215 hours]

Secondary Outcome Measures

  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) [up to 215 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 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 (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests

  • Age of 18 to 55 years (inclusive)

  • Body mass index (BMI) of 18.5 to 29.9 Kilograms/Square Meter (kg/m2) (inclusive)

  • Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

  • Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator

  • Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetres 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

  • Relevant 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 Further exclusion criteria apply.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Humanpharmakologisches Zentrum Biberach Biberach Germany 88397

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT05076409
Other Study ID Numbers:
  • 1346-0017
  • 2021-003389-10
First Posted:
Oct 13, 2021
Last Update Posted:
Jan 12, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fluconazole
BI 425809

Study Results

No Results Posted as of Jan 12, 2022