A Study to Test How Healthy Men Tolerate Different Doses of BI 1595043

Boehringer Ingelheim (Industry)
Overall Status
CT.gov ID
Anticipated Duration (Months)
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objectives of this trial are to investigate safety and tolerability of BI 1595043 in healthy male subjects following administration of multiple rising doses over 14 days.

Secondary objectives are the exploration of pharmacokinetics (PK) of BI 1595043 after single and multiple dosing.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Anticipated Enrollment :
50 participants
Intervention Model:
Parallel Assignment
Triple (Participant, Care Provider, Investigator)
Masking Description:
As this is a Multiple Rising Dose (MRD) trial, blinded individuals will be aware of the current dose level. All individuals are unblinded regarding the midazolam administration.
Primary Purpose:
Official Title:
Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1595043 (Double-blind, Randomised, Placebocontrolled, Parallel Group Design) in Healthy Male Subjects
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Dec 19, 2021
Anticipated Study Completion Date :
Dec 19, 2021

Arms and Interventions

Experimental: BI 1595043

Drug: BI 1595043
BI 1595043

Drug: Midazolam

Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

  1. Percentage (%) of subjects with drug-related adverse events [up to day 30]

Secondary Outcome Measures

  1. Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUC0-τ,ss) [up to day 24]

  2. Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss) [up to day 24]

  3. Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss) [up to day 24]

  4. Accumulation ratio based on area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUC0-τ,ss) (RA, AUC) [up to day 24]

  5. Accumulation ratio based on maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss) (RA, Cmax) [up to day 24]

Eligibility Criteria


Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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), body temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests

  • Age of 18 to 50 years (inclusive)

  • BMI of 18.5 to 29.9 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

  • Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:

  • Use of adequate contraception, i.e. use of condom (male subjects) plus any of the following methods (female partners): intrauterine device, hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration to the male subject, or barrier method (e.g. diaphragm with spermicide), or surgically sterilised (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy), or postmenopausal, defined as at least 1 year of spontaneous amenorrhea

  • Sexually abstinent

  • Vasectomised (vasectomy at least 1 year prior to enrolment) in combination with a barrier method (i.e. condom) Unprotected sexual intercourse (i.e. without use of condom) with a pregnant female partner and sperm donation is not allowed throughout the study and until 30 days after trial completion

Exclusion Criteria:
  • Any finding in the medical examination (including BP, PR or 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 millimetre 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

  • Further exclusion criteria apply

Contacts and Locations


SiteCityStateCountryPostal Code
1SGS Life Science Services - Clinical ResearchEdegemBelgium2650

Sponsors and Collaborators

  • Boehringer Ingelheim


None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:


None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • 1445-0002
  • 2020-004923-18
First Posted:
Mar 9, 2021
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021