NCT03754959

Brief Summary

The primary objective of the trial is to investigate the safety and tolerability of BI 1358894 in healthy male subjects following oral administration of multiple rising doses over 14 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Dec 2018

Typical duration for phase_1 healthy

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

November 26, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

December 18, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2019

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

April 3, 2025

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

November 26, 2018

Results QC Date

February 6, 2025

Last Update Submit

March 14, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With On-treatment Drug-related Adverse Events (AEs).

    Number of subjects with on-treatment drug-related Adverse Events (AEs).

    Midazolam: Up to 1 day, BI 1358894 or Placebo + Midazolam: Up to 1 day and BI 1358894: Up to 13 days.

Secondary Outcomes (8)

  • Area Under the Concentration-time Curve of BI 1358894 in Plasma Over a Time Interval 0 to 24 h After Administration of the First Dose

    Within 2 hours before and 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 27, 48, 72, 75, 96, 120, 123, 144, 192, 195, 240, 243, 288, 311, 312.17, 312.33, 312.5, 313, 314, 315, 316, 318, 320, 324, 336, 360, 384, 408, 432, 456, 504 hours after administration.

  • Maximum Measured Concentration of BI 1358894 in Plasma

    Within 2 hours before and 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 27, 48, 72, 75, 96, 120, 123, 144, 192, 195, 240, 243, 288, 311, 312.17, 312.33, 312.5, 313, 314, 315, 316, 318, 320, 324, 336, 360, 384, 408, 432, 456, 504 hours after administration.

  • Area Under the Concentration-time Curve of BI 1358894 in Plasma at Steady State Over a Uniform Dosing Interval Ï„

    Within 2 hours before and 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 27, 48, 72, 75, 96, 120, 123, 144, 192, 195, 240, 243, 288, 311, 312.17, 312.33, 312.5, 313, 314, 315, 316, 318, 320, 324, 336, 360, 384, 408, 432, 456, 504 hours after administration.

  • Maximum Measured Concentration of BI 1358894 in Plasma at Steady State Over a Uniform Dosing Interval Ï„

    Within 2 hours before and 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 27, 48, 72, 75, 96, 120, 123, 144, 192, 195, 240, 243, 288, 311, 312.17, 312.33, 312.5, 313, 314, 315, 316, 318, 320, 324, 336, 360, 384, 408, 432, 456, 504 hours after administration.

  • Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (Day 1)

    25.5, 23.83, 23.5, 23, 22, 21.5, 21, 20, 18, 16 and 1 hour before and 0.17, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 311, 312.33, 312.5, 313, 314, 314.5, 315, 316, 318 and 320 hours after administration of BI 1358894 .

  • +3 more secondary outcomes

Study Arms (5)

Dose Group 1

EXPERIMENTAL
Drug: BI 1358894Drug: PlaceboDrug: Midazolam

Dose Group 2

EXPERIMENTAL
Drug: BI 1358894Drug: PlaceboDrug: Midazolam

Dose Group 3

EXPERIMENTAL
Drug: BI 1358894Drug: PlaceboDrug: Midazolam

Dose Group 4

EXPERIMENTAL
Drug: BI 1358894Drug: PlaceboDrug: Midazolam

Dose Group 5

EXPERIMENTAL
Drug: BI 1358894Drug: PlaceboDrug: Midazolam

Interventions

BI 1358894DRUG

Film-coated tablet

Dose Group 1Dose Group 2Dose Group 3Dose Group 4Dose Group 5
PlaceboDRUG

Film-coated tablet

Dose Group 1Dose Group 2Dose Group 3Dose Group 4Dose Group 5
MidazolamDRUG

Solution for injection

Dose Group 1Dose Group 2Dose Group 3Dose Group 4Dose Group 5

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects according to the investigator's assessment, 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 45 years (incl.)
  • Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
  • Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
  • Willingness to comply with contraception requirements. Subjects who are sexually active must use adequate contraception with their female partner throughout the study and until one month after the last administration of trial medication. Adequate methods are:
  • Sexual abstinence or
  • A vasectomy performed at least 1 year prior to screening (with medical assessment of the surgical success) or
  • Surgical sterilisation (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner or
  • The use of condoms, if the female partner uses an adequate contraception method in addition, e.g., intrauterine device (IUD), hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration, or barrier method (e.g. diaphragm with spermicide) Unprotected sexual intercourse with a female partner is not allowed throughout the study and until one month after the last administration of trial medication.

You may not qualify if:

  • Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged 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 50 to 90 beats per minute (bpm)
  • C-Reactive Protein \> upper limit of normal (ULN), erythrocyte sedimentation rate (ESR) ≥15 millimeters/h, liver or kidney parameter above ULN, or any other laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • Positive or missing faecal occult blood test (retest allowed)
  • Positive testing for faecal calprotectin (retest allowed)
  • Any evidence of a concomitant disease judged as clinically relevant by the investigator
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and 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
  • Chronic or relevant acute infections
  • History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
  • Use of drugs within 30 days prior to administration of trial medication that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
  • Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug
  • Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRS Clinical Research Services Mannheim GmbH

Mannheim, 68167, Germany

Location

Related Publications (1)

  • Fuertig R, Goettel M, Herich L, Hoefler J, Wiebe ST, Sharma V. Effects of Single and Multiple Ascending Doses of BI 1358894 in Healthy Male Volunteers on Safety, Tolerability and Pharmacokinetics: Two Phase I Partially Randomised Studies. CNS Drugs. 2023 Dec;37(12):1081-1097. doi: 10.1007/s40263-023-01041-4. Epub 2023 Nov 29.

    PMID: 38019355DERIVED

MeSH Terms

Interventions

TRPC inhibitor BI 1358894Midazolam

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Boehringer Ingelheim, Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2018

First Posted

November 27, 2018

Study Start

December 18, 2018

Primary Completion

July 22, 2019

Study Completion

July 22, 2019

Last Updated

April 3, 2025

Results First Posted

April 3, 2025

Record last verified: 2025-03

Locations

DE(1)