A Study in Healthy Men and Women to Find Out How Well Different Doses of BI 1291583 Are Tolerated

NCT03868540 | Terminated Phase 1

• 2 other identifiers: 1397-00022018-001245-14
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1291583 in healthy male and female subjects following oral administration of multiple rising doses over 4 weeks.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with drug-related adverse events

  Percentage of participants with drug-related adverse events.

  From first intake of trial medication until 21 days (Residual Effect Period) after the last drug administration, up to 49 days.

Secondary Outcomes (4)

• Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose (AUCτ,1)

  Within 3 hours (h) before the first drug administration and 1, 2, 4, 6, 8, 10, 12, 14, 24 hours afterwards.

• Maximum measured concentration of the analyte in plasma after administration of the first dose (Cmax,1)

  Within 3 hours (h) before the first drug administration and 1, 2, 4, 6, 8, 10, 12, 14, 24 hours afterwards.

• Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)

  Within 15 minutes prior to last drug administration (timepoint of last drug administration: 648 hours after first drug administration) and 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours after the last drug administration.

• Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)

  Within 15 minutes prior to last drug administration (timepoint of last drug administration: 648 hours after first drug administration) and 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours after last drug administration.

Study Arms (2)

BI 1291583

EXPERIMENTAL

Drug: BI 1291583

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 1291583 DRUG

tablet

Also known as: Verducatib

BI 1291583

Placebo DRUG

tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy 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 45 years (inclusive)
• Body mass index (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, or female (of non-childbearing potential) subjects -- For 'female of non-childbearing potential' at least one of the following criteria must be fulfilled:
• Permanently sterile (permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy)
• Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)

You may not qualify if:

• 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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 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
• 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
• 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 of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)
• Intake of an investigational drug in another clinical trial within 60 days of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
• Inability to refrain from smoking during in-house confinement
• Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

CRS Clinical Research Services Mannheim GmbH

Mannheim, 68167, Germany

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 11, 2019
• Study Start: March 28, 2019
• Primary Completion: November 25, 2019
• Study Completion: November 25, 2019
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)