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

Healthy Clinical Trial

Official title:

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Oral Doses of BI 1291583 qd Versus Placebo in Healthy Male and Female Subjects for 4 Weeks (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04866160
• Other study ID #: 1397-0011
• Secondary ID: 2020-006070-74
• Status: Completed
• Phase: Phase 1
• Start date: May 17, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: December 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 administration of multiple rising doses over 4 weeks and to explore the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1291583 after multiple dosing and assess the PK/PD relationship.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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 50 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 follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

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 50 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 Further exclusion criteria apply

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BI 1291583
BI 1291583
• Placebo
Placebo

Locations

Country	Name	City	State
Germany	Fraunhofer ITEM	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number (N) of subjects with drug-related AEs		up to 77 days
Secondary	Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose (AUCt,1)		up to 24 hours
Secondary	Maximum measured concentration of the analyte in plasma after administration of the first dose (Cmax,1)		up to 24 hours
Secondary	Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t (AUCt,ss)		at day 28
Secondary	Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t (Cmax,ss)		at day 28

External Links

•   Related Info