Clinical trial NCT04866160: A Trial in Healthy Men and Women to Find Out How Well Different Doses of BI 1291583 Are Tolerated
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-04-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number (N) of subjects with drug-related AEs
timeFrame: up to 77 days
Secondary outcomes:
measure: 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)
timeFrame: up to 24 hours
measure: Maximum measured concentration of the analyte in plasma after administration of the first dose (Cmax,1)
timeFrame: up to 24 hours
measure: Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
timeFrame: at day 28
measure: Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
timeFrame: at day 28
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Fraunhofer ITEM
Study officials:
References: