Clinical trial NCT05738291: A Study in Healthy Men to Test How Well Multiple Doses of BI 1839100 Are Tolerated and How BI 1839100 Influences the Amount of Other Medicines in the Blood
Official title: A Phase I Study to Assess Safety, Tolerability, Pharmacokinetics and Effect of Food on Multiple Rising Oral Doses of BI 1839100 (Single-blind, Randomised, Placebo-controlled, Parallel Group Design) and the Effect of Multiple Doses of BI 1839100 on the Single Dose Pharmacokinetics of Cytochrome P450 Substrate (Midazolam), a P Glycoprotein Substrate (Digoxin) and OATP Substrate (Rosuvastatin) Administered Orally (Open-label, Fixed-sequence) in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-02-22
Enrollment: 67
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The multiple-rising dose (MRD) part of this trial is designed as single blinded to subject, randomised, and placebo-controlled within parallel dose groups.

The Drug-Drug Interaction (DDI) part of this trial is designed as open-label, within-group comparison interaction trial.
Primary purpose: TREATMENT

Brief summary: Effects of multiple rising doses of BI 1839100 on safety, tolerability, pharmacokinetics and the effect of high-fat meal on pharmacokinetics of BI 1839100 will be assessed as well as assessing potential drug-drug interactions.


Eligibility criteria: Inclusion Criteria:

* Physically and mentally 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)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 31.9 kg/m2 (inclusive)
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

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(s) 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) (subjects with heart rate values between 45 and 50 bpm may only be enrolled in case they have a normal thyroid function, no clinical symptoms associated with the bradycardia and no apparent signs of other diseases causing bradycardia such as hypothyroidism or heart conduction abnormalities)
* 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 assessed as clinically relevant by the investigator
* 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 assessed as clinically relevant by the investigator
* History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Primary outcomes:
measure: MRD part: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
timeFrame: up to 26 days
measure: DDI part: Area under the concentration-time curve of midazolam, digoxin and rosuvastatin when administered without BI 1839100 over the time interval from 0 to the last quantifiable data point (AUC0-tz)
timeFrame: up to 20 days
measure: DDI part: Maximum measured concentration of midazolam, digoxin and rosuvastatin when administered without BI 1839100 in plasma (Cmax)
timeFrame: up to 20 days
measure: DDI part: Area under the concentration-time curve of midazolam, digoxin and rosuvastatin when co-administered with BI 1839100 over the time interval from 0 to the last quantifiable data point (AUC0-tz)
timeFrame: up to 7 days
measure: DDI part: Maximum measured concentration of midazolam, digoxin and rosuvastatin when co-administered with BI 1839100 in plasma (Cmax)
timeFrame: up to 7 days
Secondary outcomes:
measure: MRD part: Maximum measured concentration of the analyte in plasma after single dose (Cmax)
timeFrame: at Day 1
measure: MRD part: Time from dosing to maximum measured concentration of the analyte in plasma (tmax)
timeFrame: at Day 1
measure: MRD part: Area under the concentration-time curve of the analyte in plasma over the time interval 0 to 12 hours (AUC0-12)
timeFrame: at Day 1
measure: MRD part: Area under the concentration-time curve of the analyte in plasma over the time interval 0 to 48 hours (AUC0-48)
timeFrame: up to 48 hours
measure: MRD part: Area under the concentration-time curve of the analyte in plasma over a uniform 12 hours dosing interval (τ) [after Nth dose] (AUCτ( ,N))
timeFrame: up to 17 days
measure: MRD part: Maximum measured concentration of the analyte in plasma [after Nth dose] (Cmax( ,N))
timeFrame: up to 17 days
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: ICON-Groningen-62040
Study officials:
References: