Phase 1
N=70
A Study in Healthy Men and Women Who Are Either Between 18 - 45 Years or Between 65 - 80 Years to Test How Different Doses of BI 474121 Are Tolerated
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04537897 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Percentage of Participants With Drug-related Adverse Events — 40.0; 75.0; 50.0; 75.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 474121 (Drug); Midazolam (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Drug-related Adverse Events |
40.0; 75.0; 50.0; 75.0; 87.5; 100.0 | — |
| SECONDARY Area Under the Concentration-time Curve of BI 474121 in Plasma From 0 to 24h (AUC0-24) After First Dose |
230; 486; 862; 1650; 2430; 410 | — |
| SECONDARY Maximum Measured Concentration of BI 474121 in Plasma (Cmax) After First Dose |
22.6; 43.9; 82.4; 167; 229; 44.3 | — |
| SECONDARY Area Under the Concentration-time Curve of BI 474121 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) |
471; 797; 1280; 2870; 4350; 764 | — |
| SECONDARY Maximum Measured Concentration of BI 474121 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) |
40.1; 67.8; 113; 249; 385; 60.6 | — |
| SECONDARY Maximum Measured Concentration of Midazolam in Plasma (Cmax) - Day -1 |
980; 747; 1460; 981; 901 | — |
| SECONDARY Maximum Measured Concentration of Midazolam in Plasma (Cmax) - Day 1 |
1090; 913; 1210; 934; 987 | — |
| SECONDARY Maximum Measured Concentration of Midazolam in Plasma (Cmax) - Day 14 |
1250; 1010; 1160; 1090; 931 | — |
| SECONDARY Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) - Day -1 |
2830; 1920; 3080; 2610; 2350 | — |
| SECONDARY Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) - Day 1 |
2760; 2020; 2720; 2290; 2360 | — |
| SECONDARY Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) - Day 14 |
3570; 2130; 2710; 2390; 2570 | — |
Summary
The main objectives of this trial are to investigate safety and tolerability of BI 474121 in healthy male and female young and elderly subjects following oral administration of multiple rising doses per day over 14 days.
Eligibility Criteria
Inclusion Criteria
- Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- Age of 18 to 45 years (inclusive) for young or 65 to 80 years (inclusive) for elderly healthy volunteers
- 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 GCP and local legislation
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 100 to 140 mm Hg, 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
- A positive Poly-chain reaction (PCR) test for SARS-CoV-2 and clinical symptoms suggestive for this disease at screening or on Day -3
- Further exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT04537897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.