The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics and pharmacodynamics of BI 3731579 in healthy volunteers following administration of multiple rising doses per day over 15 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Day 2 and Day 17: a single mid dose of BI 3731579, with 240 mL of water. Day 4 to Day 16: a double daily mid dose (bid) of BI 3731579 each day, with 240 mL of water.
Placebo-matching film-coated tablets of BI 3731579 on Day 2 and Day 4 to Day 17, orally, with 240 milliliters (mL) of water.
Day 1 and Day 17: 75 micrograms (μg) of Midazolam for injection, orally, with 240 mL of water, as a single dose.
SGS Life Science Services - Clinical Research
Edegem, Belgium
Occurrence of Any Treatment-emergent Adverse Event Assessed as Drug-related by the Investigator
The occurrence of any treatment-emergent adverse event (TEAE) assessed as drug-related by the investigator is reported as number of participants. The primary endpoint was analyzed without the microdose of midazolam on Day 1, as defined in the statistical analysis plan.
Time frame: From first drug administration on Day 2 until last drug administration on Day 17, plus residual effect period (REP) for each intervention. Up to 19 days.
Area Under the Concentration-time Curve of BI 3731579 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)
Area under the concentration-time curve of BI 3731579 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) after its last dose is reported. Timeframe: 0.5 hours before first BI 3731579 administration and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 359.75, 360.25, 360.5, 361, 361.5, 362, 364, 365, 367, 369, 371, 372, 384, and 408 thereafter.
Time frame: Up to 408 hours. Detailed timeframe in the description.
Maximum Measured Concentration of BI 3731579 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)
Maximum measured concentration of BI 3731579 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) after its last dose is reported. Timeframe: 0.5 hours before first BI 3731579 administration and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 359.75, 360.25, 360.5, 361, 361.5, 362, 364, 365, 367, 369, 371, 372, 384, and 408 thereafter.
Time frame: Up to 408 hours. Detailed timeframe in the description.
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Day 2 and Day 17: single low dose of BI 3731579 with 240 milliliters (mL) of water. Day 4 to Day 16: a double daily low dose (bid) of BI 3731579 each day, with 240 mL of water.
Day 2 and Day 17: single high dose of BI 3731579, with 240 mL of water. Day 4 to Day 16: a double daily high dose (bid) of BI 3731579 each day, with 240 mL of water.