A Study in Healthy Men and Women to Test How Well Different Doses of BI 1323495 Are Tolerated
- Registration Number
- NCT04107805
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objective of this trial is to investigate the safety and tolerability of BI 1323495 in healthy subjects following bid oral administration of multiple rising doses, each over an 11 day treatment period.
Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality (only for Part 1) as well as attainment of steady state. This includes exploration of a therapeutic exposure range, a range not adequately achieved in the single-rising dose trial 1405-0001.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 87
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description 120 mg BI 1323495 qd EM BI 1323495 - Placebo/Placebo+ Midazolam Midazolam - 10 mg BI 1323495 bid EM BI 1323495 - 10 mg BI 1323495 bid PM BI 1323495 - Placebo/Placebo+ Midazolam Placebo - 70 mg BI 1323495 bid + Midazolam EM Midazolam - 120 mg BI 1323495 bid + Midazolam EM BI 1323495 - 120 mg BI 1323495 bid + Midazolam EM Midazolam - 150 mg BI 1323495 bid + Midazolam EM Midazolam - 30 mg BI 1323495 bid EM BI 1323495 - 30 mg BI 1323495 bid PM BI 1323495 - 70 mg BI 1323495 bid + Midazolam EM BI 1323495 - 150 mg BI 1323495 bid + Midazolam EM BI 1323495 -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Treatment-emergent Drug-related Adverse Events (AEs) Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Percentage of participants with treatment-emergent drug-related Adverse Events (AEs) is reported.
Percentages are calculated using total number of subjects per treatment as the denominator.
- Secondary Outcome Measures
Name Time Method Area Under the Concentration-time Curve of BI 1323495 in Plasma Over a Time Interval of 12 h After Administration of the First Dose (AUC0-12) Within 3 hours before and 20 minutes (min), 40 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, and 12h after the first administration of BI 1323495 on Day 1. Area under the concentration-time curve of BI 1323495 in plasma over a time interval of 12 h after administration of the first dose (AUC0-12) is reported.
Only for Once Daily (qd) Dosing Group: Area Under the Concentration-time Curve of BI 1323495 in Plasma Over a Uniform Dosing Interval of 24 h After Administration of the First Dose (AUC0-24) Within 3 hours before and 20 minutes (min), 40 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h and 24 h after administration of BI 1323495 on Day 1. Area under the concentration-time curve of BI 1323495 in plasma over a uniform dosing interval of 24 h after administration of the first dose (AUC0-24) for the once daily (qd) dosing group is reported.
Maximum Measured Concentration of BI 1323495 in Plasma After the First Dose (Cmax) Within 3 hours before and 20 minutes (min), 40 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h and 24h* after the first administration of BI 1323495 on Day 1. * Applicable only for the 120 mg BI 1323495 qd EM arm. Maximum measured concentration of BI 1323495 in plasma after the first dose (Cmax) is reported.
Area Under the Concentration-time Curve of BI 1323495 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) Within 3 hours before and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h and 24h* after the last administration of BI 1323495 on Day 11. * Applicable only for the 120 mg BI 1323495 qd EM arm. Area under the concentration-time curve of BI 1323495 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) is reported. The dosing interval τ is not the same for all groups. The dosing interval is 12 hours (h) for the dose groups with a twice daily (bid) BI 1323495 administration and 24 h for the dose group with a once daily (qd) BI 1323495 administration.
Maximum Measured Concentration of BI 1323495 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) Within 3 hours before and 20 min, 40 min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h and 24h* after the last drug administration of BI 1323495 on Day 11. * Applicable only for the 120 mg BI 1323495 qd EM arm. Maximum measured concentration of BI 1323495 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) is reported.
The dosing interval τ is not the same for all groups. The dosing interval is 12 hours (h) for the dose groups with a twice daily (bid) BI 1323495 administration and 24 h for the dose group with a once daily (qd) BI 1323495 administration.
Trial Locations
- Locations (1)
Fraunhofer ITEM
🇩🇪Hannover, Germany