Adults 18 to 70, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Treatment-emergent Drug-related Adverse Events (AEs)Primary· 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.
Group
Value
95% CI
Placebo/Placebo+ Midazolam
4.5
Midazolam Alone
0
10 mg BI 1323495 Bid EM
22.2
10 mg BI 1323495 Bid PM
0
30 mg BI 1323495 Bid EM
33.3
30 mg BI 1323495 Bid PM
16.7
70 mg BI 1323495 Bid + Midazolam EM
11.1
120 mg BI 1323495 Bid + Midazolam EM
22.2
120 mg BI 1323495 qd EM
0
150 mg BI 1323495 Bid + Midazolam EM
44.4
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)Secondary· 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.
Group
Value
95% CI
10 mg BI 1323495 Bid EM
118
± 56.1
10 mg BI 1323495 Bid PM
430
± 27.2
30 mg BI 1323495 Bid EM
282
± 66.2
30 mg BI 1323495 Bid PM
1310
± 29.1
70 mg BI 1323495 Bid + Midazolam EM
702
± 48.6
120 mg BI 1323495 Bid + Midazolam EM
982
± 76.2
120 mg BI 1323495 qd EM
784
± 81.7
150 mg BI 1323495 Bid + Midazolam EM
NA
± NA
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)Secondary· 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.
Group
Value
95% CI
120 mg BI 1323495 qd EM
1550
± 75.6
Maximum Measured Concentration of BI 1323495 in Plasma After the First Dose (Cmax)Secondary· 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.
Group
Value
95% CI
10 mg BI 1323495 Bid EM
23.5
± 31.4
10 mg BI 1323495 Bid PM
85.3
± 30.1
30 mg BI 1323495 Bid EM
62.0
± 57.1
30 mg BI 1323495 Bid PM
216
± 39.7
70 mg BI 1323495 Bid + Midazolam EM
123
± 50.0
120 mg BI 1323495 Bid + Midazolam EM
152
± 67.5
120 mg BI 1323495 qd EM
125
± 98.1
150 mg BI 1323495 Bid + Midazolam EM
109
± 77.8
Area Under the Concentration-time Curve of BI 1323495 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)Secondary· 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.
Group
Value
95% CI
10 mg BI 1323495 Bid EM
237
± 60.8
10 mg BI 1323495 Bid PM
738
± 22.8
30 mg BI 1323495 Bid EM
475
± 86.2
30 mg BI 1323495 Bid PM
2370
± 28.1
70 mg BI 1323495 Bid + Midazolam EM
2490
± 59.4
120 mg BI 1323495 Bid + Midazolam EM
2850
± 69.4
120 mg BI 1323495 qd EM
1960
± 55.9
150 mg BI 1323495 Bid + Midazolam EM
2070
± 41.5
Maximum Measured Concentration of BI 1323495 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)Secondary· 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.
Group
Value
95% CI
10 mg BI 1323495 Bid EM
37.5
± 49.6
10 mg BI 1323495 Bid PM
109
± 27.7
30 mg BI 1323495 Bid EM
64.4
± 78.7
30 mg BI 1323495 Bid PM
300
± 32.6
70 mg BI 1323495 Bid + Midazolam EM
281
± 48.0
120 mg BI 1323495 Bid + Midazolam EM
362
± 77.7
120 mg BI 1323495 qd EM
164
± 48.7
150 mg BI 1323495 Bid + Midazolam EM
265
± 46.0
Adverse events — posted to ClinicalTrials.gov
Time frame: 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..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 22 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04107805.