NCT03802331

A Study to Test How Food Influences the Amount of BI 1323495 in the Blood of Healthy Men

Completed Phase 1 Results posted Last updated 22 February 2024

What this trial tests

Phase 1 trial testing BI 1323495, in Healthy in 12 participants. Completed in 3 March 2019.

Timeline

28 January 2019

Primary endpoint
3 March 2019

3 March 2019

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	28 January 2019
Primary completion	3 March 2019
Estimated completion	3 March 2019
Sites	1 location across Germany

Drugs / interventions tested

• BI 1323495,

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 18 to 45, male only, 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.

Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point Primary · Within 2 hours before and then 20 minutes (min), 40 min, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72 and 96 hours after drug administration

Area under the concentration-time curve of BI 1323495 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. Confidence intervals were calculated based on the residual error from the ANOVA.

Group	Value	95% CI
BI 1323495 Fed (T)	NA	± NA
BI 1323495 Fasted (R)	NA	± NA

Maximum Measured Concentration of BI 1323495 in Plasma Primary · Within 2 hours before and then 20 minutes (min), 40 min, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72 and 96 hours after drug administration

Maximum measured concentration of BI 1323495 in plasma (Cmax). The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. Confidence intervals were calculated based on the residual error from the ANOVA.

Group	Value	95% CI
BI 1323495 Fed (T)	NA	± NA
BI 1323495 Fasted (R)	NA	± NA

Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 Extrapolated to Infinity Secondary · Within 2 hours before and then 20 minutes (min), 40 min, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72 and 96 hours after drug administration

Area under the concentration-time curve of BI 1323495 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. Confidence intervals were calculated based on the residual error from the ANOVA.

Group	Value	95% CI
BI 1323495 Fed (T)	NA	± NA
BI 1323495 Fasted (R)	NA	± NA

Adverse events — posted to ClinicalTrials.gov

Time frame: From drug administration until the next drug administration or end of trial, up to 14 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BI 1323495 Fed (T)

Serious: 0/11 (0%)

Deaths: 0/11

BI 1323495 Fasted (R)

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (4 terms — click to expand)

Reaction	System	BI 1323495 Fed (T)	BI 1323495 Fasted (R)
Influenza	Infections and infestations	—	—
Otitis externa	Infections and infestations	—	—
Mouth injury	Injury, poisoning and procedural complications	—	—
Headache	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT03802331 adverse events section.

Sponsor's own description

The main objective of this trial is to assess the effect of food on the pharmacokinetics of an oral tablet formulation of BI 1323495 by investigating the relative bioavailability following single dose administration under fed and fasted conditions.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.