NCT03505151

This Study in Healthy Men and Women Tests How the Body Takes up BI 409306

Completed Phase 1 Results posted Last updated 20 August 2024

What this trial tests

Phase 1 trial testing BI 409306 (C-13/N-15) in Healthy in 9 participants. Completed in 19 May 2018.

Timeline

27 April 2018

Primary endpoint
19 May 2018

19 May 2018

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	27 April 2018
Primary completion	19 May 2018
Estimated completion	19 May 2018
Sites	1 location across Germany

Drugs / interventions tested

• BI 409306 (C-13/N-15) — full drug profile →
• BI 409306 — full drug profile →

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 18 to 55, 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.

Area Under the Concentration-time Curve of BI 409306 and Stable Labelled Isotope BI 409306 (C-13/N-15) Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) Primary · T and R:Within 3 hours (h) before dosing, 0.75h, 0.97h, 1.333h, 1.75h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h and 24h after dosing. Only T: 0.17h, 0.333h, 0.47h. Only R:0.58h, 0.83h, 1.17h, 1.5h.

Area under the concentration-time curve of BI 409306 and stable labelled isotope BI 409306 (C-13/N-15) over the time interval from 0 extrapolated to infinity (AUC0-∞). The dose-normalized values for AUC0-∞ are reported.

Group	Value	95% CI
Test Treatment (T): BI 409306	NA	± NA
Reference Treatment (R): BI 409306 C-13/N-15	NA	± NA

Maximum Measured Concentration of BI 409306 and Stable Labelled Isotope BI 409306 (C-13/N-15), (Cmax) Primary · T and R:Within 3 hours (h) before dosing, 0.75h, 0.97h, 1.333h, 1.75h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h and 24h after dosing. Only T: 0.17h, 0.333h, 0.47h. Only R:0.58h, 0.83h, 1.17h, 1.5h.

Maximum measured concentration of the analyte BI 409306 and stable labelled isotope BI 409306 (C-13/N-15), (Cmax). The dose-normalized values for Cmax are reported.

Group	Value	95% CI
Test Treatment (T): BI 409306	NA	± NA
Reference Treatment (R): BI 409306 C-13/N-15	NA	± NA

Terminal Half-life of BI 409306 and Stable Labelled Isotope BI 409306 (C-13/N-15) in Plasma (t1/2) Secondary · T and R:Within 3 hours (h) before dosing, 0.75h, 0.97h, 1.333h, 1.75h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h and 24h after dosing. Only T: 0.17h, 0.333h, 0.47h. Only R:0.58h, 0.83h, 1.17h, 1.5h.

Terminal half-life of BI 409306 and stable labelled isotope BI 409306 (C-13/N-15) in plasma (t1/2) is reported.

Group	Value	95% CI
Test Treatment (T): BI 409306	1.49	± 23.1
Reference Treatment (R): BI 409306 C-13/N-15	1.39	± 24.3

Time From Dosing to Maximum Measured Concentration of BI 409306 and Stable Labelled Isotope BI 409306 (C-13/N-15) in Plasma (Tmax) Secondary · T and R:Within 3 hours (h) before dosing, 0.75h, 0.97h, 1.333h, 1.75h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h and 24h after dosing. Only T: 0.17h, 0.333h, 0.47h. Only R:0.58h, 0.83h, 1.17h, 1.5h.

Time from dosing to maximum measured concentration of BI 409306 and stable labelled isotope BI 409306 (C-13/N-15) in plasma is reported.

Group	Value	95% CI
Test Treatment (T): BI 409306	0.333	0.333 – 1.75
Reference Treatment (R): BI 409306 C-13/N-15	0.467	0.333 – 0.467

For: BI 409306 (C-13/N-15): Total Clearance (CL) of BI 409306 (C-13/N-15) Secondary · Within 3 hours (h) before drug administration, 0.58h, 0.75h, 0.83h, 0.97h, 1.17h, 1.333h, 1.5h, 1.75h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h and 24h after dosing.

Total clearance (CL) of BI 409306 (C-13/N-15) is reported.

Group	Value	95% CI
Reference Treatment (R): BI 409306 C-13/N-15	825	± 33.6

For BI 409306 (C-13/N-15): Apparent Volume of Distribution During the Terminal Phase After Intravascular Administration (Vz) of BI 409306 (C-13/N-15) Secondary · Within 3 hours (h) before drug administration, 0.58h, 0.75h, 0.83h, 0.97h, 1.17h, 1.333h, 1.5h, 1.75h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h and 24h after dosing.

Apparent volume of distribution during the terminal phase after intravascular administration of BI 409306 (C-13/N-15) is reported.

Group	Value	95% CI
Reference Treatment (R): BI 409306 C-13/N-15	98.9	± 21.5

Absolute Bioavailability of BI 409306 (Fabs) Secondary · T and R:Within 3 hours (h) before dosing, 0.75h, 0.97h, 1.333h, 1.75h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h and 24h after dosing. Only T: 0.17h, 0.333h, 0.47h. Only R:0.58h, 0.83h, 1.17h, 1.5h.

The evaluation of the absolute bioavailability (Fabs) of BI 409306 was performed by calculating the ratio between the area under the concentration-time curve over the time interval from 0 extrapolated to infinity (AUC0-∞) determined for the oral treatment (T) and the (AUC0-∞) determined for the i.v. infusion (R), corrected by the respective dose, and multiplied by 100.

Group	Value	95% CI
BI 409306 Tablet + Intravenous Isotope BI 409306 (C-13/N-15)	44.6	± 54.0

Adverse events — posted to ClinicalTrials.gov

Time frame: From first drug administration until 24 hours after the last oral drug administration, up to 2 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BI 409306 Tablet + Intravenous Isotope BI 409306 (C-13/N-15)

Serious: 0/9 (0%)

Deaths: 0/9

Other adverse events (3 terms — click to expand)

Reaction	System	BI 409306 Tablet + Intrave…
Visual impairment	Eye disorders	—
Chromatopsia	Eye disorders	—
Erythropsia	Eye disorders	—

Data from ClinicalTrials.gov NCT03505151 adverse events section.

Sponsor's own description

The primary objective of this trial is to investigate the absolute bioavailability of BI 409306. The secondary objective is the evaluation and comparison of several pharmacokinetic parameters for the different treatments.

Publications & conference data

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