NCT02597998

Metabolism and Pharmacokinetics of [14C]-BI 409306 After Administration as Oral Solution in Healthy Male Volunteers

Completed Phase 1 Results posted Last updated 7 March 2024

What this trial tests

Phase 1 trial testing 14C-BI 409306 in Healthy in 6 participants. Completed in 11 December 2015.

Timeline

15 September 2015

Primary endpoint
11 December 2015

11 December 2015

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	6
Start date	15 September 2015
Primary completion	11 December 2015
Estimated completion	11 December 2015
Sites	1 location across United Kingdom

Drugs / interventions tested

• 14C-BI 409306 — full drug profile →

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 30 to 65, 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.

Mass Balance Recovery of Total Radioactivity in Urine and Faeces: Amount Excreted Within the Time Interval From 0 to the Time of the Last Quantifiable Data Point as a Percentage of the Administered Dose (fe0-tz) for Urine and Faeces Primary · Urine and faeces sample collection: 17 hours before and up to 216 hours after drug administration. The details are mentioned in description section.

Mass balance recovery of total radioactivity in urine and faeces: Amount excreted within the time interval from 0 to the time of the last quantifiable data point as a percentage of the administered dose (fe0-tz) for urine and faeces. Urine collection intervals: -17:00-0:00 hours before drug administration and, 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192 and 192-216 hours after drug administration. Faeces collection intervals: -17:00-0:00, 0-24, 24-48, 48-72, 72-96, 96- 20, 120-144, 144-168, 168-192 and 192-216 hours after drug administration.

Urine

Group	Value	95% CI
14C-BI 409306 - 25 mg	84.0	± 4.42

Faeces

Group	Value	95% CI
14C-BI 409306 - 25 mg	10.4	± 10.5

Urine and Faeces

Group	Value	95% CI
14C-BI 409306 - 25 mg	94.4	± 4.45

Maximum Measured Concentration of BI 409306 in Plasma (Cmax) Secondary · PK plasma samples were taken at: 2:00 (hour: minute) before drug administration and 0:10, 0:20, 0:30, 0:45, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 hours after drug administration.

Maximum measured concentration of BI 409306 in plasma (Cmax).

Group	Value	95% CI
14C-BI 409306 - 25 mg	275	± 24.3

Maximum Measured Concentration of 14C-BI 409306 Related Radioactivity in Plasma (Cmax) Secondary · PK plasma samples were taken at: 2:00 (hour: minute) before drug administration and 0:10, 0:20, 0:30, 0:45, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 hours after drug administration.

Maximum measured concentration of 14C-BI 409306 related radioactivity in plasma (Cmax).

Group	Value	95% CI
14C-BI 409306 - 25 mg	1600	± 15.6

Area Under the Concentration-time Curve Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) for BI 409306 in Plasma Secondary · PK plasma samples were taken at: 2:00 (hour: minute) before drug administration and 0:10, 0:20, 0:30, 0:45, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 hours after drug administration.

Area under the concentration-time curve over the time interval from 0 to the last quantifiable data point (AUC0-tz) for BI 409306 in plasma.

Group	Value	95% CI
14C-BI 409306 - 25 mg	357	± 36.8

Area Under the Concentration-time Curve Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) for 14C-BI 409306 Related Radioactivity in Plasma Secondary · PK plasma samples were taken at: 2:00 (hour: minute) before drug administration and 0:10, 0:20, 0:30, 0:45, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 hours after drug administration.

Area under the concentration-time curve over the time interval from 0 to the last quantifiable data point (AUC0-tz) for 14C-BI 409306 related radioactivity in plasma.

Group	Value	95% CI
14C-BI 409306 - 25 mg	3560	± 9.6

Adverse events — posted to ClinicalTrials.gov

Time frame: From first drug administration until 7 days after the last drug administration, up to 21 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

14C-BI 409306 - 25 mg

Serious: 0/6 (0%)

Deaths: —

Other adverse events (1 terms — click to expand)

Reaction	System	14C-BI 409306 - 25 mg
Headache	Nervous system disorders	—

Data from ClinicalTrials.gov NCT02597998 adverse events section.

Sponsor's own description

The aim of this study is to assess the mass balance recovery from excreta of carbon 14 labelled BI409306 (\[14C\] BI 409306) in healthy, CYP2C19 genotyped subjects and to provide plasma, urine and faecal samples for metabolite profiling and structural identification.

Publications & conference data

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