NCT03793621

This Study is Done in Healthy Japanese Volunteers. It Looks at How Different Doses of BI 730357 Are Taken up in the Body and How Well They Are Tolerated

Completed Phase 1 Results posted Last updated 12 July 2023

What this trial tests

Phase 1 trial testing BI 730357 in Healthy in 24 participants. Completed in 26 April 2019.

Timeline

21 January 2019

Primary endpoint
26 April 2019

26 April 2019

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	24
Start date	21 January 2019
Primary completion	26 April 2019
Estimated completion	26 April 2019
Sites	1 location across Japan

Drugs / interventions tested

• BI 730357 — full drug profile →
• Placebo

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 20 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.

Number of Participants With Drug-related Adverse Events Primary · Up to 7 days after drug administration.

Number of participants with trial drug-related adverse events.

Group	Value	95% CI
Placebo	0
50 mg BI 730357 Single Dose	0
100 mg BI 730357 Single Dose	0
200 mg BI 730357 Single Dose	0

Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity Secondary · Within 3 hours before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 and 168 hours after drug administration.

Area under the concentration-time curve of BI 730357 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).

Group	Value	95% CI
50 mg BI 730357 Single Dose	7160	± 14.3
100 mg BI 730357 Single Dose	13000	± 48.6
200 mg BI 730357 Single Dose	13200	± 53.1

Maximum Measured Concentration of BI 730357 in Plasma Secondary · Within 3 hours before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 and 168 hours after drug administration.

Maximum measured concentration of BI 730357 in plasma (Cmax).

Group	Value	95% CI
50 mg BI 730357 Single Dose	346	± 23.0
100 mg BI 730357 Single Dose	451	± 34.8
200 mg BI 730357 Single Dose	515	± 48.2

Adverse events — posted to ClinicalTrials.gov

Time frame: [Serious and Other Adverse Events]: Up to 7 days after drug administration. [All-cause mortality]: From drug administration until end of trial, up to 13 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/6 (0%)

Deaths: 0/6

50 mg BI 730357 Single Dose

Serious: 0/6 (0%)

Deaths: 0/6

100 mg BI 730357 Single Dose

Serious: 0/6 (0%)

Deaths: 0/6

200 mg BI 730357 Single Dose

Serious: 1/6 (17%)

Deaths: 0/6

Total

Serious: 1/24 (4%)

Deaths: 0/24

Serious adverse events (1 terms)

Reaction	System	Placebo	50 mg BI 730357 Single Dose	100 mg BI 730357 Single Dose	200 mg BI 730357 Single Dose	Total
Appendicitis	Infections and infestations	—	—	—	—	—

Most-reported serious reactions: Appendicitis.

Data from ClinicalTrials.gov NCT03793621 adverse events section.

Sponsor's own description

The main objective of this trial is to investigate the safety and tolerability of BI 730357 in Japanese healthy male subjects following oral administration of single rising doses.

Secondary objectives are the explorations of the pharmacokinetic(s) (PK), including dose proportionality as well as investigation of linearity of BI 730357 after single dose administration.

Publications & conference data

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