A Study in Healthy Chinese People to Test How Different Doses of BI 1015550 Are Taken up in the Body

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1015550

• Registration Number: NCT05633862
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objectives of this trial are to investigate pharmacokinetics, safety and tolerability of BI 1015550 in Chinese healthy male and female subjects following administration of single doses.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2022-11-22
• Study First Posted: 2022-12-01
• Study Start: 2023-01-13
• Primary Completion: 2023-03-16
• Study Completion: 2023-03-17
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-10
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 1015550 low dose	BI 1015550	-
BI 1015550 high dose	BI 1015550	-

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	up to 7 days
Maximum measured concentration of the analyte in plasma (Cmax)	up to 7 days

Secondary Outcome Measures

Name	Time	Method
Occurrence of any treatment-emergent adverse events, assessed as the percentage of subjects treated with investigational drug who experience such an event	up to 14 days

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China