Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 Powder for Oral Solution

Boehringer Ingelheim24 enrolled

Overview

To investigate safety, tolerability, and pharmacokinetics of multiple rising oral doses of BI 1015550 in healthy male volunteers

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

PlaceboDRUG

Placebo to BI 1015550

BI 1015550DRUG

medium dose 1 powder for oral solution

BI 1015550DRUG

medium dose 2 powder for oral solution

BI1015550

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: 1\. Healthy male subjects Exclusion criteria: 1. Any relevant deviation from healthy conditions 2. Subjects unable to understand or to comply with study requirements

Locations (1)

1305.2.1 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Outcomes

Primary Outcomes

Percentage of Subjects With Drug-related Adverse Events

Percentage of subjects with drug related Adverse events, as assessed by the investigator.

Time frame: From first drug administration until last drug administration, upto 18 days.

Secondary Outcomes

Cmax

Maximum measured concentration of BI 1015550 in plasma.

Time frame: 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.

AUCt,1

Area under the concentration-time curve of BI 1015550 in plasma over a uniform dosing interval t after administration of the first dose

Time frame: 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h and 12h after first drug administration

AUC0-infinity

Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity.

Time frame: 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.

Cmax,ss

Maximum measured concentration of BI 1015550 in plasma at steady state over a uniform dosing interval t.

Time frame: 311:55h (hours); 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h; 324h; 336h; 346h; 360h; 384h & 408h after first drug administration; last drug administration was at 312 h.

AUCt,ss

Area under the concentration-time curve of BI 1015550 in plasma at steady state over a uniform dosing interval t.

Time frame: 311:55h; 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h and 324h after first drug administration; last drug administration was at 312 h.

Data from ClinicalTrials.gov

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