Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809

Phase 1CompletedNCT02068690

Boehringer Ingelheim83 enrolled

Overview

To investigate safety, tolerability, and pharmacokinetics of BI 425809 following single rising doses of BI 425809 in healthy male volunteers; To explore dose proportionality of BI 425809 as oral drinking solution; To investigate relative bioavailability of BI 425809 oral drinking solution fasted compared to BI 425809 tablet fasted and tablet fed

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

BI 425809 PfOSDRUG

BI 425809 as a powder for an oral solution (PfOS)

Placebo PfOSDRUG

Placebo as a powder for an oral solution (PfOS)

BI 425809 tabletDRUG

BI 425809 as a tablet

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: * Healthy male subjects * Age 18 to 45 years (incl.) * Body mass index (BMI) 18.5 to 29.9 kg/m2 (incl.) * Subject must be able to understand and comply with study requirements Exclusion criteria: * Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and judged clinically relevant by the investigator * Repeated measurement of systolic blood pressure \<90 or \>140 mmHg, or diastolic blood pressure \<50 or \>90 mmHg, or pulse rate \<50 or \>90 * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance * Any evidence of a concomitant disease judged clinically relevant by the investigator * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s) * Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

Locations (1)

1346.1.1 Boehringer Ingelheim Investigational Site

Ingelheim, Germany

Outcomes

Primary Outcomes

Number of Participants With Drug-related Adverse Events (AE)

Number of participants with drug-related Adverse Events (AE). Drug-relatedness was assessed by the investigator.

Time frame: SRD Part: From the time of first drug administration until the end of study, up to 18 days. BA/FE Part: From the time of first drug administration until the end of the intervention period, up to 18 days for each intervention.

Secondary Outcomes

SRD Part: Maximum Concentration of BI 425809 in Plasma (Cmax)

Maximum measured concentration of BI 425809 in plasma (Cmax) in the Single Rising Dose (SRD) part of the trial is reported.

Time frame: 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.

BA/FE Part: Maximum Concentration of BI 425809 in Plasma (Cmax)

Maximum measured concentration of BI 425809 in plasma (Cmax) in the bioavailability/food effect (BA/FE) part of the trial is reported.

SRD Part: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC(0-∞))

Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC(0-∞)) in the Single Rising Dose (SRD) part of the trial is reported.

BA/FE Part: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC(0-∞))

Data from ClinicalTrials.gov

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