Pharmacokinetics of BI 409306 After a High Fat, High Caloric Meal and After a Single Oral Dose Given at Bed Time in Healthy Volunteers

Boehringer Ingelheim18 enrolled

Overview

To evaluate the effect of food on the pharmacokinetics of BI 409306 and to investigate the pharmacokinetics of BI 409306 when given at bed time.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

BI 409306DRUG

film-coated tablet

Eligibility

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

Medical Language ↔ Plain English

Inclusion criteria: 1. Healthy male and female volunteers 2. Age 18 (incl.) to 50 (incl.) years 3. Body mass index (BMI) range: 18.5 (incl.) to 29.9 (incl.) kg/m2 Exclusion criteria: 1. Any evidence of a clinically relevant concomitant disease 2. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance 3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 4. Surgery of the gastrointestinal tract (except appendectomy) 5. Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders) 6. History or evidence of relevant orthostatic reaction, fainting spells or blackouts, occurrence of syncopes, brady- or tachycardia in the anamnesis. 7. Positive pregnancy test 8. No adequate contraception during the study and until 1 month of study completion, i.e. intrauterine device (IUD), sexual abstinence (for at least 1 month prior to enrolment), or surgical sterilisation (incl. hysterectomy). Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)

Locations (1)

1289.22.1 Boehringer Ingelheim Investigational Site

Berlin, Germany

Outcomes

Primary Outcomes

Maximum Measured Concentration of BI 409306 in Plasma (Cmax)

Cmax is the maximum measured concentration of BI 409306 in plasma. More detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C

Time frame: Treatment A/B: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h; treatment C: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h

Area Under the Concentration-time Curve of BI 409306 in Plasma From Time 0 to Time of Last Quantifiable Data Point (AUC0-tz)

AUC0-tz is the area under the concentration-time curve of the BI 409306 in plasma from time 0 to time of last quantifiable data point. More detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C

Secondary Outcomes

Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)

AUC0-infinity is the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. More detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C.

Data from ClinicalTrials.gov

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