Phase 1
N=18
Pharmacokinetics of BI 409306 After a High Fat, High Caloric Meal and After a Single Oral Dose Given at Bed Time in Healthy Volunteers
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02222168 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Maximum Measured Concentration of BI 409306 in Plasma (Cmax) — 183; 175; 150 Nanomole per litre
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 409306 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Measured Concentration of BI 409306 in Plasma (Cmax) |
183; 175; 150 | — |
| PRIMARY Area Under the Concentration-time Curve of BI 409306 in Plasma From Time 0 to Time of Last Quantifiable Data Point (AUC0-tz) |
273; 293; 259 | — |
| SECONDARY Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) |
273; 293; 259 | — |
Summary
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.
Eligibility Criteria
Inclusion criteria
- Healthy male and female volunteers
- Age 18 (incl.) to 50 (incl.) years
- Body mass index (BMI) range: 18.5 (incl.) to 29.9 (incl.) kg/m2
Exclusion criteria
- Any evidence of a clinically relevant concomitant disease
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders)
- History or evidence of relevant orthostatic reaction, fainting spells or blackouts, occurrence of syncopes, brady- or tachycardia in the anamnesis.
- Positive pregnancy test
- 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)
Data sourced from ClinicalTrials.gov (NCT02222168). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.