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 Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 409306

Study type: Interventional

Funder types: Industry

Identifiers

NCT02222168

1289.22

2014-001934-28 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

BI 409306 fasted

Experimental group

Description:

Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fasted condition.

Treatment:

Drug: BI 409306

BI 409306 fed

Experimental group

Description:

Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fed condition.

Treatment:

Drug: BI 409306

BI 409306 at bed-time

Experimental group

Description:

Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water at bed-time.

Treatment:

Drug: BI 409306