Overview

Drug-drug Interaction (DDI) With a P-gp Inhibitor, Organic Anion Transporting Polypeptide OATP-inhibitor, Food Effect

Status:
Completed
Trial end date:
2017-05-31
Target enrollment:
0
Participant gender:
Male
Summary
The primary objective of this trial is to investigate the relative bioavailability of BI 685509 given alone under fasted conditions (Reference, R) compared to the intake after a high fat, high caloric breakfast (Test 1, T1), to combined administration with itraconazole under fasted conditions (Test 2, T2) and to combined administration with rifampin under fasted conditions (Test 3, T3). The secondary objective is the evaluation and comparison of several pharmacokinetic parameters between the treatments.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Hydroxyitraconazole
Itraconazole
Rifampin
Criteria
Inclusion Criteria:

- Healthy male subjects according to the investigators assessment, based on a complete
medical history including a physical examination, vital signs (Blood Pressure [BP],
Pulse Rate [PR]), 12 lead Electrocardiogram [ECG], and clinical laboratory tests

- Age of 18 to 55 years (incl.)

- Body Mass Index [BMI] of 18.5 to 29.9 kg/m2 (incl.)

- Signed and dated written informed consent prior to admission to the study in
accordance with Good Clinical Practice [GCP] and local legislation

Exclusion Criteria:

- Any finding in the medical examination (including Blood Pressure [BP], Pulse Rate [PR]
or Electrocardiogram [ECG]) is deviating from normal and judged as clinically relevant
by the investigator

- Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg,
diastolic blood pressure outside the range of 60 to 90 mmHg, or pulse rate outside the
range of 45 to 90 bpm

- Any laboratory value outside the reference range that the investigator considers to be
of clinical relevance

- Any evidence of a concomitant disease judged as clinically relevant by the
investigator

- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
immunological or hormonal disorders

- Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with
the pharmacokinetics of the trial medication (except appendectomy and simple hernia
repair)

- Diseases of the central nervous system (including but not limited to any kind of
seizures or stroke), and other relevant neurological or psychiatric disorders

- History of relevant orthostatic hypotension, fainting spells, or blackouts

- Chronic or relevant acute infections

- History of relevant allergy or hypersensitivity (including allergy to the trial
medication or its excipients)

- Use of drugs within 30 days prior to administration of trial medication if that might
reasonably influence the results of the trial (incl. Time between start of the Q-wave
and the end of the T-wave in an electrocardiogram/ corrected QT interval [QT/QTc]
interval prolongation)

- Participation in another trial where an investigational drug has been administered
within 60 days prior to planned administration of trial medication, or current
participation in another trial involving administration of investigational

- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)

- Inability to refrain from smoking on specified trial days

- Alcohol abuse (consumption of more than 24 g per day for males)

- Drug abuse or positive drug screening

- Blood donation of more than 100 mL within 30 days prior to administration of trial
medication or intended donation during the trial

- Intention to perform excessive physical activities within one week prior to
administration of trial medication or during the trial

- Inability to comply with dietary regimen of trial site

- A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are
repeatedly greater than 450 ms in males or any other relevant Electrocardiogram [ECG]
finding at screening

- A history of additional risk factors for Torsades de Pointes (such as heart failure,
hypokalemia, or family history of Long QT Syndrome)

- Subject is assessed as unsuitable for inclusion by the investigator, for instance,
because considered not able to understand and comply with study requirements, or has a
condition that would not allow safe participation in the study