Relative Bioavailability of a Single Oral Dose of BI 425809 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 13 April 2015
• Main ID: NCT02342717
• Date of registration: 15/01/2015
• Prospective Registration: No
• Primary sponsor: Boehringer Ingelheim
• Public title: Relative Bioavailability of a Single Oral Dose of BI 425809 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects
• Scientific title: Relative Bioavailability of a Single Oral Dose of BI 425809 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)
• Date of first enrolment: January 2015
• Target sample size: 16
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02342717
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

Inclusion criteria:

- Healthy male subjects according to the investigator's assessment, based on a complete
medical history including a physical examination, vital signs (BP, PR), 12-lead ECG,
and clinical laboratory tests

- Age of 18 to 50 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 GCP and local legislation

Exclusion criteria:

- Any finding in the medical examination (including BP, PR or ECG) is deviating from
normal and judged as clinically relevant by the investigator

- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg,
diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside
the range of 50 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)

- Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10
halflives of the respective drug prior to administration of trial medication

- Within 10 days prior to administration of trial medication, use of drugs that might
reasonably influence the results of the trial or that might prolong the QT/QTc
interval

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

- 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 30 g per day)

- 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) or any other relevant 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

- Male subjects who do not agree to minimize the risk of female partners becoming
pregnant from the first dosing day until two month after the trial completion.
Acceptable methods of contraception comprise barrier contraception and a medically
accepted contraceptive method for the female partner (intra-uterine device with
spermicide, hormonal contraceptive for at least two month prior trial participation)

- Known fructose intolerance, glucose-galactose malabsorption, or saccharose-isomaltase
deficiency

- History of relevant liver diseases such as disturbance of liver function, jaundice,
drug induced liver injury, Dubin-Johnson syndrome, Rotor syndrome, or liver tumours

- Liver enzymes (ALT, AST, GGT) above upper limit of normal at the screening
examination



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Itraconazole

Drug: BI 425809

Primary Outcome(s)

AUC0-167 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 167 h) [Time Frame: 8 days postdose]

Cmax (maximum measured concentration of the analyte in plasma) [Time Frame: 15 days postdose]

Secondary Outcome(s)

AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [Time Frame: 15 days postdose]

Secondary ID(s)

2014-004855-29

1346.10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors