Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: BI 425809 PfOS; Drug: BI 425809 tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02068690

2013-004937-34 (EudraCT Number)

1346.1

Details and patient eligibility

About

To investigate safety, tolerability, and pharmacokinetics of BI 425809 following single rising doses of BI 425809 in healthy male volunteers; To explore dose proportionality of BI 425809 as oral drinking solution; To investigate relative bioavailability of BI 425809 oral drinking solution fasted compared to BI 425809 tablet fasted and tablet fed

Enrollment: 83 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects
• Age 18 to 45 years (incl.)
• Body mass index (BMI) 18.5 to 29.9 kg/m2 (incl.)
• Subject must be able to understand and comply with study requirements

Exclusion criteria

• Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and judged clinically relevant by the investigator
• Repeated measurement of systolic blood pressure <90 or >140 mmHg, or diastolic blood pressure <50 or >90 mmHg, or pulse rate <50 or >90
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease judged clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)
• Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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83 participants in 2 patient groups

BI 425809 single rising dose

Experimental group

Description:

BI 425809 powder for oral solution (PfOS) in single rising doses

Treatment:

Drug: BI 425809 PfOS

Drug: Placebo

Drug: BI 425809 PfOS

Drug: Placebo

BI 425809 Crossover

Experimental group

Description:

Bioavailability of BI 425809 PfOS

Treatment:

Drug: BI 425809 tablet

Drug: BI 425809 PfOS

Drug: Placebo

Drug: BI 425809 PfOS

Drug: Placebo