Safety, Tolerability, Pharmacokinetics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers, Including Investigation of the Effect of Food on the Bioavailability of BI 1181181

NCT ID: NCT02044406

Last Updated: 2014-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-09-30

Brief Summary

To investigate the safety, tolerability, pharmacokinetics (including dose proportionality assessment), and pharmacodynamics of single rising oral doses of BI 1181181 (Single rising dose (SRD) part) Secondly, to investigate the relative bioavailability of the tablet versus the powder for oral solution (PfOS) and the effect of food on the pharmacokinetics of BI 1181181 (Bioavailability/Food effect (BA/FE) part)

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1 BI 1181181 single rising dose part

single rising doses of BI 1181181

Group Type: EXPERIMENTAL

BI 1181181

Intervention Type: DRUG

single dose (low to high dose)

Placebo to BI 1181181

Intervention Type: DRUG

Placebo to BI 1181181

2 BI 1181181 bioavailability part

bioavailability, food effect part of BI 11881181

Group Type: EXPERIMENTAL

BI 1181181, R

Intervention Type: DRUG

powder for oral solution

BI 1181181, T2

Intervention Type: DRUG

tablet, fasted

BI 1181181, T1

Intervention Type: DRUG

tablet, fed

Interventions

BI 1181181

single dose (low to high dose)

Intervention Type: DRUG

BI 1181181, R

powder for oral solution

Intervention Type: DRUG

BI 1181181, T2

tablet, fasted

Intervention Type: DRUG

Placebo to BI 1181181

Placebo to BI 1181181

Intervention Type: DRUG

BI 1181181, T1

tablet, fed

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs blood pressure (BP), pulse rate (PR), 12-lead ECG, and clinical laboratory tests
• Age 18 to 50 years (incl.)
• Body mass index (BMI) 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) deviating from normal and judged clinically relevant by the investigator
• Repeated measurement of systolic blood pressure < 90 mmHg and >= 140 mmHg at screening
• Repeated measurement of diastolic blood pressure < 55 and >= 90 mmHg at screening
• Repeated measurement of pulse rate < 50 bpm and > 90 bpm at screening
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1344.1.1 Boehringer Ingelheim Investigational Site

Ingelheim, , Germany

Countries

Germany

Other Identifiers

2013-002868-88

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1344.1

Identifier Type: -

Identifier Source: org_study_id