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

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT02044406

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BI 1181181 Drug: BI 1181181, R Drug: BI 1181181, T2 Drug: Placebo to BI 1181181 Drug: BI 1181181, T1	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single

Primary Purpose:

Treatment

Official Title:

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers in a Partially Randomised, Single-blind, Placebo-controlled Trial, and Investigation of Relative Bioavailability and the Effect of Food on the Pharmacokinetics of BI 1181181(Open-label, Randomised, Three-way Cross-over Design)

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 BI 1181181 single rising dose part single rising doses of BI 1181181	Drug: BI 1181181 single dose (low to high dose) Drug: Placebo to BI 1181181 Placebo to BI 1181181
Experimental: 2 BI 1181181 bioavailability part bioavailability, food effect part of BI 11881181	Drug: BI 1181181, R powder for oral solution Drug: BI 1181181, T2 tablet, fasted Drug: BI 1181181, T1 tablet, fed

Arm

Intervention/Treatment

Experimental: 1 BI 1181181 single rising dose part

single rising doses of BI 1181181

Drug: BI 1181181

single dose (low to high dose)

Drug: Placebo to BI 1181181

Placebo to BI 1181181

Experimental: 2 BI 1181181 bioavailability part

bioavailability, food effect part of BI 11881181

Drug: BI 1181181, R

powder for oral solution

Drug: BI 1181181, T2

tablet, fasted

Drug: BI 1181181, T1

tablet, fed

Outcome Measures

Primary Outcome Measures

Number (%) of subjects with drug-related adverse events (AEs) [up to 72 h]
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) [up to 72 h]
Cmax (maximum measured concentration of the analyte in plasma) [up to 72 h]

Secondary Outcome Measures

Aet1-t2 (Amount of analyte that is eliminated in urine from the time point t1 to timepoint t2 after single dose administration) [up to 72 h]
Cmax (maximum measured concentration of the analyte in plasma) [up to 72 h]
tmax (time from dosing to maximum measured concentration of the analyte in plasma) [up to 72 h]
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [up to 72 h]
t1/2 (terminal half-life of the analyte in plasma) [up to 72 h]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1344.1.1 Boehringer Ingelheim Investigational Site	Ingelheim		Germany

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT02044406

Other Study ID Numbers:

1344.1
2013-002868-88

First Posted:

Jan 24, 2014

Last Update Posted:

Oct 8, 2014

Last Verified:

Oct 1, 2014

Study Results

No Results Posted as of Oct 8, 2014