Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02068690
• Collaborator: (none)
• Enrollment: 83
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 13.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BI 425809 PfOS; Drug: Placebo; Drug: Placebo; Drug: BI 425809 tablet; Drug: BI 425809 PfOS	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 83 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 425809 in Healthy Male Subjects (Partially Randomised, Single-blind, Placebo-controlled) and Investigation of Relative Bioavailability and Food Effect of BI 425809 (Open-label, Randomised, Three-way Crossover)
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BI 425809 single rising dose BI 425809 powder for oral solution (PfOS) in single rising doses	Drug: BI 425809 PfOS; BI 425809 PfOS; Drug: Placebo; Placebo
Experimental: BI 425809 Crossover Bioavailability of BI 425809 PfOS	Drug: Placebo; Placebo; Drug: BI 425809 tablet; BI 425809 tablet; Drug: BI 425809 PfOS; BI 425809 PfOS

Outcome Measures

Primary Outcome Measures

1. frequency [N(%)] of subjects with drug related adverse events (AEs) [up to 18 days]

Secondary Outcome Measures

1. Cmax (maximum measured concentration of the analyte in plasma) [up to 192 hours]

2. AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [up to 192 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1346.1.1 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: NCT02068690
• Other Study ID Numbers: 1346.1; 2013-004937-34
• First Posted: Feb 21, 2014
• Last Update Posted: Oct 8, 2014
• Last Verified: Oct 1, 2014

• Additional relevant MeSH terms: BI 425809

Study Results

No Results Posted as of Oct 8, 2014