Tolerability and Pharmacokinetics of BIIB 722 CL Drinking Solution and of BIIB 722 CL Filmcoated Tablet in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BIIB 722 CL solution; Drug: Placebo tablet; Drug: Placebo solution; Drug: BIIB 722 CL tablet

• Registration Number: NCT02227030
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Safety and pharmacokinetics after oral single rising doses of BIIB 722 CL

Detailed Description

Not available

Study Timeline

• Study Start: 2000-04
• Primary Completion: 2000-09
• Status Verified: 2014-08
• Study First Submitted: 2014-08-26
• Study First Submitted QC: 2014-08-26
• Last Update Submitted: 2014-08-26
• Study First Posted: 2014-08-27
• Last Update Posted: 2014-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 71

Inclusion Criteria

• Healthy males
• 18 to 55 years of age
• Broca index >= -20% and <= +20%
• Written informed consent according to Good Clinical Practice (GCP) and local legislation

Exclusion Criteria

• Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
• History or current gastrointestinal hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
• History of orthostatic hypotension, fainting spells or blackouts
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
• Use of any drugs, which might influence the results of the trial within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within 2 months prior to administration or during trial
• Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
• Alcohol abuse (> 60g/day)
• Drug abuse
• Blood donation within 1 month prior to administration or during the trial
• Excessive physical activities within 5 days prior to administration or during the trial
• Any laboratory value outside the clinically accepted reference range

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BIIB 722 CL single rising dose	BIIB 722 CL solution	-
BIIB 722 CL cross over	BIIB 722 CL solution	-
Placebo tablet	Placebo tablet	-
BIIB 722 CL cross over	BIIB 722 CL tablet	-
Placebo solution	Placebo solution	-

Primary Outcome Measures

Name	Time	Method
Total clearance of the analyte in plasma (CLtot/f)	up to 96 hours after drug administration
Maximum measured concentration of the analyte in plasma (Cmax)	up to 96 hours after drug administration
Area under the concentration-time curve of the analyte in plasma (AUC)	up to 96 hours after drug administration
Time from dosing to the maximum concentration of the analyte in plasma (tmax)	up to 96 hours after drug administration
Total mean residence time of the analyte in the body (MRTtot)	up to 96 hours after drug administration

Secondary Outcome Measures

Name	Time	Method
Number of subjects with adverse events	up to 96 hours after drug administration
Number of subjects with clinically significant findings in vital functions	up to 96 hours after drug administration
Number of subjects with clinically significant findings in laboratory tests	up to 96 hours after drug administration
Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery	up to 24 hours after drug administration