Safety, Pharmacodynamics, and Pharmacokinetics After Multiple Different Oral Doses of BIIB 722 CL Tablets in Healthy Volunteers

Phase 1

Terminated

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

• Registration Number: NCT02268604
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to assess safety, pharmacodynamics and pharmacokinetics of BIIB 722 CL

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2010-10
• Study First Submitted: 2014-08-21
• Status Verified: 2014-10
• Study First Submitted QC: 2014-10-16
• Last Update Submitted: 2014-10-16
• Study First Posted: 2014-10-20
• Last Update Posted: 2014-10-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 10

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

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Exclusion Criteria

• Any finding of the medical examination (including blood pressure, pulse rate and 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 of during trial
• Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
• Alcohol abuse (> 60 g/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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
BIIB 722 CL	BIIB 722 CL	-

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the analyte in plasma (AUC)	up to day 7
Maximum measured concentration of the analyte in plasma (Cmax)	up to day 7
Time to maximum measured concentration of the analyte in plasma (tmax)	up to day 7
Total mean residence time of the analyte in the body (MRTtot)	up to day 7
Total clearance of the analyte in plasma (CLtot/f)	up to day 7
Terminal half-life of the analyte in plasma (t1/2)	up to day 7
Amount of the analyte excreted in urine (Ae)	up to day 7
Dose proportionality	up to day 7	assessed by AUC
Accumulation factor	up to day 7	(predose concentration/concentration after 8 hours)
Time to reach steady state	up to day 7
Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery	up to day 7	in vitro fluorescence

Secondary Outcome Measures

Name	Time	Method
Number of subjects with adverse events	up to day 12
Number of subjects with clinically significant findings in vital functions	up to day 12
Number of subjects with clinically significant findings in laboratory tests	up to day 12