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

Safety, Pharmacodynamics, and Pharmacokinetics After Multiple Oral Doses of 200 and 300 mg BIIB 722 CL Tablet Tid and 300 and 450 mg BIIB 722 CL Tablet Bid Over 7 Days to Healthy Volunteer Subjects. An Open Study, Placebo-controlled Randomised Double Blind at Each Dose Level.

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

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: BIIB 722 CL

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: BIIB 722 CL	Drug: BIIB 722 CL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	assessed by AUC	up to day 7
Accumulation factor	(predose concentration/concentration after 8 hours)	up to day 7
Time to reach steady state		up to day 7
Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery	in vitro fluorescence	up to day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: August 21, 2014
• First Submitted That Met QC Criteria: October 16, 2014
• First Posted (Estimate): October 20, 2014

Study Record Updates

• Last Update Posted (Estimate): October 20, 2014
• Last Update Submitted That Met QC Criteria: October 16, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 1180.2