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

Tolerability and Pharmacokinetics of Single Oral Administration of 10, 20, 50, 100, 200 and 300 mg BIIB 722 CL (Calculated as Free Base) as Drinking Solution and of 200, 450, 600 and 750 mg BIIB 722 CL as Filmcoated Tablet in Healthy Subjects. An Open Study With Rising Doses, Partly Uncontrolled Intra-individual Comparison, Placebo Randomised Double Blind at Each Dose Level.

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo tablet; Drug: Placebo solution; Drug: BIIB 722 CL solution; Drug: BIIB 722 CL tablet

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• 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 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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo tablet	Drug: Placebo tablet
Experimental: BIIB 722 CL single rising dose	Drug: BIIB 722 CL solution
Experimental: BIIB 722 CL cross over	Drug: BIIB 722 CL solution; Drug: BIIB 722 CL tablet
Placebo Comparator: Placebo solution	Drug: Placebo solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum measured concentration of the analyte in plasma (Cmax)	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
Area under the concentration-time curve of the analyte in plasma (AUC)	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
Total clearance of the analyte in plasma (CLtot/f)	up to 96 hours after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 2000
• Primary Completion (Actual): September 1, 2000

Study Registration Dates

• First Submitted: August 26, 2014
• First Submitted That Met QC Criteria: August 26, 2014
• First Posted (Estimate): August 27, 2014

Study Record Updates

• Last Update Posted (Estimate): August 27, 2014
• Last Update Submitted That Met QC Criteria: August 26, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: 1180.1