Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BIIB 722 CL and HPβCD in Young Healthy Male Volunteers

Safety, Tolerability and Preliminary Pharmacokinetics of Single Rising Doses of 1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg, 125 mg and 150 mg BIIB 722 CL (Calculated as 'Free Base') and HPβCD Given as Intravenous Infusion Over 30 Minutes to Young Healthy Male Subjects. A Single-centre, Single-blind, Placebo-controlled, Randomised Study.

Study to assess safety, tolerability and pharmacokinetics (PK) of single intravenous (i.v.) doses of BIIB 722 CL

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy males
• 21 to 50 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 or hormonal disorders
• Diseases of the central nervous system or psychiatric disorders or neurological disorders
• History of orthostatic hypotension, fainting spells or blackouts
• 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 at least one month or less than ten half-lives of the respective drug before enrolment in the study
• Use of any drugs, which might influence the results of the trial within two weeks prior to administration or during the trial
• Participation in another trial with an investigational drug (<= two months prior to administration or during trial)
• Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
• Inability to refrain from smoking on study days
• Alcohol abuse (> 60 g/day)
• Drug abuse
• Blood donation (>= 100 mL within four weeks prior to administration or during the trial)
• Excessive physical activities (within the last week before the study)
• Any laboratory value outside the reference range of clinical relevance

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Hydroxypropyl-beta-cyclodextrin (HPβCD)
Experimental: BIIB 722 CL	Drug: BIIB 722 CL; Drug: Placebo; Hydroxypropyl-beta-cyclodextrin (HPβCD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with adverse events		up to 12 days after drug administration
Number of subjects with clinically significant findings in vital signs	blood pressure, pulse rate, respiratory rate, oral body temperature	up to 12 days after drug administration
Number of subjects with clinically significant findings in ECG		up to 12 days after drug administration
Number of subjects with clinically significant findings in laboratory tests		up to 12 days after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma concentration time profiles	up to 96 hours after drug administration
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 from time zero to a specified point in time (AUC0-t)	up to 96 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)	up to 96 hours after drug administration
Mean residence time of the analyte in the body (MRT)	up to 96 hours after drug administration
Total clearance of the analyte in plasma (CL)	up to 96 hours after drug administration
Apparent volume of distribution at steady state (Vss)	up to 96 hours after drug administration
Amount of drug excreted into urine (Ae)	up to 72 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, 2002
• Primary Completion (Actual): June 1, 2002
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: August 21, 2014
• First Submitted That Met QC Criteria: August 21, 2014
• First Posted (Estimate): August 25, 2014

Study Record Updates

• Last Update Posted (Estimate): August 25, 2014
• Last Update Submitted That Met QC Criteria: August 21, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 1180.3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No