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Trial record 19 of 23 for:    betadex

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

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ClinicalTrials.gov Identifier: NCT02224079
Recruitment Status : Completed
First Posted : August 25, 2014
Last Update Posted : August 25, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE August 21, 2014
First Posted Date  ICMJE August 25, 2014
Last Update Posted Date August 25, 2014
Study Start Date  ICMJE April 2002
Actual Primary Completion Date June 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2014)
  • Number of subjects with adverse events [ Time Frame: up to 12 days after drug administration ]
  • Number of subjects with clinically significant findings in vital signs [ Time Frame: up to 12 days after drug administration ]
    blood pressure, pulse rate, respiratory rate, oral body temperature
  • Number of subjects with clinically significant findings in ECG [ Time Frame: up to 12 days after drug administration ]
  • Number of subjects with clinically significant findings in laboratory tests [ Time Frame: up to 12 days after drug administration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2014)
  • Plasma concentration time profiles [ Time Frame: up to 96 hours after drug administration ]
  • Maximum measured concentration of the analyte in plasma (Cmax) [ Time Frame: up to 96 hours after drug administration ]
  • Time from dosing to the maximum concentration of the analyte in plasma (tmax) [ Time Frame: 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) [ Time Frame: up to 96 hours after drug administration ]
  • Terminal half-life of the analyte in plasma (t1/2) [ Time Frame: up to 96 hours after drug administration ]
  • Mean residence time of the analyte in the body (MRT) [ Time Frame: up to 96 hours after drug administration ]
  • Total clearance of the analyte in plasma (CL) [ Time Frame: up to 96 hours after drug administration ]
  • Apparent volume of distribution at steady state (Vss) [ Time Frame: up to 96 hours after drug administration ]
  • Amount of drug excreted into urine (Ae) [ Time Frame: up to 72 hours after drug administration ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BIIB 722 CL and HPβCD in Young Healthy Male Volunteers
Official Title  ICMJE 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.
Brief Summary Study to assess safety, tolerability and pharmacokinetics (PK) of single intravenous (i.v.) doses of BIIB 722 CL
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: BIIB 722 CL
  • Drug: Placebo
    Hydroxypropyl-beta-cyclodextrin (HPβCD)
Study Arms  ICMJE
  • Experimental: BIIB 722 CL
    Interventions:
    • Drug: BIIB 722 CL
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2014)
100
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02224079
Other Study ID Numbers  ICMJE 1180.3
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP