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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

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

Condition or disease Intervention/treatment Phase
Healthy Drug: BIIB 722 CL Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: 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 Start Date : April 2002
Actual Primary Completion Date : June 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Chlorine

Arm Intervention/treatment
Experimental: BIIB 722 CL Drug: BIIB 722 CL
Drug: Placebo
Hydroxypropyl-beta-cyclodextrin (HPβCD)

Placebo Comparator: Placebo Drug: Placebo
Hydroxypropyl-beta-cyclodextrin (HPβCD)




Primary Outcome Measures :
  1. Number of subjects with adverse events [ Time Frame: up to 12 days after drug administration ]
  2. 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

  3. Number of subjects with clinically significant findings in ECG [ Time Frame: up to 12 days after drug administration ]
  4. Number of subjects with clinically significant findings in laboratory tests [ Time Frame: up to 12 days after drug administration ]

Secondary Outcome Measures :
  1. Plasma concentration time profiles [ Time Frame: up to 96 hours after drug administration ]
  2. Maximum measured concentration of the analyte in plasma (Cmax) [ Time Frame: up to 96 hours after drug administration ]
  3. Time from dosing to the maximum concentration of the analyte in plasma (tmax) [ Time Frame: up to 96 hours after drug administration ]
  4. 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 ]
  5. Terminal half-life of the analyte in plasma (t1/2) [ Time Frame: up to 96 hours after drug administration ]
  6. Mean residence time of the analyte in the body (MRT) [ Time Frame: up to 96 hours after drug administration ]
  7. Total clearance of the analyte in plasma (CL) [ Time Frame: up to 96 hours after drug administration ]
  8. Apparent volume of distribution at steady state (Vss) [ Time Frame: up to 96 hours after drug administration ]
  9. Amount of drug excreted into urine (Ae) [ Time Frame: up to 72 hours after drug administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02224079     History of Changes
Other Study ID Numbers: 1180.3
First Posted: August 25, 2014    Key Record Dates
Last Update Posted: August 25, 2014
Last Verified: August 2014