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

NCT02224079 | Completed Phase 1

• 1 other identifier: 1180.3
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• 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

Study Arms (2)

BIIB 722 CL

EXPERIMENTAL

Drug: BIIB 722 CL; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIIB 722 CL DRUG

BIIB 722 CL

Placebo DRUG

Hydroxypropyl-beta-cyclodextrin (HPβCD)

BIIB 722 CL; Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males
• to 50 years of age
• Broca index \>= -20% and \<= +20%
• Written informed consent according to Good Clinical Practice (GCP) and local legislation

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 25, 2014
• Study Start: April 1, 2002
• Primary Completion: June 1, 2002
• Last Updated: August 25, 2014

Record last verified: 2014-08