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

NCT ID: NCT02227030

Last Updated: 2014-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-04-30

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BIIB 722 CL single rising dose

Group Type: EXPERIMENTAL

BIIB 722 CL solution

Intervention Type: DRUG

BIIB 722 CL cross over

Group Type: EXPERIMENTAL

BIIB 722 CL solution

Intervention Type: DRUG

BIIB 722 CL tablet

Intervention Type: DRUG

Placebo solution

Group Type: PLACEBO_COMPARATOR

Placebo solution

Intervention Type: DRUG

Placebo tablet

Group Type: PLACEBO_COMPARATOR

Placebo tablet

Intervention Type: DRUG

Interventions

BIIB 722 CL solution

Intervention Type: DRUG

BIIB 722 CL tablet

Intervention Type: DRUG

Placebo solution

Intervention Type: DRUG

Placebo tablet

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1180.1

Identifier Type: -

Identifier Source: org_study_id