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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo tablet; Drug: Placebo solution; Drug: BIIB 722 CL solution; Drug: BIIB 722 CL tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02227030

1180.1

Details and patient eligibility

About

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

Enrollment: 71 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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71 participants in 4 patient groups, including a placebo group

BIIB 722 CL single rising dose

Experimental group

Treatment:

Drug: BIIB 722 CL solution

BIIB 722 CL cross over

Experimental group

Treatment:

Drug: BIIB 722 CL solution

Drug: BIIB 722 CL tablet

Placebo solution

Placebo Comparator group

Treatment:

Drug: Placebo solution

Placebo tablet

Placebo Comparator group

Treatment:

Drug: Placebo tablet