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

NCT02227030 | Completed Phase 1

• 1 other identifier: 1180.1
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Area under the concentration-time curve of the analyte in plasma (AUC)

  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

• Total mean residence time of the analyte in the body (MRTtot)

  up to 96 hours after drug administration

• Total clearance of the analyte in plasma (CLtot/f)

  up to 96 hours after drug administration

Secondary Outcomes (4)

• Number of subjects with adverse events

  up to 96 hours after drug administration

• Number of subjects with clinically significant findings in vital functions

  up to 96 hours after drug administration

• Number of subjects with clinically significant findings in laboratory tests

  up to 96 hours after drug administration

• Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery

  up to 24 hours after drug administration

Study Arms (4)

BIIB 722 CL single rising dose

EXPERIMENTAL

Drug: BIIB 722 CL solution

BIIB 722 CL cross over

EXPERIMENTAL

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

Placebo solution

PLACEBO COMPARATOR

Drug: Placebo solution

Placebo tablet

PLACEBO COMPARATOR

Drug: Placebo tablet

Interventions

BIIB 722 CL solution DRUG

BIIB 722 CL cross over; BIIB 722 CL single rising dose

BIIB 722 CL tablet DRUG

BIIB 722 CL cross over

Placebo solution DRUG

Placebo solution

Placebo tablet DRUG

Placebo tablet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males
• to 55 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, 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Solutions; Tablets

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Dosage Forms

Study Design

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

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 27, 2014
• Study Start: April 1, 2000
• Primary Completion: September 1, 2000
• Last Updated: August 27, 2014

Record last verified: 2014-08