Safety, Pharmacodynamics, and Pharmacokinetics After Multiple Different Oral Doses of BIIB 722 CL Tablets in Healthy Volunteers

NCT02268604 | Terminated Phase 1

• 1 other identifier: 1180.2
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to assess safety, pharmacodynamics and pharmacokinetics of BIIB 722 CL

Conditions

Healthy

Outcome Measures

Primary Outcomes (11)

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

  up to day 7

• Maximum measured concentration of the analyte in plasma (Cmax)

  up to day 7

• Time to maximum measured concentration of the analyte in plasma (tmax)

  up to day 7

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

  up to day 7

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

  up to day 7

• Terminal half-life of the analyte in plasma (t1/2)

  up to day 7

• Amount of the analyte excreted in urine (Ae)

  up to day 7

• Dose proportionality

  assessed by AUC

  up to day 7

• Accumulation factor

  (predose concentration/concentration after 8 hours)

  up to day 7

• Time to reach steady state

  up to day 7

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

  in vitro fluorescence

  up to day 7

Secondary Outcomes (3)

• Number of subjects with adverse events

  up to day 12

• Number of subjects with clinically significant findings in vital functions

  up to day 12

• Number of subjects with clinically significant findings in laboratory tests

  up to day 12

Study Arms (2)

BIIB 722 CL

EXPERIMENTAL

Drug: BIIB 722 CL

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIIB 722 CL DRUG

BIIB 722 CL

Placebo DRUG

Placebo

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 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 of during trial
• Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
• Alcohol abuse (\> 60 g/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

Study Design

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

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: October 20, 2014
• Study Start: October 1, 2010
• Primary Completion: October 1, 2010
• Last Updated: October 20, 2014

Record last verified: 2014-10