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

Healthy Clinical Trial

Official title:

Safety, Pharmacodynamics, and Pharmacokinetics After Multiple Oral Doses of 200 and 300 mg BIIB 722 CL Tablet Tid and 300 and 450 mg BIIB 722 CL Tablet Bid Over 7 Days to Healthy Volunteer Subjects. An Open Study, Placebo-controlled Randomised Double Blind at Each Dose Level.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02268604
• Other study ID #: 1180.2
• Status: Terminated
• Phase: Phase 1
• First received: August 21, 2014
• Last updated: October 16, 2014
• Start date: October 2010

Study information

• Verified date: October 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BIIB 722 CL

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration-time curve of the analyte in plasma (AUC)		up to day 7	No
Primary	Maximum measured concentration of the analyte in plasma (Cmax)		up to day 7	No
Primary	Time to maximum measured concentration of the analyte in plasma (tmax)		up to day 7	No
Primary	Total mean residence time of the analyte in the body (MRTtot)		up to day 7	No
Primary	Total clearance of the analyte in plasma (CLtot/f)		up to day 7	No
Primary	Terminal half-life of the analyte in plasma (t1/2)		up to day 7	No
Primary	Amount of the analyte excreted in urine (Ae)		up to day 7	No
Primary	Dose proportionality	assessed by AUC	up to day 7	No
Primary	Accumulation factor	(predose concentration/concentration after 8 hours)	up to day 7	No
Primary	Time to reach steady state		up to day 7	No
Primary	Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery	in vitro fluorescence	up to day 7	No
Secondary	Number of subjects with adverse events		up to day 12	No
Secondary	Number of subjects with clinically significant findings in vital functions		up to day 12	No
Secondary	Number of subjects with clinically significant findings in laboratory tests		up to day 12	No

External Links

•   Link