NCT Number: NCT02227030
Tolerability and Pharmacokinetics of BIIB 722 CL Drinking Solution and of BIIB 722 CL Filmcoated Tablet in Healthy Subjects
Safety and pharmacokinetics after oral single rising doses of BIIB 722 CL
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Conditions
Age range
18 year–55 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
BIIB 722 CL tablet
DrugPlacebo solution
DrugPlacebo Tablet
DrugPrimary outcomes
-
Area under the concentration-time curve of the analyte in plasma (AUC)
Time frame: up to 96 hours after drug administration
-
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: up to 96 hours after drug administration
-
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time frame: up to 96 hours after drug administration
-
Total mean residence time of the analyte in the body (MRTtot)
Time frame: up to 96 hours after drug administration
-
Total clearance of the analyte in plasma (CLtot/f)
Time frame: up to 96 hours after drug administration
Secondary outcomes
-
Number of subjects with adverse events
Time frame: up to 96 hours after drug administration
-
Number of subjects with clinically significant findings in vital functions
Time frame: up to 96 hours after drug administration
-
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 96 hours after drug administration
-
Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery
Time frame: up to 24 hours after drug administration
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study title
Tolerability and Pharmacokinetics of Single Oral Administration of 10, 20, 50, 100, 200 and 300 mg BIIB 722 CL (Calculated as Free Base) as Drinking Solution and of 200, 450, 600 and 750 mg BIIB 722 CL as Filmcoated Tablet in Healthy Subjects. An Open Study With Rising Doses, Partly Uncontrolled Intra-individual Comparison, Placebo Randomised Double Blind at Each Dose Level.
Important dates
- Study start
- 2000
- Primary completion
- 2000
- First posted
- Aug 27, 2014
- Registry last updated
- Aug 27, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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