A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453 in Healthy Male Volunteers
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
57
0 countries
N/A
Study Start
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2008
Actual (reported)Study Completion
July 2008
Actual (reported)The purpose of this study is to assess the tolerability of BIA 5-453 after six multiple rising dose regimens of BIA 5-453.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
July 2008
Actual (reported)July 2008
Actual (reported)July 19, 2016
Actual (reported)July 21, 2016
Actual (reported)Percent of subjects with at least one adverse event
through study completion, an average of 10 days
Percent of subjects by dose group with at least one treatment-emergent adverse event (TEAEs)
Treatment-emergent adverse events are adverse events that occurred either in the 72 hours after dosing or that was present prior to dosing but exacerbated within 72 hours after dosing.
through study completion, an average of 10 days
Multiple oral doses of BIA 5-453 25 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
Multiple oral doses of BIA 5-453 50 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
Presented as blue hard gelatine capsules (size 2) of 1 mg, 10 mg and 50 mg for oral administration
57 participants (actual enrollment reported by the registry).
First Submitted
July 19, 2016
First Posted
July 21, 2016
Study Start
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
Absorption, Distribution, Metabolism and Excretion of [14C]- Labeled BIA 5-453 and Metabolites
Multiple oral doses of BIA 5-453 100 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
Multiple oral doses of BIA 5-453 200 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
Multiple oral doses of BIA 5-453 400 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
Multiple oral doses of BIA 5-453 600 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
July 2008
Actual (reported)Study Completion
July 2008
Actual (reported)Last Updated
July 21, 2016
Record last verified: 2016-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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