InVentiv Health
Miami, Florida, 33136, United States
NCT Number: NCT02853643
The purpose of this study is to evaluate the safety and tolerability, and determine the blood levels (pharmacokinetics), in both a fed and fasted condition, of a single dose of ASN002. Healthy volunteers will be participants in the study.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Miami, Florida, 33136, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects to whom any of the following applies will be excluded from the study:
Single dose study with food effect
Time frame: Days 1-28
Safety and tolerability will be determined by the number of subjects reporting adverse events during the study.
Time frame: Days 1-6
Calculate Area under the plasma concentration time curve (AUC) from time 0 to infinity after first dose. AUC from time 0 to the time of last measured concentration. AUC from time 0 to 24 hours.
Time frame: Days 1-6
Calculate Area under the plasma concentration time curve (AUC) from time 0 to infinity after first dose. AUC from time 0 to the time of last measured concentration. AUC from time 0 to 24 hours.
Time frame: Days 1-6
Calculate observed maximum plasma concentration after a dose and observed maximum plasma concentration at steady state. The time to reach the peak plasma concentration. The time to reach the peak plasma concentration at steady state.
Time frame: Days 1-6
Calculate observed maximum plasma concentration after a dose and observed maximum plasma concentration at steady state. The time to reach the peak plasma concentration. The time to reach the peak plasma concentration at steady state.
Time frame: Days 1-6
Calculate terminal elimination rate constant and terminal half-life of ASN002
Time frame: Days 1-6
Calculate terminal elimination rate constant and terminal half-life of ASN002
Asana BioSciences
Industry
A Phase 1, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food-Effect in Healthy Volunteers
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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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