AC430 will be administered, orally under fasting conditions (fasting 4 hours before and 2 hours after dosing) with approximately 240 mL of water either once daily or twice daily. It is designed to assess the safety, tolerability, and pharmacokinetics of single and multiple oral doses of AC430.
A dose-finding study of AC430 in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
88
Healthy volunteers will either receive AC430 or placebo.
Covance Clinical Research Unit
Madison, Wisconsin, United States
Assess the safety, tolerability, and pharmacokinetics of single and multiple oral doses of AC430.
* Number of participants with adverse events as measurement of safety and tolerability of AC430. \[Time frame: 1-28 days\] * Maximum concentration (Cmax) for AC430 in plasma (measured in ng/mL) \[Time frame: 1-28 days\] * Tmax = Time of maximum concentration of AC430 in plasma (hr) \[Time frame: 1-28 days\] * AUC = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL) \[Time frame: 1-28 days\] * Urine: amount of AC430 excreted in urine (Ae0-48), renal clearance (CLr) and fraction of drug excreted in urine (Fe). \[Time frame: 1-28 days\]
Time frame: 6 months
Determine the pharmacodynamic effects of single and multiple oral doses of AC430.
* Single ascending dose (SAD): Pharmacodynamics (blood analysis) of AC430 \[Time Frame: up to 8 days post dose\] \[Designated as safety issue: No\] * Multiple ascending doses (MAD): Pharmacodynamics (blood analysis) of AC430 \[Time Frame: up to 17 days postdose\] \[Designated as safety issue: No\]
Time frame: Measured at specific timepoints prior to and following dosing regimen.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.