A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults
A Phase 1 Crossover Design Study to Assess the Effect of CYP3A Moderate and Strong Inhibitors (Fluconazole and Itraconazole) and Strong Inducer (Carbamazepine) on the Single-dose Pharmacokinetics of ASP3082 in Healthy Adults
Sponsor: Astellas Pharma Global Development, Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Pharmacokinetics (PK) of ASP3082 in plasma: Maximum Concentration (Cmax) in ASP3082
Time frame: Up to 29 days
PK of ASP3082 in plasma: area under the concentration-time curve from time zero to the time of the last measurable concentration (AUClast) in ASP3082
Time frame: Up to 29 days
PK of ASP3082 in plasma: area under the concentration-time curve extrapolated to infinity (AUCinf) in ASP3082
Time frame: Up to 29 days
PK of ASP3082 in plasma: Cmax in ASP3082+ Fluconazole (FLZ)
Time frame: Up to 29 days
Secondary Endpoints
Number of Participants with Adverse Events (AEs)
Number of Participants with laboratory value abnormalities and/or AEs
Number of Participants with vital sign abnormalities and/or AEs
Eligibility Criteria
Inclusion Criteria: * Participant is healthy and has no clinically significant medical condition based on the physical examination, electrocardiograms (ECGs) and protocol-defined clinical laboratory tests at screening or on day -1. * Female participant is not pregnant and is not a woman of childbearing potential (WOCBP) * Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives (approximately 28 days after final study intervention administration). * Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period and for 3 months after final study intervention administration. * Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 3 months after final study intervention administration. * Male participant must agree…
Read full criteria on CT.gov →✦ Analyst Commentary
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