Multiple Oral Administration of ASP7991 to Non-elderly Male Subjects
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after multiple oral administrations to non-elderly subjects.
Condition or disease
HealthyPharmacokinetics of ASP7991
Drug: ASP7991Drug: Placebo
In each step (lowest dose, middle dose, highest dose), subjects are randomly assigned in a double blinded manner to receive either ASP7991 (n=9) or Placebo (n=3) and are administered repeatedly. Once daily, the subjects are administered ASP7991 or placebo orally 30 minutes after breakfast with 150 mL water for 7 days. After the each step the sponsor evaluates the safety in the blinded manner for deciding an escalation to the step.
The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs, ECGs for QT evaluation and slit lamp examination [ Time Frame: For 96 hours after dosing ]
Secondary Outcome Measures :
Plasma concentrations unchanged drug; AUC24h, Cmax, Ctrough, tmax, t1/2, CL/F, Vz/F [ Time Frame: For 96 hours after dosing ]
Urinary concentrations unchanged drug; Aelast, Aelast%, CLR [ Time Frame: For 96 hours after dosing ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
20 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy, as judged by the investigator/sub investigator based on the results of physical examination obtained before study drug administration