Site JP00001
Sumida City, Tokyo, Japan
NCT Number: NCT03183739
The purpose of this study is to evaluate the safety and tolerability and evaluate pharmacokinetics of single and multiple ascending oral doses of ASP8062 in nonelderly Japanese male and female subjects.
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Notify Me20 year–44 year
All sexes
Interventional
Phase 1
Sumida City, Tokyo, Japan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ASP8062 will be administered orally.
Placebo will be administered orally.
Time frame: Up to Day 38
Adverse events (AEs) will be coded using Medical Dictionary for Regulatory Activities (MedDRA).
Time frame: Up to Day 38
To assess the vital sign as a criteria of safety and tolerability variables.
Time frame: Up to Day 38
To assess the vital sign as a criteria of safety and tolerability variables.
Time frame: Up to Day 38
To assess the vital sign as a criteria of safety and tolerability variables.
Time frame: Up to Day 20
To assess the orthostatic challenge tests as a criteria of safety and tolerability variables.
Time frame: Up to Day 38
To assess hematology as a criteria of safety and tolerability variables.
Time frame: Up to Day 38
To assess biochemistry as a criteria of safety and tolerability variables.
Time frame: Up to Day 38
To assess urinalysis as a criteria of safety and tolerability variables.
Time frame: Up to Day 21
To assess the cardiovascular system functioning as a criteria of safety and tolerability variables.
Time frame: Up to Day 20
To assess the suicide risk
Time frame: Up to Day 38
To assess the body weight as a criteria of safety and tolerability variables.
Time frame: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
Time frame: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
Time frame: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
Time frame: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
Time frame: Up to Day 6
To assess the PK of ASP8062 in single dose part.
Time frame: Up to Day 6
To assess the PK of ASP8062 in single dose part.
Time frame: Up to Day 6
To assess the PK of ASP8062 in single dose part.
Time frame: Up to Day 6
To assess the PK of ASP8062 in single dose part.
Time frame: Up to Day 6
To assess the PK of ASP8062 in single dose part.
Time frame: From Day 7 to Day 38
To assess the PK of ASP8062 in multiple dose part.
Time frame: From Day 7 to Day 20
To assess the PK of ASP8062 in multiple dose part.
Time frame: Up to Day 6
To assess the PK of ASP8062 in single dose part
Time frame: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
Time frame: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
Time frame: From Day 7 to Day 38
To assess the PK of ASP8062 in multiple dose part.
Time frame: From Day 7 to Day 38
To assess the PK of ASP8062 in multiple dose part.
Time frame: Day 20 and Day 21
To assess the PK of ASP8062 in multiple dose part.
Astellas Pharma Inc
Industry
ASP8062 Phase 1 Study - A Placebo-controlled, Single and Multiple Ascending Oral Dose Study in Non-elderly Healthy Japanese Male and Female Subjects -
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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