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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP8062 lower dose | Experimental | Subjects will receive a single dose of ASP8062 on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level. |
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| ASP8062 middle dose | Experimental | Subjects will receive a single dose of ASP8062 on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level. |
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| ASP8062 higher dose | Experimental | Subjects will receive a single dose of ASP8062 on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level. |
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| Placebo | Placebo Comparator | Subjects will receive a single dose of Placebo on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP8062 | Drug | ASP8062 will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by incidence of adverse events | Adverse events (AEs) will be coded using Medical Dictionary for Regulatory Activities (MedDRA). | Up to Day 38 |
| Safety assessed by vital signs: supine blood pressure | To assess the vital sign as a criteria of safety and tolerability variables. | Up to Day 38 |
| Safety assessed by vital signs: supine pulse rate | To assess the vital sign as a criteria of safety and tolerability variables. | Up to Day 38 |
| Safety assessed by vital signs: axillary body temperature | To assess the vital sign as a criteria of safety and tolerability variables. | Up to Day 38 |
| Orthostatic challenge tests | To assess the orthostatic challenge tests as a criteria of safety and tolerability variables. | Up to Day 20 |
| Safety assessed by laboratory tests: Hematology | To assess hematology as a criteria of safety and tolerability variables. | Up to Day 38 |
| Safety assessed by laboratory tests: Biochemistry | To assess biochemistry as a criteria of safety and tolerability variables. | Up to Day 38 |
| Safety assessed by laboratory tests: Urinalysis |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) parameter for ASP8062: Maximum observed concentration (Cmax) | To assess the PK of ASP8062 in single dose part and multiple dose part. | Up to Day 38 |
| PK parameter for ASP8062: Time to maximum concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site JP00001 | Sumida City | Tokyo | Japan |
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| ID | Term |
|---|---|
| C000709210 | ASP8062 |
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| Placebo | Drug | Placebo will be administered orally. |
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To assess urinalysis as a criteria of safety and tolerability variables. |
| Up to Day 38 |
| Safety assessed by 12-lead electrocardiogram | To assess the cardiovascular system functioning as a criteria of safety and tolerability variables. | Up to Day 21 |
| Columbia-Suicide Severity Rating Scale | To assess the suicide risk | Up to Day 20 |
| Safety assessed by body weight | To assess the body weight as a criteria of safety and tolerability variables. | Up to Day 38 |
To assess the PK of ASP8062 in single dose part and multiple dose part.
| Up to Day 38 |
| PK parameter for ASP8062: Terminal elimination half-life (t1/2) | To assess the PK of ASP8062 in single dose part and multiple dose part. | Up to Day 38 |
| PK parameter for ASP8062: Apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F) | To assess the PK of ASP8062 in single dose part and multiple dose part. | Up to Day 38 |
| PK parameter for ASP8062: Area under the concentration-time curve (AUC) from the time of dosing to 24 h after dosing (AUC24) | To assess the PK of ASP8062 in single dose part. | Up to Day 6 |
| PK parameter for ASP8062: AUC from the time of dosing extrapolated to time infinity (AUCinf) | To assess the PK of ASP8062 in single dose part. | Up to Day 6 |
| PK parameter for ASP8062: AUC from the time of dosing to the last measurable concentration (AUClast) | To assess the PK of ASP8062 in single dose part. | Up to Day 6 |
| PK parameter for ASP8062: Time point prior to the time point corresponding to the first measurable (non-zero) concentration (tlag) | To assess the PK of ASP8062 in single dose part. | Up to Day 6 |
| PK parameter for ASP8062: Apparent volume of distribution during the terminal elimination phase after single extra-vascular dosing (Vz/F) | To assess the PK of ASP8062 in single dose part. | Up to Day 6 |
| PK parameter for ASP8062: AUC from the time of dosing to the start of the next dosing interval (AUCtau) | To assess the PK of ASP8062 in multiple dose part. | From Day 7 to Day 38 |
| PK parameter for ASP8062: Concentration immediately prior to dosing at multiple dosing (Ctrough) | To assess the PK of ASP8062 in multiple dose part. | From Day 7 to Day 20 |
| PK parameter for ASP8062: Percentage of AUCinf that is estimated by extrapolation (AUCinf (%extrap)) | To assess the PK of ASP8062 in single dose part | Up to Day 6 |
| PK parameter for ASP8062: Terminal elimination rate constant (Lambda z) | To assess the PK of ASP8062 in single dose part and multiple dose part. | Up to Day 38 |
| PK parameter for ASP8062: Time of the last measurable concentration (tlast) | To assess the PK of ASP8062 in single dose part and multiple dose part. | Up to Day 38 |
| Accumulation Ratio (Rac) of Cmax | To assess the PK of ASP8062 in multiple dose part. | From Day 7 to Day 38 |
| Rac of AUC | To assess the PK of ASP8062 in multiple dose part. | From Day 7 to Day 38 |
| Peak-Trough Ratio for last dosing in multiple dose part | To assess the PK of ASP8062 in multiple dose part. | Day 20 and Day 21 |