Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the safety, tolerability and pharmacokinetic of single/multiple ascending oral doses of ASP8302 in non-elderly healthy Japanese male and female subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose of ASP8302 dose-1 | Experimental | Subjects will receive a single dose of ASP8302. |
|
| Single dose of ASP8302 dose-2 | Experimental | Subjects will receive a single dose of ASP8302. |
|
| Single dose of ASP8302 dose-3 | Experimental | Subjects will receive a single dose of ASP8302. |
|
| Single dose of ASP8302 dose-4 | Experimental | Subjects will receive a single dose of ASP8302. |
|
| Single dose of Placebo | Placebo Comparator | Subjects will receive a single dose of Placebo. |
|
| Multiple dose of ASP8302 dose-5 | Experimental | Subjects will receive once daily dosing of ASP8302 for 14 consecutive days at the same dose level. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP8302 | Drug | ASP8302 will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by incidence of adverse events (AEs) | Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA). | Up to Day 6 in single ascending dose (SAD) part Up to Day 19 in MAD part |
| Safety assessed by vital signs: Body temperature | To assess vital signs as a criteria of safety variables. | Up to Day 6 in SAD part Up to Day 19 in multiple ascending dose (MAD) part |
| Safety assessed by vital signs: Blood pressure | To assess vital signs as a criteria of safety variables. | Up to Day 6 in SAD part Up to Day 19 in MAD part |
| Safety assessed by vital signs: Pulse rate | To assess vital signs as a criteria of safety variables. | Up to Day 6 in SAD part Up to Day 19 in MAD part |
| Number of participants with laboratory value abnormalities and/or AEs | Number of participants with potentially clinically significant laboratory values. | Up to Day 6 in SAD part Up to Day 19 in MAD part |
| Safety assessed by cardiac troponin | To assess the cardiovascular system function as a criteria of safety variables. | Up to Day 6 in SAD part Up to Day 19 in MAD part |
| Safety assessed by standard 12-lead electrocardiogram | To assess the cardiovascular system function as a criteria of safety variables. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) parameter for ASP8302: Maximum observed concentration (Cmax) in plasma | To assess the PK of ASP8302 in SAD part and MAD part. | Up to 72 hr after dosing in SAD part Day 1 and Day 14 in MAD part |
| PK parameter for ASP8302: Time of the Maximum Concentration (tmax) in plasma |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site JP00001 | Toshima 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/.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Multiple dose of ASP8302 dose-6 | Experimental | Subjects will receive once daily dosing of ASP8302 for 14 consecutive days at the same dose level. |
|
| Multiple dose of Placebo | Placebo Comparator | Subjects will receive once daily dosing of Placebo for 14 consecutive days. |
|
| Placebo | Drug | Placebo will be administered orally. |
|
| Up to Day 6 in SAD part Up to Day 19 in MAD part |
To assess the PK of ASP8302 in SAD part and MAD part. |
| Up to 72 hr after dosing in SAD part Day 1 and Day 14 in MAD part |
| PK parameter for ASP8302: Area under the concentration-time curve (AUC) from the time of dosing to 24h after dosing (AUC24) in plasma | To assess the PK of ASP8302 in SAD part and MAD part. | Up to 72 hr after dosing in SAD part Day 1 in MAD part |
| PK parameter for ASP8302: AUC from the Time of Dosing Extrapolated to Time Infinity (AUCinf) in plasma | To assess the PK of ASP8302 in SAD part. | Up to 72 hr after dosing in SAD part |
| PK parameter for ASP8302: AUC from the Time of Dosing to the Start of the Next Dosing Interval (AUCtau) in plasma | To assess the PK of ASP8302 in MAD part. | Day 14 in MAD part |
| PK parameter for ASP8302: Peak-Trough Ratio (PTR) in plasma | To assess the PK of ASP8302 in MAD part. | Day 14 in MAD part |
| PK parameter for ASP8302: Accumulation Ratio for AUC (Rac(AUC)) in plasma | To assess the PK of ASP8302 in MAD part. | Day 14 in MAD part |
| PK parameter for ASP8302: Accumulation Ratio for Cmax (Rac(Cmax)) in plasma | To assess the PK of ASP8302 in MAD part. | Day 14 in MAD part |
| PK parameter for ASP8302: AUC from the Time of Dosing to the Last Measurable Concentration (AUClast) in plasma | To assess the PK of ASP8302 in SAD part. | Up to 72 hr after dosing in SAD part |
| PK parameter for ASP8302: Time Point Prior to the Time Point Corresponding to the First Measurable (Non-zero) Concentration (tlag) in plasma | To assess the PK of ASP8302 in SAD part and MAD part. | Up to 72 hr after dosing in SAD part Day 1 in MAD part |
| PK parameter for ASP8302: Terminal Elimination Half-life (t1/2) in plasma | To assess the PK of ASP8302 in SAD part and MAD part. | Up to 72 hr after dosing in SAD part Day 14 in MAD part |
| PK parameter for ASP8302: Apparent Volume of Distribution during the Terminal Elimination Phase After Single Extra-Vascular Dosing (Vz/F) in plasma | To assess the PK of ASP8302 in SAD part. | Up to 72 hr after dosing in SAD part |
| PK parameter for ASP8302: Apparent Total Systemic Clearance After Single or Multiple Extra-Vascular Dosing (CL/F) in plasma | To assess the PK of ASP8302 in SAD part and MAD part. | Up to 72 hr after dosing in SAD part Day 14 in MAD part |
| PK parameter for ASP8302: Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) in plasma | To assess the PK of ASP8302 in MAD part. | Up to Day 14 in MAD part |
| PK parameter for ASP8302: Amount excreted into urine from the time of dosing to the 72 hours after dosing (Ae72) in urine | To assess the PK of ASP8302 in SAD part. | Up to 72 hr after dosing in SAD part |
| PK parameter for ASP8302: Fraction excreted into urine from the time of dosing to the 72 hours after dosing (Ae72%) in urine | To assess the PK of ASP8302 in SAD part. | Up to 72 hr after dosing in SAD part |
| PK parameter for ASP8302: Renal clearance (CLR) in urine | To assess the PK of ASP8302 in SAD part and MAD part. | Up to 72 hr after dosing in SAD part Day 14 in MAD part |
| PK parameter for ASP8302: Amount excreted into urine over the time interval between consecutive dosing (Aetau) in urine | To assess the PK of ASP8302 in MAD part. | Day 14 in MAD part |
| PK parameter for ASP8302: Fraction excreted into urine over the time interval between consecutive dosing (Aetau%) in urine | To assess the PK of ASP8302 in MAD part. | Day 14 in MAD part |
| Pharmacodynamic (PD) parameter for ASP8302: Pupil diameter | To assess the PD of ASP8302 in SAD part and MAD part. | Up to 24 hr after dosing in SAD part Up to Day 14 in MAD part |
| PD parameter for ASP8302: Salivary secretion | To assess the PD of ASP8302 in SAD part and MAD part. | Up to 24 hr after dosing in SAD part Up to Day 14 in MAD part |