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The purpose of this study is to explore the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of ASP4058 in non-elderly, healthy male and female subjects. This study will also explore the effect of food on the PK of ASP4058.The food-effect crossover group was open-label treatment with no placebo control.
Subjects will remain in the clinic for 9 days. Subjects will return to the clinic for follow-up on days 12 and 30 to collect additional safety information.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP4058 Tablet Dose Escalation Cohort | Experimental |
| |
| ASP4058 Tablet - Fasting conditions | Experimental |
| |
| ASP4058 Tablet - Fed conditions | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP4058 | Drug | Oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter of ASP4058: Cmax | Maximum Concentration (Cmax) | Day 1-8 |
| Pharmacokinetic parameter of ASP4058: AUCinf | Area Under the Concentration - Time curve from time 0 extrapolated to infinity (AUCinf) | Day 1-8 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of pharmacokinetic parameters of ASP4058 in plasma: AUClast, Tmax, t1/2, tlag, Vz/F, CL/F | Area Under the Concentration - Time curve from time 0 up to the last quantifiable concentration (AUClast), Time to Attain Cmax (Tmax), Apparent Terminal Elimination Half-life (t1/2), Time prior to the first measurable (non-zero) concentration (tlag), Apparent Volume of Distribution During the Terminal Phase of the Plasma Concentration vs. Time Profile (Vz/F), Apparent Total Body Plasma Clearance (CL/F) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Global Development, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami, Inc | Miami | Florida | 33014 | United States | ||
| Covance Clinical Research Unit, Inc. |
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| Placebo | Drug | Oral tablet |
|
| Day 1-8 |
| Composite of pharmacokinetic parameter of ASP4058 in urine: Aelast, Aelast%, CLr | Cumulative urine drug excretion from time 0 up to the last measurable concentration (Aelast), Fraction of drug into urine up to the collection time of the last measurable concentration (Aelast%), Renal Clearance (CLr) | Day 1-8 |
| Pharmacodynamics of ASP4058: white blood cell determination with differentials, lymphocyte subsets | Day 1-8 |
| Evansville |
| Indiana |
| 47710 |
| United States |
| ID | Term |
|---|---|
| C000598902 | ASP4058 |
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