Healthy Volunteers
Conditions
Keywords
ASP8062, Pharmacokinetics, Safety
Brief summary
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.
Interventions
DRUGASP8062
ASP8062 will be administered orally.
DRUGPlacebo
Placebo will be administered orally.
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
* Body weight at screening: ≥ 50.0 kg and \< 80.0 kg for male, ≥ 40.0 kg and \< 70.0 kg for female. * Body Mass Index (BMI) at screening: ≥ 17.6 kg/m\^2 and \< 26.4 kg/m\^2 \[BMI = Body weight (kg) ÷ {Body height (m)\^2}\]. * Female subjects must agree to consistently use 2 forms of highly effective birth control starting at screening and throughout the study period and for 28 days after the final study drug administration. * Female subjects must not donate ova starting at informed consent and throughout the clinical study period, and for 28 days after the final study drug administration. * Male subjects and female spouse/partners who are of childbearing potential must be using condom and one of the highly effective birth control starting informed consent throughout the clinical study period and for 90 days after final study drug, if vasectomy is not performed for male subjects. * Male subjects must not donate sperm starting at informed consent and throughout the clinical study period, and for 90 days after study drug administration.
Exclusion criteria
* Subjects who participated or are scheduled to participate in any clinical trials or post-marketing studies within 120 days before screening test or during the screening test to the hospital admission (Day -2). * Subjects who received or is scheduled to receive any medications (including over-the-counter drugs) within seven days before the hospital admission. * Any deviation from the normal range of blood pressure, pulse, body temperature, or routine 12-lead ECG at screening or on the day of hospital admission (Day -1). * Subjects who meet any of the criterion for laboratory tests at screening or on the day of hospital admission (Day -2). * Any deviation from the normal range of routine 12-lead ECG at screening. * Subjects with a complication or history of drug allergies. * Subjects who developed upper gastrointestinal symptoms (nausea, vomiting, stomachache, etc.) within seven days before the hospital admission. * Subjects with a history of gastrointestinal resection except for appendicitis. * Subjects with a complication or history of hepatic disease, cardiac disease, respiratory disease, gastrointestinal disease, renal disease, endocrine disease, cerebrovascular disease or malignant tumor. * Subjects who received ASP8062 previously. * Subject has a relevant history of suicide attempt or suicidal behavior.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessed by incidence of adverse events | Up to Day 38 | Adverse events (AEs) will be coded using Medical Dictionary for Regulatory Activities (MedDRA). |
| Safety assessed by vital signs: supine blood pressure | Up to Day 38 | To assess the vital sign as a criteria of safety and tolerability variables. |
| Safety assessed by vital signs: supine pulse rate | Up to Day 38 | To assess the vital sign as a criteria of safety and tolerability variables. |
| Safety assessed by vital signs: axillary body temperature | Up to Day 38 | To assess the vital sign as a criteria of safety and tolerability variables. |
| Orthostatic challenge tests | Up to Day 20 | To assess the orthostatic challenge tests as a criteria of safety and tolerability variables. |
| Safety assessed by laboratory tests: Hematology | Up to Day 38 | To assess hematology as a criteria of safety and tolerability variables. |
| Safety assessed by laboratory tests: Biochemistry | Up to Day 38 | To assess biochemistry as a criteria of safety and tolerability variables. |
| Safety assessed by laboratory tests: Urinalysis | Up to Day 38 | To assess urinalysis as a criteria of safety and tolerability variables. |
| Safety assessed by 12-lead electrocardiogram | Up to Day 21 | To assess the cardiovascular system functioning as a criteria of safety and tolerability variables. |
| Columbia-Suicide Severity Rating Scale | Up to Day 20 | To assess the suicide risk |
| Safety assessed by body weight | Up to Day 38 | To assess the body weight as a criteria of safety and tolerability variables. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK parameter for ASP8062: Percentage of AUCinf that is estimated by extrapolation (AUCinf (%extrap)) | Up to Day 6 | To assess the PK of ASP8062 in single dose part |
| PK parameter for ASP8062: Terminal elimination rate constant (Lambda z) | Up to Day 38 | To assess the PK of ASP8062 in single dose part and multiple dose part. |
| PK parameter for ASP8062: Time of the last measurable concentration (tlast) | Up to Day 38 | To assess the PK of ASP8062 in single dose part and multiple dose part. |
| Pharmacokinetics (PK) parameter for ASP8062: Maximum observed concentration (Cmax) | Up to Day 38 | To assess the PK of ASP8062 in single dose part and multiple dose part. |
| Rac of AUC | From Day 7 to Day 38 | To assess the PK of ASP8062 in multiple dose part. |
| Peak-Trough Ratio for last dosing in multiple dose part | Day 20 and Day 21 | To assess the PK of ASP8062 in multiple dose part. |
| Accumulation Ratio (Rac) of Cmax | From Day 7 to Day 38 | To assess the PK of ASP8062 in multiple dose part. |
| PK parameter for ASP8062: Time to maximum concentration (Tmax) | Up to Day 38 | To assess the PK of ASP8062 in single dose part and multiple dose part. |
| PK parameter for ASP8062: Terminal elimination half-life (t1/2) | Up to Day 38 | To assess the PK of ASP8062 in single dose part and multiple dose part. |
| PK parameter for ASP8062: Apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F) | Up to Day 38 | To assess the PK of ASP8062 in single dose part and multiple dose part. |
| PK parameter for ASP8062: Area under the concentration-time curve (AUC) from the time of dosing to 24 h after dosing (AUC24) | Up to Day 6 | To assess the PK of ASP8062 in single dose part. |
| PK parameter for ASP8062: AUC from the time of dosing extrapolated to time infinity (AUCinf) | Up to Day 6 | To assess the PK of ASP8062 in single dose part. |
| PK parameter for ASP8062: AUC from the time of dosing to the last measurable concentration (AUClast) | Up to Day 6 | To assess the PK of ASP8062 in single dose part. |
| PK parameter for ASP8062: Time point prior to the time point corresponding to the first measurable (non-zero) concentration (tlag) | Up to Day 6 | To assess the PK of ASP8062 in single dose part. |
| PK parameter for ASP8062: Apparent volume of distribution during the terminal elimination phase after single extra-vascular dosing (Vz/F) | Up to Day 6 | To assess the PK of ASP8062 in single dose part. |
| PK parameter for ASP8062: AUC from the time of dosing to the start of the next dosing interval (AUCtau) | From Day 7 to Day 38 | To assess the PK of ASP8062 in multiple dose part. |
| PK parameter for ASP8062: Concentration immediately prior to dosing at multiple dosing (Ctrough) | From Day 7 to Day 20 | To assess the PK of ASP8062 in multiple dose part. |
Countries
Japan
Outcome results
None listed