Study to Evaluate the Safety and Tolerability of ASP8062 in Healthy Japanese Male and Female Subjects
- Registration Number
- NCT03183739
- Lead Sponsor
- Astellas Pharma Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ASP8062 lower dose ASP8062 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. Placebo Placebo 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. ASP8062 higher dose ASP8062 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. ASP8062 middle dose ASP8062 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.
- Primary Outcome Measures
Name Time Method 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 12-lead electrocardiogram Up to Day 21 To assess the cardiovascular system functioning as a criteria of safety and tolerability variables.
Safety assessed by body weight Up to Day 38 To assess the body weight 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.
Safety assessed by laboratory tests: Urinalysis Up to Day 38 To assess urinalysis 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.
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: Biochemistry Up to Day 38 To assess biochemistry 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 laboratory tests: Hematology Up to Day 38 To assess hematology as a criteria of safety and tolerability variables.
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.
- Secondary Outcome Measures
Name Time Method Accumulation Ratio (Rac) of Cmax From Day 7 to Day 38 To assess the PK of ASP8062 in multiple dose part.
Rac of AUC From Day 7 to Day 38 To assess the PK of ASP8062 in multiple 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: 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: 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.
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.
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: 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: 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: 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: 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: 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.
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: 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: 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.
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.
Trial Locations
- Locations (1)
Site JP00001
🇯🇵Sumida, Tokyo, Japan