Study to Evaluate the Safety and Tolerability of ASP8062 in Healthy Japanese Male and Female Subjects

Astellas Pharma Inc36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

ASP8062DRUG

ASP8062 will be administered orally.

PlaceboDRUG

Placebo will be administered orally.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 44 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Site JP00001

Sumida City, Tokyo, Japan

Outcomes

Primary Outcomes

Safety assessed by incidence of adverse events

Adverse events (AEs) will be coded using Medical Dictionary for Regulatory Activities (MedDRA).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to Day 38

Orthostatic challenge tests

To assess the orthostatic challenge tests as a criteria of safety and tolerability variables.

Time frame: Up to Day 20

Safety assessed by laboratory tests: Hematology

To assess hematology as a criteria of safety and tolerability variables.

Time frame: Up to Day 38

Safety assessed by laboratory tests: Biochemistry

To assess biochemistry as a criteria of safety and tolerability variables.

Time frame: Up to Day 38

Safety assessed by laboratory tests: Urinalysis

To assess urinalysis as a criteria of safety and tolerability variables.

Time frame: Up to Day 38

Data from ClinicalTrials.gov

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Secondary Outcomes

Pharmacokinetics (PK) parameter for ASP8062: Maximum observed concentration (Cmax)

To assess the PK of ASP8062 in single dose part and multiple dose part.

Time frame: Up to Day 38

PK parameter for ASP8062: Time to maximum concentration (Tmax)

To assess the PK of ASP8062 in single dose part and multiple dose part.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: Up to Day 38

Accumulation Ratio (Rac) of Cmax

To assess the PK of ASP8062 in multiple dose part.

Time frame: From Day 7 to Day 38

Rac of AUC

To assess the PK of ASP8062 in multiple dose part.

Time frame: 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.

Time frame: Day 20 and Day 21