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

Healthy Volunteers Clinical Trial

Official title:

ASP8062 Phase 1 Study - A Placebo-controlled, Single and Multiple Ascending Oral Dose Study in Non-elderly Healthy Japanese Male and Female Subjects -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03183739
• Other study ID #: 8062-CL-0004
• Status: Completed
• Phase: Phase 1
• Start date: June 20, 2017
• Est. completion date: October 6, 2017

Study information

• Verified date: October 2018
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 6, 2017
• Est. primary completion date: October 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ASP8062
ASP8062 will be administered orally.
• Placebo
Placebo will be administered orally.

Locations

Country	Name	City	State
Japan	Site JP00001	Sumida	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessed by incidence of adverse events	Adverse events (AEs) will be coded using Medical Dictionary for Regulatory Activities (MedDRA).	Up to Day 38
Primary	Safety assessed by vital signs: supine blood pressure	To assess the vital sign as a criteria of safety and tolerability variables.	Up to Day 38
Primary	Safety assessed by vital signs: supine pulse rate	To assess the vital sign as a criteria of safety and tolerability variables.	Up to Day 38
Primary	Safety assessed by vital signs: axillary body temperature	To assess the vital sign as a criteria of safety and tolerability variables.	Up to Day 38
Primary	Orthostatic challenge tests	To assess the orthostatic challenge tests as a criteria of safety and tolerability variables.	Up to Day 20
Primary	Safety assessed by laboratory tests: Hematology	To assess hematology as a criteria of safety and tolerability variables.	Up to Day 38
Primary	Safety assessed by laboratory tests: Biochemistry	To assess biochemistry as a criteria of safety and tolerability variables.	Up to Day 38
Primary	Safety assessed by laboratory tests: Urinalysis	To assess urinalysis as a criteria of safety and tolerability variables.	Up to Day 38
Primary	Safety assessed by 12-lead electrocardiogram	To assess the cardiovascular system functioning as a criteria of safety and tolerability variables.	Up to Day 21
Primary	Columbia-Suicide Severity Rating Scale	To assess the suicide risk	Up to Day 20
Primary	Safety assessed by body weight	To assess the body weight as a criteria of safety and tolerability variables.	Up to Day 38
Secondary	Pharmacokinetics (PK) parameter for ASP8062: Maximum observed concentration (Cmax)	To assess the PK of ASP8062 in single dose part and multiple dose part.	Up to Day 38
Secondary	PK parameter for ASP8062: Time to maximum concentration (Tmax)	To assess the PK of ASP8062 in single dose part and multiple dose part.	Up to Day 38
Secondary	PK parameter for ASP8062: Terminal elimination half-life (t1/2)	To assess the PK of ASP8062 in single dose part and multiple dose part.	Up to Day 38
Secondary	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.	Up to Day 38
Secondary	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.	Up to Day 6
Secondary	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.	Up to Day 6
Secondary	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.	Up to Day 6
Secondary	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.	Up to Day 6
Secondary	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.	Up to Day 6
Secondary	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.	From Day 7 to Day 38
Secondary	PK parameter for ASP8062: Concentration immediately prior to dosing at multiple dosing (Ctrough)	To assess the PK of ASP8062 in multiple dose part.	From Day 7 to Day 20
Secondary	PK parameter for ASP8062: Percentage of AUCinf that is estimated by extrapolation (AUCinf (%extrap))	To assess the PK of ASP8062 in single dose part	Up to Day 6
Secondary	PK parameter for ASP8062: Terminal elimination rate constant (Lambda z)	To assess the PK of ASP8062 in single dose part and multiple dose part.	Up to Day 38
Secondary	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.	Up to Day 38
Secondary	Accumulation Ratio (Rac) of Cmax	To assess the PK of ASP8062 in multiple dose part.	From Day 7 to Day 38
Secondary	Rac of AUC	To assess the PK of ASP8062 in multiple dose part.	From Day 7 to Day 38
Secondary	Peak-Trough Ratio for last dosing in multiple dose part	To assess the PK of ASP8062 in multiple dose part.	Day 20 and Day 21