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

NCT03183739 | Completed Phase 1

• 1 other identifier: 8062-CL-0004
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

ASP8062; Pharmacokinetics; Safety

Outcome Measures

Primary Outcomes (11)

• Safety assessed by incidence of adverse events

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

  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.

  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.

  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.

  Up to Day 38

• Orthostatic challenge tests

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

  Up to Day 20

• Safety assessed by laboratory tests: Hematology

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

  Up to Day 38

• Safety assessed by laboratory tests: Biochemistry

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

  Up to Day 38

• Safety assessed by laboratory tests: Urinalysis

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

  Up to Day 38

• Safety assessed by 12-lead electrocardiogram

  To assess the cardiovascular system functioning as a criteria of safety and tolerability variables.

  Up to Day 21

• Columbia-Suicide Severity Rating Scale

  To assess the suicide risk

  Up to Day 20

• Safety assessed by body weight

  To assess the body weight as a criteria of safety and tolerability variables.

  Up to Day 38

Secondary Outcomes (17)

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

  Up to Day 38

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

  Up to Day 38

• PK parameter for ASP8062: Terminal elimination half-life (t1/2)

  Up to Day 38

• PK parameter for ASP8062: Apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F)

  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)

  Up to Day 6

Study Arms (4)

ASP8062 lower dose

EXPERIMENTAL

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.

Drug: ASP8062

ASP8062 middle dose

EXPERIMENTAL

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.

Drug: ASP8062

ASP8062 higher dose

EXPERIMENTAL

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.

Drug: ASP8062

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

ASP8062 DRUG

ASP8062 will be administered orally.

ASP8062 higher dose; ASP8062 lower dose; ASP8062 middle dose

Placebo DRUG

Placebo will be administered orally.

Placebo

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Site JP00001

Sumida City, Tokyo, Japan

Location

MeSH Terms

Interventions

ASP8062

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 12, 2017
• Study Start: June 20, 2017
• Primary Completion: October 6, 2017
• Study Completion: October 6, 2017
• Last Updated: October 21, 2024

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)