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

October 18, 2024 updated by: Astellas Pharma Inc

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Sumida, Tokyo, Japan
        • Site JP00001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 44 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ASP8062 lower dose
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 will be administered orally.
Experimental: ASP8062 middle dose
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 will be administered orally.
Experimental: ASP8062 higher dose
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 will be administered orally.
Placebo Comparator: 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.
Drug: Placebo
Placebo will be administered orally.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety assessed by incidence of adverse events
Time Frame: Up to Day 38
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
Time Frame: Up to Day 38
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
Time Frame: Up to Day 38
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
Time Frame: Up to Day 38
To assess the vital sign as a criteria of safety and tolerability variables.
Up to Day 38
Orthostatic challenge tests
Time Frame: Up to Day 20
To assess the orthostatic challenge tests as a criteria of safety and tolerability variables.
Up to Day 20
Safety assessed by laboratory tests: Hematology
Time Frame: Up to Day 38
To assess hematology as a criteria of safety and tolerability variables.
Up to Day 38
Safety assessed by laboratory tests: Biochemistry
Time Frame: Up to Day 38
To assess biochemistry as a criteria of safety and tolerability variables.
Up to Day 38
Safety assessed by laboratory tests: Urinalysis
Time Frame: Up to Day 38
To assess urinalysis as a criteria of safety and tolerability variables.
Up to Day 38
Safety assessed by 12-lead electrocardiogram
Time Frame: Up to Day 21
To assess the cardiovascular system functioning as a criteria of safety and tolerability variables.
Up to Day 21
Columbia-Suicide Severity Rating Scale
Time Frame: Up to Day 20
To assess the suicide risk
Up to Day 20
Safety assessed by body weight
Time Frame: Up to Day 38
To assess the body weight as a criteria of safety and tolerability variables.
Up to Day 38

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK) parameter for ASP8062: Maximum observed concentration (Cmax)
Time Frame: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
Up to Day 38
PK parameter for ASP8062: Time to maximum concentration (Tmax)
Time Frame: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
Up to Day 38
PK parameter for ASP8062: Terminal elimination half-life (t1/2)
Time Frame: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
Up to Day 38
PK parameter for ASP8062: Apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F)
Time Frame: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
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)
Time Frame: Up to Day 6
To assess the PK of ASP8062 in single dose part.
Up to Day 6
PK parameter for ASP8062: AUC from the time of dosing extrapolated to time infinity (AUCinf)
Time Frame: Up to Day 6
To assess the PK of ASP8062 in single dose part.
Up to Day 6
PK parameter for ASP8062: AUC from the time of dosing to the last measurable concentration (AUClast)
Time Frame: Up to Day 6
To assess the PK of ASP8062 in single dose part.
Up to Day 6
PK parameter for ASP8062: Time point prior to the time point corresponding to the first measurable (non-zero) concentration (tlag)
Time Frame: Up to Day 6
To assess the PK of ASP8062 in single dose part.
Up to Day 6
PK parameter for ASP8062: Apparent volume of distribution during the terminal elimination phase after single extra-vascular dosing (Vz/F)
Time Frame: Up to Day 6
To assess the PK of ASP8062 in single dose part.
Up to Day 6
PK parameter for ASP8062: AUC from the time of dosing to the start of the next dosing interval (AUCtau)
Time Frame: From Day 7 to Day 38
To assess the PK of ASP8062 in multiple dose part.
From Day 7 to Day 38
PK parameter for ASP8062: Concentration immediately prior to dosing at multiple dosing (Ctrough)
Time Frame: From Day 7 to Day 20
To assess the PK of ASP8062 in multiple dose part.
From Day 7 to Day 20
PK parameter for ASP8062: Percentage of AUCinf that is estimated by extrapolation (AUCinf (%extrap))
Time Frame: Up to Day 6
To assess the PK of ASP8062 in single dose part
Up to Day 6
PK parameter for ASP8062: Terminal elimination rate constant (Lambda z)
Time Frame: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
Up to Day 38
PK parameter for ASP8062: Time of the last measurable concentration (tlast)
Time Frame: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
Up to Day 38
Accumulation Ratio (Rac) of Cmax
Time Frame: From Day 7 to Day 38
To assess the PK of ASP8062 in multiple dose part.
From Day 7 to Day 38
Rac of AUC
Time Frame: From Day 7 to Day 38
To assess the PK of ASP8062 in multiple dose part.
From Day 7 to Day 38
Peak-Trough Ratio for last dosing in multiple dose part
Time Frame: Day 20 and Day 21
To assess the PK of ASP8062 in multiple dose part.
Day 20 and Day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Astellas Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 6, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 6, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 8062-CL-0004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteers

Clinical Trials on ASP8062

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings