Study to Evaluate the Safety and Pharmacokinetics of ASP2151 in Healthy Non-elderly and Elderly Subjects

August 25, 2016 updated by: Astellas Pharma Inc

ASP2151 Phase 1 Study - Multiple Oral Dosing Study in Healthy Non-elderly Male and Elderly Male Japanese Subjects-

The objective of this study is to evaluate the safety and the pharmacokinetics of ASP2151 after multiple oral dosing of ASP2151 in healthy non-elderly male and elderly male Japanese subjects, and to compare the pharmacokinetics of ASP2151 in healthy non-elderly male and elderly male Japanese 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
      • Osaka, 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 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Body weight: ≥50.0 kg and <85.0 kg
  • Body mass index (BMI): ≥17.6 and <26.4 kg/m2

Exclusion Criteria:

  • Subjects with a complication of any diseases
  • Subjects with a history of hepatic disease
  • Subjects with a history of heart disease
  • Subjects with a history of respiratory disease
  • Subjects with a history of alimentary disease
  • Subjects with a history of renal disease
  • Subjects with a history of cerebrovascular disorder
  • Subjects with a history of malignant tumor
  • Subjects with a history of drug allergies or allergies disorders excluding pollinosis
  • Subjects with a history of drug dependency or alcohol dependence syndrome
  • Subjects who developed genital herpes or herpes zoster within 90 days before the initial dosing
  • Subjects who do not meet any of the criteria for laboratory tests
  • Subjects who received medications within 14 days before the initial dosing.
  • Subjects who received any investigational drugs in other clinical trials or post-marketing studies within 120 days before screening or the initial dosing
  • Excessive alcohol drinking or smoking habit
  • Subjects who previously received administration of ASP2151 (including placebo)
  • Abnormalities detected on an ophthalmological examination
  • Subjects who deviate from the normal range of standard 12-lead ECG at screening

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: Double

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: ASP2151 Low dose in non-elderly subjects group
Subjects will receive ASP2151 daily on Days 1 to 7.
Drug: ASP2151
Oral
Experimental: ASP2151 High dose in non-elderly subjects group
Subjects will receive ASP2151 daily on Days 1 to 7.
Drug: ASP2151
Oral
Experimental: ASP2151 Low dose in elderly subjects group
Subjects will receive ASP2151 daily on Days 1 to 7.
Drug: ASP2151
Oral
Experimental: ASP2151 High dose in elderly subjects group
Subjects will receive ASP2151 daily on Days 1 to 7.
Drug: ASP2151
Oral
Placebo Comparator: Placebo in non-elderly subjects group
Subjects will receive matching placebo daily on Days 1 to 7.
Drug: Placebo
Oral
Placebo Comparator: Placebo in elderly subjects group
Subjects will receive matching placebo daily on Days 1 to 7.
Drug: Placebo
Oral

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
Pharmacokinetics of ASP2151 in plasma: Cmax
Time Frame: Up to Day 9
Cmax: Maximum concentration
Up to Day 9
Pharmacokinetics of ASP2151 in plasma: tmax
Time Frame: Up to Day 9
tmax: The time after dosing when Cmax occurs
Up to Day 9
Pharmacokinetics of ASP2151 in plasma: t1/2
Time Frame: Up to Day 9
t1/2: Apparent terminal elimination half-life
Up to Day 9
Pharmacokinetics of ASP2151 in plasma: C24
Time Frame: Up to Day 9
C24: Concentration at 24hours after dosing
Up to Day 9
Pharmacokinetics of ASP2151 in plasma: AUC24
Time Frame: Up to Day 9
AUC24: Area under the concentration-time curve from the time of dosing to 24hours after dosing
Up to Day 9
Pharmacokinetics of ASP2151 in plasma: AUCinf
Time Frame: Up to Day 9
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
Up to Day 9
Pharmacokinetics of ASP2151 in plasma: CL/F
Time Frame: Up to Day 9
CL/F: Apparent total systemic clearance
Up to Day 9
Pharmacokinetics of ASP2151 in urine: Ae
Time Frame: Up to Day 9
Ae: Amount excreted in urine
Up to Day 9
Pharmacokinetics of ASP2151 in urine: Cumulative Ae
Time Frame: Up to Day 9
Up to Day 9
Pharmacokinetics of ASP2151 in urine: Ae%
Time Frame: Up to Day 9
Ae%: Percent of ASP2151 amount excreted in urine
Up to Day 9
Pharmacokinetics of ASP2151 in urine: Cumulative Ae%
Time Frame: Up to Day 9
Up to Day 9
Pharmacokinetics of ASP2151 in urine: CLR
Time Frame: Up to Day 9
CLR: Renal clearance
Up to Day 9
Safety assessed by laboratory test: Hematology
Time Frame: Up to Day 14
Up to Day 14
Safety assessed by laboratory test: blood biochemistry
Time Frame: Up to Day 14
Up to Day 14
Safety assessed by laboratory test: urinalysis
Time Frame: Up to Day 14
Up to Day 14
Safety assessed by Vital sign measurement: axillary body temperature
Time Frame: Up to Day 14
Up to Day 14
Safety assessed by vital sign measurement: supine blood pressure
Time Frame: Up to Day 14
Up to Day 14
Safety assessed by vital sign measurement: supine pulse rate
Time Frame: Up to Day 14
Up to Day 14
Safety assessed by Standard 12-lead electrocardiogram
Time Frame: Up to Day 14
Up to Day 14
Safety assessed by Standard 12-lead electrocardiogram for QT assessment
Time Frame: Up to Day 14
Up to Day 14
Safety assessed by ophthalmological examination
Time Frame: Up to Day 14
Up to Day 14
Safety assessed by incidence of adverse events
Time Frame: Up to Day 14
Up to Day 14

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

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.
July 1, 2006

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 1, 2006

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 1, 2006

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 7, 2016

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 7, 2016

First Posted (Estimate)

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 10, 2016

Study Record Updates

Last Update Posted (Estimate)

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.
August 29, 2016

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.
August 25, 2016

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.
August 1, 2016

More Information

Terms related to this study

Keywords

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.
  • 15L-CL-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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