NCT02796118

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
Last Updated

August 29, 2016

Status Verified

August 1, 2016

Enrollment Period

3 months

First QC Date

June 7, 2016

Last Update Submit

August 25, 2016

Conditions

Healthy Subjects

Keywords

PharmacokineticsHealthy non-elderly and elderly subjectsASP2151Safety

Outcome Measures

Primary Outcomes (22)

  • Pharmacokinetics of ASP2151 in plasma: Cmax

    Cmax: Maximum concentration

    Up to Day 9

  • Pharmacokinetics of ASP2151 in plasma: tmax

    tmax: The time after dosing when Cmax occurs

    Up to Day 9

  • Pharmacokinetics of ASP2151 in plasma: t1/2

    t1/2: Apparent terminal elimination half-life

    Up to Day 9

  • Pharmacokinetics of ASP2151 in plasma: C24

    C24: Concentration at 24hours after dosing

    Up to Day 9

  • Pharmacokinetics of ASP2151 in plasma: AUC24

    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

    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

    CL/F: Apparent total systemic clearance

    Up to Day 9

  • Pharmacokinetics of ASP2151 in urine: Ae

    Ae: Amount excreted in urine

    Up to Day 9

  • Pharmacokinetics of ASP2151 in urine: Cumulative Ae

    Up to Day 9

  • Pharmacokinetics of ASP2151 in urine: Ae%

    Ae%: Percent of ASP2151 amount excreted in urine

    Up to Day 9

  • Pharmacokinetics of ASP2151 in urine: Cumulative Ae%

    Up to Day 9

  • Pharmacokinetics of ASP2151 in urine: CLR

    CLR: Renal clearance

    Up to Day 9

  • Safety assessed by laboratory test: Hematology

    Up to Day 14

  • Safety assessed by laboratory test: blood biochemistry

    Up to Day 14

  • Safety assessed by laboratory test: urinalysis

    Up to Day 14

  • Safety assessed by Vital sign measurement: axillary body temperature

    Up to Day 14

  • Safety assessed by vital sign measurement: supine blood pressure

    Up to Day 14

  • Safety assessed by vital sign measurement: supine pulse rate

    Up to Day 14

  • Safety assessed by Standard 12-lead electrocardiogram

    Up to Day 14

  • Safety assessed by Standard 12-lead electrocardiogram for QT assessment

    Up to Day 14

  • Safety assessed by ophthalmological examination

    Up to Day 14

  • Safety assessed by incidence of adverse events

    Up to Day 14

Study Arms (6)

ASP2151 Low dose in non-elderly subjects group

EXPERIMENTAL

Subjects will receive ASP2151 daily on Days 1 to 7.

Drug: ASP2151

ASP2151 High dose in non-elderly subjects group

EXPERIMENTAL

Subjects will receive ASP2151 daily on Days 1 to 7.

Drug: ASP2151

ASP2151 Low dose in elderly subjects group

EXPERIMENTAL

Subjects will receive ASP2151 daily on Days 1 to 7.

Drug: ASP2151

ASP2151 High dose in elderly subjects group

EXPERIMENTAL

Subjects will receive ASP2151 daily on Days 1 to 7.

Drug: ASP2151

Placebo in non-elderly subjects group

PLACEBO COMPARATOR

Subjects will receive matching placebo daily on Days 1 to 7.

Drug: Placebo

Placebo in elderly subjects group

PLACEBO COMPARATOR

Subjects will receive matching placebo daily on Days 1 to 7.

Drug: Placebo

Interventions

ASP2151DRUG

Oral

ASP2151 High dose in elderly subjects groupASP2151 High dose in non-elderly subjects groupASP2151 Low dose in elderly subjects groupASP2151 Low dose in non-elderly subjects group
PlaceboDRUG

Oral

Placebo in elderly subjects groupPlacebo in non-elderly subjects group

Eligibility Criteria

Age20 Years - 79 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site JP00001

Osaka, Osaka, Japan

Location

Related Publications (1)

  • Kusawake T, Keirns JJ, Kowalski D, den Adel M, Groenendaal-van de Meent D, Takada A, Ohtsu Y, Katashima M. Pharmacokinetics and Safety of Amenamevir in Healthy Subjects: Analysis of Four Randomized Phase 1 Studies. Adv Ther. 2017 Dec;34(12):2625-2637. doi: 10.1007/s12325-017-0642-4. Epub 2017 Nov 13.

    PMID: 29134426DERIVED

MeSH Terms

Interventions

ASP2151

Study Officials

  • Medical Director

    Astellas Pharma Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2016

First Posted

June 10, 2016

Study Start

July 1, 2006

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

August 29, 2016

Record last verified: 2016-08

Locations

JP(1)