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

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: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Placebo; Drug: ASP2151

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan
    • Site JP00001

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: June 7, 2016
• First Submitted That Met QC Criteria: June 7, 2016
• First Posted (Estimate): June 10, 2016

Study Record Updates

• Last Update Posted (Estimate): August 29, 2016
• Last Update Submitted That Met QC Criteria: August 25, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; ASP2151; Healthy non-elderly and elderly subjects
• Other Study ID Numbers: 15L-CL-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED