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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02796118
• Other study ID #: 15L-CL-003
• Status: Completed
• Phase: Phase 1
• First received: June 7, 2016
• Last updated: August 25, 2016
• Start date: July 2006
• Est. completion date: October 2006

Study information

• Verified date: August 2016
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• ASP2151
Oral
• Placebo
Oral

Locations

Country	Name	City	State
Japan	Site JP00001	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of ASP2151 in plasma: Cmax	Cmax: Maximum concentration	Up to Day 9	No
Primary	Pharmacokinetics of ASP2151 in plasma: tmax	tmax: The time after dosing when Cmax occurs	Up to Day 9	No
Primary	Pharmacokinetics of ASP2151 in plasma: t1/2	t1/2: Apparent terminal elimination half-life	Up to Day 9	No
Primary	Pharmacokinetics of ASP2151 in plasma: C24	C24: Concentration at 24hours after dosing	Up to Day 9	No
Primary	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	No
Primary	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	No
Primary	Pharmacokinetics of ASP2151 in plasma: CL/F	CL/F: Apparent total systemic clearance	Up to Day 9	No
Primary	Pharmacokinetics of ASP2151 in urine: Ae	Ae: Amount excreted in urine	Up to Day 9	No
Primary	Pharmacokinetics of ASP2151 in urine: Cumulative Ae		Up to Day 9	No
Primary	Pharmacokinetics of ASP2151 in urine: Ae%	Ae%: Percent of ASP2151 amount excreted in urine	Up to Day 9	No
Primary	Pharmacokinetics of ASP2151 in urine: Cumulative Ae%		Up to Day 9	No
Primary	Pharmacokinetics of ASP2151 in urine: CLR	CLR: Renal clearance	Up to Day 9	No
Primary	Safety assessed by laboratory test: Hematology		Up to Day 14	No
Primary	Safety assessed by laboratory test: blood biochemistry		Up to Day 14	No
Primary	Safety assessed by laboratory test: urinalysis		Up to Day 14	No
Primary	Safety assessed by Vital sign measurement: axillary body temperature		Up to Day 14	No
Primary	Safety assessed by vital sign measurement: supine blood pressure		Up to Day 14	No
Primary	Safety assessed by vital sign measurement: supine pulse rate		Up to Day 14	No
Primary	Safety assessed by Standard 12-lead electrocardiogram		Up to Day 14	No
Primary	Safety assessed by Standard 12-lead electrocardiogram for QT assessment		Up to Day 14	No
Primary	Safety assessed by ophthalmological examination		Up to Day 14	No
Primary	Safety assessed by incidence of adverse events		Up to Day 14	No