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

Astellas

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: ASP2151; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02796118

15L-CL-003

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Male

Ages: 20 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 6 patient groups, including a placebo group

ASP2151 Low dose in non-elderly subjects group

Experimental group

Description:

Subjects will receive ASP2151 daily on Days 1 to 7.

Treatment:

Drug: ASP2151

ASP2151 High dose in non-elderly subjects group

Experimental group

Description:

Subjects will receive ASP2151 daily on Days 1 to 7.

Treatment:

Drug: ASP2151

ASP2151 Low dose in elderly subjects group

Experimental group

Description:

Subjects will receive ASP2151 daily on Days 1 to 7.

Treatment:

Drug: ASP2151

ASP2151 High dose in elderly subjects group

Experimental group

Description:

Subjects will receive ASP2151 daily on Days 1 to 7.

Treatment:

Drug: ASP2151

Placebo in non-elderly subjects group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Placebo in elderly subjects group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo