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

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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