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

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ClinicalTrials.gov Identifier: NCT02796118
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: ASP2151 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: ASP2151 Phase 1 Study - Multiple Oral Dosing Study in Healthy Non-elderly Male and Elderly Male Japanese Subjects-
Study Start Date : July 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

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




Primary Outcome Measures :
  1. Pharmacokinetics of ASP2151 in plasma: Cmax [ Time Frame: Up to Day 9 ]
    Cmax: Maximum concentration

  2. Pharmacokinetics of ASP2151 in plasma: tmax [ Time Frame: Up to Day 9 ]
    tmax: The time after dosing when Cmax occurs

  3. Pharmacokinetics of ASP2151 in plasma: t1/2 [ Time Frame: Up to Day 9 ]
    t1/2: Apparent terminal elimination half-life

  4. Pharmacokinetics of ASP2151 in plasma: C24 [ Time Frame: Up to Day 9 ]
    C24: Concentration at 24hours after dosing

  5. Pharmacokinetics of ASP2151 in plasma: AUC24 [ Time Frame: Up to Day 9 ]
    AUC24: Area under the concentration-time curve from the time of dosing to 24hours after dosing

  6. Pharmacokinetics of ASP2151 in plasma: AUCinf [ Time Frame: Up to Day 9 ]
    AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity

  7. Pharmacokinetics of ASP2151 in plasma: CL/F [ Time Frame: Up to Day 9 ]
    CL/F: Apparent total systemic clearance

  8. Pharmacokinetics of ASP2151 in urine: Ae [ Time Frame: Up to Day 9 ]
    Ae: Amount excreted in urine

  9. Pharmacokinetics of ASP2151 in urine: Cumulative Ae [ Time Frame: Up to Day 9 ]
  10. Pharmacokinetics of ASP2151 in urine: Ae% [ Time Frame: Up to Day 9 ]
    Ae%: Percent of ASP2151 amount excreted in urine

  11. Pharmacokinetics of ASP2151 in urine: Cumulative Ae% [ Time Frame: Up to Day 9 ]
  12. Pharmacokinetics of ASP2151 in urine: CLR [ Time Frame: Up to Day 9 ]
    CLR: Renal clearance

  13. Safety assessed by laboratory test: Hematology [ Time Frame: Up to Day 14 ]
  14. Safety assessed by laboratory test: blood biochemistry [ Time Frame: Up to Day 14 ]
  15. Safety assessed by laboratory test: urinalysis [ Time Frame: Up to Day 14 ]
  16. Safety assessed by Vital sign measurement: axillary body temperature [ Time Frame: Up to Day 14 ]
  17. Safety assessed by vital sign measurement: supine blood pressure [ Time Frame: Up to Day 14 ]
  18. Safety assessed by vital sign measurement: supine pulse rate [ Time Frame: Up to Day 14 ]
  19. Safety assessed by Standard 12-lead electrocardiogram [ Time Frame: Up to Day 14 ]
  20. Safety assessed by Standard 12-lead electrocardiogram for QT assessment [ Time Frame: Up to Day 14 ]
  21. Safety assessed by ophthalmological examination [ Time Frame: Up to Day 14 ]
  22. Safety assessed by incidence of adverse events [ Time Frame: Up to Day 14 ]


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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796118


Locations
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Japan
Site JP00001
Osaka, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Medical Director Astellas Pharma Inc

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT02796118     History of Changes
Other Study ID Numbers: 15L-CL-003
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: August 29, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Astellas Pharma Inc:
Pharmacokinetics
Healthy non-elderly and elderly subjects
ASP2151
Safety