Clinical trial NCT02796118: Study to Evaluate the Safety and Pharmacokinetics of ASP2151 in Healthy Non-elderly and Elderly Subjects
Official title: ASP2151 Phase 1 Study - Multiple Oral Dosing Study in Healthy Non-elderly Male and Elderly Male Japanese Subjects-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Pharmacokinetics
Healthy non-elderly and elderly subjects
ASP2151
Safety
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2016-06-10
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Pharmacokinetics of ASP2151 in plasma: Cmax
timeFrame: Up to Day 9
measure: Pharmacokinetics of ASP2151 in plasma: tmax
timeFrame: Up to Day 9
measure: Pharmacokinetics of ASP2151 in plasma: t1/2
timeFrame: Up to Day 9
measure: Pharmacokinetics of ASP2151 in plasma: C24
timeFrame: Up to Day 9
measure: Pharmacokinetics of ASP2151 in plasma: AUC24
timeFrame: Up to Day 9
measure: Pharmacokinetics of ASP2151 in plasma: AUCinf
timeFrame: Up to Day 9
measure: Pharmacokinetics of ASP2151 in plasma: CL/F
timeFrame: Up to Day 9
measure: Pharmacokinetics of ASP2151 in urine: Ae
timeFrame: Up to Day 9
measure: Pharmacokinetics of ASP2151 in urine: Cumulative Ae
timeFrame: Up to Day 9
measure: Pharmacokinetics of ASP2151 in urine: Ae%
timeFrame: Up to Day 9
measure: Pharmacokinetics of ASP2151 in urine: Cumulative Ae%
timeFrame: Up to Day 9
measure: Pharmacokinetics of ASP2151 in urine: CLR
timeFrame: Up to Day 9
measure: Safety assessed by laboratory test: Hematology
timeFrame: Up to Day 14
measure: Safety assessed by laboratory test: blood biochemistry
timeFrame: Up to Day 14
measure: Safety assessed by laboratory test: urinalysis
timeFrame: Up to Day 14
measure: Safety assessed by Vital sign measurement: axillary body temperature
timeFrame: Up to Day 14
measure: Safety assessed by vital sign measurement: supine blood pressure
timeFrame: Up to Day 14
measure: Safety assessed by vital sign measurement: supine pulse rate
timeFrame: Up to Day 14
measure: Safety assessed by Standard 12-lead electrocardiogram
timeFrame: Up to Day 14
measure: Safety assessed by Standard 12-lead electrocardiogram for QT assessment
timeFrame: Up to Day 14
measure: Safety assessed by ophthalmological examination
timeFrame: Up to Day 14
measure: Safety assessed by incidence of adverse events
timeFrame: Up to Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Site JP00001
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.