Study to Evaluate the Safety and Pharmacokinetics of Single Doses of ASP2151 in Healthy Male Subjects and the Effects of Food

Astellas Pharma Europe Ltd.72 enrolled

Overview

The objective of this study is to evaluate the safety and tolerability of single rising doses of ASP2151 under fasted condition in healthy male subjects. The study will also evaluate the pharmacokinetics (PK) of a single dose of ASP2151 under fasted versus fed conditions in healthy male subjects.

Study will be divided into two parts. Part 1 will evaluate the safety and tolerability of ASP2151 single rising doses in groups A-H in fasted condition and to determine the maximum tolerable dose (MTD) if possible. Part 2 will evaluate the effect of fasted versus fed conditions on the safety, tolerability and PK of a single dose of ASP2151 in two treatment cycles. The wash-out period between the two treatment cycles will be at least 5 days and not shorter than five times the average elimination half-life of ASP2151, as determined in part 1 of the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Herpes Genitalis Herpes Zoster

Interventions

ASP2151DRUG

Oral

PlaceboDRUG

Oral

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Body weight between 60 and 100 kg, and BMI between 18 and 30 kg/m2 inclusive Exclusion Criteria: * Known or suspected hypersensitivity to ASP2151 or any components of the formulation used * Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug * Any clinically significant history of genital herpes symptoms and/or herpes zoster symptoms in the 3 months prior to admission to the Clinical Unit * Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic * Abnormal pulse rate and/or blood pressure measurements at the pre-study visit as follows: Pulse rate \<40 or \>90 bpm (beats per minute); mean systolic blood pressure \<90 or \>140 mmHg (millimeter of mercury); mean diastolic blood pressure \<40 or \>95 mmHg * Regular use of any prescribed or OTC (over the counter) drugs in the 4 weeks prior to admission to the Clinical Unit OR any use of such drugs in the 2 weeks prior to admission to the Clinical Unit * Any use of drugs of abuse within 3 months prior to admission to the Clinical Unit * History of smoking more than 10 cigarettes per day within 3 months prior to admission to the Clinical Unit * History of drinking more than 21 units of alcohol per week within 3 months prior to admission to the Clinical Unit * Donation of blood or blood products within 3 months, prior to admission to the Clinical Unit * Positive serology test for HBsAg (Hepatitis B surface antigen), HAV IgM (Hepatitis A Virus), anti-HCV (Hepatitis C Virus) or anti-HIV (Human Immunodeficiency Virus) 1 and 2 * Not willing or able to swallow size 00 capsules

Locations (1)

Site FR1717

Paris, France

Outcomes

Primary Outcomes

Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs)

For Part 1 and Part 2

Time frame: Up to Day 15 of each treatment period

Safety assessed by 12- lead electrocardiogram (ECG)

For Part 1 and Part 2

Time frame: Up to Day 15 of each treatment period

Safety assessed by vital sign measurement: blood pressure

For Part 1 and Part 2 includes systolic and blood diastolic pressure

Time frame: Up to Day 15 of each treatment period

Safety assessed by vital sign measurement: pulse rate

For Part 1 and Part 2

Time frame: Up to Day 15 of each treatment period

Safety assessed by laboratory test: biochemical

For Part 1 and Part 2

Time frame: Up to Day 15 of each treatment period

Safety assessed by laboratory test: hematological

For Part 1 and Part 2

Time frame: Up to Day 15 of each treatment period

Safety assessed by laboratory test: serology

For Part 1 and Part 2

Time frame: Up to Day 15 of each treatment period

Safety assessed by laboratory test: urinalysis

For Part 1 and Part 2

Time frame: Up to Day 15 of each treatment period

Safety assessed by physical exam: body weight

Data from ClinicalTrials.gov

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Secondary Outcomes

Pharmacokinetics of ASP2151 in plasma: AUC0-inf

For Part 1 and 2. AUC0-inf: Area under the concentration time curve from the time of dosing extrapolated to time infinity