Herpes Genitalis, Herpes Zoster
Conditions
Keywords
Safety of ASP2151, Phase 1, Pharmacokinetics, Healthy male subjects, Tolerability, Food effect of ASP2151
Brief summary
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.
Detailed description
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.
Interventions
DRUGPlacebo
Oral
DRUGASP2151
Oral
Sponsors
Astellas Pharma Europe Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs) | Up to Day 15 of each treatment period | For Part 1 and Part 2 |
| Safety assessed by 12- lead electrocardiogram (ECG) | Up to Day 15 of each treatment period | For Part 1 and Part 2 |
| Safety assessed by vital sign measurement: blood pressure | Up to Day 15 of each treatment period | For Part 1 and Part 2 includes systolic and blood diastolic pressure |
| Safety assessed by vital sign measurement: pulse rate | Up to Day 15 of each treatment period | For Part 1 and Part 2 |
| Safety assessed by laboratory test: biochemical | Up to Day 15 of each treatment period | For Part 1 and Part 2 |
| Safety assessed by laboratory test: hematological | Up to Day 15 of each treatment period | For Part 1 and Part 2 |
| Safety assessed by laboratory test: serology | Up to Day 15 of each treatment period | For Part 1 and Part 2 |
| Safety assessed by laboratory test: urinalysis | Up to Day 15 of each treatment period | For Part 1 and Part 2 |
| Safety assessed by physical exam: body weight | Up to Day 15 of each treatment period | For Part 1 and Part 2 |
| Safety assessed by physical exam: height | Up to Day 15 of each treatment period | For Part 1 and Part 2 |
| Safety assessed by physical exam: body mass index (BMI) | Up to Day 15 of each treatment period | For Part 1 and Part 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of ASP2151 in plasma: AUC0-inf | Up to 48 hours in each treatment period | For Part 1 and 2. AUC0-inf: Area under the concentration time curve from the time of dosing extrapolated to time infinity |
| Pharmacokinetics of ASP2151 in urine: CLr | Up to 48 hours in each treatment period | For Part 1 and 2. CLr: Renal clearance |
| Pharmacokinetics of ASP2151 in plasma: t1/2 | Up to 48 hours in each treatment period | For Part 1 and 2. t1/2: Apparent terminal elimination half-life |
| Pharmacokinetics of ASP2151 in plasma: Cmax | Up to 48 hours in each treatment period | For Part 1 and 2. Cmax: Maximum concentration |
| Pharmacokinetics of ASP2151 in plasma: tmax | Up to 48 hours in each treatment period | For Part 1 and 2. tmax: The time after dosing when Cmax occurs |
| Pharmacokinetics of ASP2151 in plasma: CL/F | Up to 48 hours in each treatment period | For Part 1 and 2. CL/F: Oral clearance |
| Pharmacokinetics of ASP2151 in plasma: Vz/F | Up to 48 hours in each treatment period | For Part 1 and 2. Vz/F: Apparent volume of distribution |
| Pharmacokinetics of ASP2151 in plasma: AUClast | Up to 48 hours in each treatment period | For Part 1 and 2. AUClast: Area under the plasma concentration time curve from time of dosing up to the last quantifiable sample |
| Pharmacokinetics of ASP2151 in plasma: tlag | Up to 48 hours in each treatment period | For Part 1 and 2. tlag: Absorption lag time |
| Pharmacokinetics of ASP2151 in urine: Aelast | Up to 48 hours in each treatment period | For Part 1 and 2. Aelast: Amount excreted unchanged in urine from time of dosing up to the last quantifiable sample |
| Pharmacokinetics of ASP2151 in urine: Ae0-inf | Up to 48 hours in each treatment period | For Part 1 and 2. Ae0-inf: Amount excreted unchanged in urine from time of dosing extrapolated to infinity |
| Pharmacokinetics of ASP2151 in urine: Ae% | Up to 48 hours in each treatment period | For Part 1 and 2. Ae%: Percent of ASP2151 amount excreted in urine |
Countries
France
Outcome results
None listed