Clinical trial NCT02852876: Study to Evaluate the Safety and Pharmacokinetics of Single Doses of ASP2151 in Healthy Male Subjects and the Effects of Food
Official title: A Double-Blind, Placebo-Controlled Single Dose Escalating Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP2151 in Healthy Male Subjects, Followed by an Open, Two-Period Crossover Study to Assess the Effect of Fed Conditions on the Safety, Tolerability and Pharmacokinetics of ASP2151
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Herpes Genitalis
Herpes Zoster
Keywords: Safety of ASP2151
Phase 1
Pharmacokinetics
Healthy male subjects
Tolerability
Food effect of ASP2151
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2016-08-02
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs)
timeFrame: Up to Day 15 of each treatment period
measure: Safety assessed by 12- lead electrocardiogram (ECG)
timeFrame: Up to Day 15 of each treatment period
measure: Safety assessed by vital sign measurement: blood pressure
timeFrame: Up to Day 15 of each treatment period
measure: Safety assessed by vital sign measurement: pulse rate
timeFrame: Up to Day 15 of each treatment period
measure: Safety assessed by laboratory test: biochemical
timeFrame: Up to Day 15 of each treatment period
measure: Safety assessed by laboratory test: hematological
timeFrame: Up to Day 15 of each treatment period
measure: Safety assessed by laboratory test: serology
timeFrame: Up to Day 15 of each treatment period
measure: Safety assessed by laboratory test: urinalysis
timeFrame: Up to Day 15 of each treatment period
measure: Safety assessed by physical exam: body weight
timeFrame: Up to Day 15 of each treatment period
measure: Safety assessed by physical exam: height
timeFrame: Up to Day 15 of each treatment period
measure: Safety assessed by physical exam: body mass index (BMI)
timeFrame: Up to Day 15 of each treatment period
Secondary outcomes:
measure: Pharmacokinetics of ASP2151 in plasma: AUC0-inf
timeFrame: Up to 48 hours in each treatment period
measure: Pharmacokinetics of ASP2151 in plasma: t1/2
timeFrame: Up to 48 hours in each treatment period
measure: Pharmacokinetics of ASP2151 in plasma: Cmax
timeFrame: Up to 48 hours in each treatment period
measure: Pharmacokinetics of ASP2151 in plasma: tmax
timeFrame: Up to 48 hours in each treatment period
measure: Pharmacokinetics of ASP2151 in plasma: CL/F
timeFrame: Up to 48 hours in each treatment period
measure: Pharmacokinetics of ASP2151 in plasma: Vz/F
timeFrame: Up to 48 hours in each treatment period
measure: Pharmacokinetics of ASP2151 in plasma: AUClast
timeFrame: Up to 48 hours in each treatment period
measure: Pharmacokinetics of ASP2151 in plasma: tlag
timeFrame: Up to 48 hours in each treatment period
measure: Pharmacokinetics of ASP2151 in urine: Aelast
timeFrame: Up to 48 hours in each treatment period
measure: Pharmacokinetics of ASP2151 in urine: Ae0-inf
timeFrame: Up to 48 hours in each treatment period
measure: Pharmacokinetics of ASP2151 in urine: Ae%
timeFrame: Up to 48 hours in each treatment period
measure: Pharmacokinetics of ASP2151 in urine: CLr
timeFrame: Up to 48 hours in each treatment period
Other outcomes:
Locations:
city: Paris
country: France
facility: Site FR1717
Study officials:
affiliation: Astellas Pharma Clinical Pharmacology & Exploratory Dev.
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.