- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02852876
Study to Evaluate the Safety and Pharmacokinetics of Single Doses of ASP2151 in Healthy Male Subjects and the Effects of Food
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
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Paris, France, 75015
- Site FR1717
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part 1: ASP2151 Single Ascending Dose Group A (Fasting)
Participants will receive single dose of ASP2151 assigned to Group A on day 1
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Oral
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Experimental: Part 1: ASP2151 Single Ascending Dose Group B (Fasting)
Participants will receive single dose of ASP2151 assigned to Group B on day 1
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Oral
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Experimental: Part 1: ASP2151 Single Ascending Dose Group C (Fasting)
Participants will receive single dose of ASP2151 assigned to Group C on day 1
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Oral
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Experimental: Part 1: ASP2151 Single Ascending Dose Group D (Fasting)
Participants will receive single dose of ASP2151 assigned to Group D on day 1
|
Oral
|
Experimental: Part 1: ASP2151 Single Ascending Dose Group E (Fasting)
Participants will receive single dose of ASP2151 assigned to Group E on day 1
|
Oral
|
Experimental: Part 1: ASP2151 Single Ascending Dose Group F (Fasting)
Participants will receive single dose of ASP2151 assigned to Group F on day 1
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Oral
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Placebo Comparator: Part 1: Placebo Single Ascending Dose (Fasting)
Participants will receive single dose of matching placebo on day 1
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Oral
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Experimental: Part 2: ASP2151 (Fasting)
Participants will receive a single dose of ASP2151 under fasted conditions on day 1 in the first treatment period (period 1).
Following a wash-out period of at least five days, the treatment will be repeated in the reverse orientation (period 2)
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Oral
|
Experimental: Part 2: ASP2151 (Fed)
Participants will receive a single dose of ASP2151 under fed conditions on day 1 in the first treatment period (period 1).
Following a wash-out period of at least five days, the treatment will be repeated in the reverse orientation (period 2)
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Oral
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Experimental: Part 1: ASP2151 Single Ascending Dose Group G (Fasting)
Participants will receive single dose of ASP2151 assigned to Group G on day 1
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Oral
|
Experimental: Part 1: ASP2151 Single Ascending Dose Group H (Fasting)
Participants will receive single dose of ASP2151 assigned to Group H on day 1
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Oral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs)
Time Frame: Up to Day 15 of each treatment period
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For Part 1 and Part 2
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Up to Day 15 of each treatment period
|
Safety assessed by 12- lead electrocardiogram (ECG)
Time Frame: Up to Day 15 of each treatment period
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For Part 1 and Part 2
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Up to Day 15 of each treatment period
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Safety assessed by vital sign measurement: blood pressure
Time Frame: Up to Day 15 of each treatment period
|
For Part 1 and Part 2 includes systolic and blood diastolic pressure
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Up to Day 15 of each treatment period
|
Safety assessed by vital sign measurement: pulse rate
Time Frame: Up to Day 15 of each treatment period
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For Part 1 and Part 2
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Up to Day 15 of each treatment period
|
Safety assessed by laboratory test: biochemical
Time Frame: Up to Day 15 of each treatment period
|
For Part 1 and Part 2
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Up to Day 15 of each treatment period
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Safety assessed by laboratory test: hematological
Time Frame: Up to Day 15 of each treatment period
|
For Part 1 and Part 2
|
Up to Day 15 of each treatment period
|
Safety assessed by laboratory test: serology
Time Frame: Up to Day 15 of each treatment period
|
For Part 1 and Part 2
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Up to Day 15 of each treatment period
|
Safety assessed by laboratory test: urinalysis
Time Frame: Up to Day 15 of each treatment period
|
For Part 1 and Part 2
|
Up to Day 15 of each treatment period
|
Safety assessed by physical exam: body weight
Time Frame: Up to Day 15 of each treatment period
|
For Part 1 and Part 2
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Up to Day 15 of each treatment period
|
Safety assessed by physical exam: height
Time Frame: Up to Day 15 of each treatment period
|
For Part 1 and Part 2
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Up to Day 15 of each treatment period
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Safety assessed by physical exam: body mass index (BMI)
Time Frame: Up to Day 15 of each treatment period
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For Part 1 and Part 2
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Up to Day 15 of each treatment period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics of ASP2151 in plasma: AUC0-inf
Time Frame: Up to 48 hours in each treatment period
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For Part 1 and 2. AUC0-inf: Area under the concentration time curve from the time of dosing extrapolated to time infinity
|
Up to 48 hours in each treatment period
|
Pharmacokinetics of ASP2151 in plasma: t1/2
Time Frame: Up to 48 hours in each treatment period
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For Part 1 and 2. t1/2: Apparent terminal elimination half-life
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Up to 48 hours in each treatment period
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Pharmacokinetics of ASP2151 in plasma: Cmax
Time Frame: Up to 48 hours in each treatment period
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For Part 1 and 2. Cmax: Maximum concentration
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Up to 48 hours in each treatment period
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Pharmacokinetics of ASP2151 in plasma: tmax
Time Frame: Up to 48 hours in each treatment period
|
For Part 1 and 2. tmax: The time after dosing when Cmax occurs
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Up to 48 hours in each treatment period
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Pharmacokinetics of ASP2151 in plasma: CL/F
Time Frame: Up to 48 hours in each treatment period
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For Part 1 and 2. CL/F: Oral clearance
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Up to 48 hours in each treatment period
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Pharmacokinetics of ASP2151 in plasma: Vz/F
Time Frame: Up to 48 hours in each treatment period
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For Part 1 and 2. Vz/F: Apparent volume of distribution
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Up to 48 hours in each treatment period
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Pharmacokinetics of ASP2151 in plasma: AUClast
Time Frame: Up to 48 hours in each treatment period
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For Part 1 and 2. AUClast: Area under the plasma concentration time curve from time of dosing up to the last quantifiable sample
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Up to 48 hours in each treatment period
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Pharmacokinetics of ASP2151 in plasma: tlag
Time Frame: Up to 48 hours in each treatment period
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For Part 1 and 2. tlag: Absorption lag time
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Up to 48 hours in each treatment period
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Pharmacokinetics of ASP2151 in urine: Aelast
Time Frame: 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
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Up to 48 hours in each treatment period
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Pharmacokinetics of ASP2151 in urine: Ae0-inf
Time Frame: 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
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Up to 48 hours in each treatment period
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Pharmacokinetics of ASP2151 in urine: Ae%
Time Frame: Up to 48 hours in each treatment period
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For Part 1 and 2. Ae%: Percent of ASP2151 amount excreted in urine
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Up to 48 hours in each treatment period
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Pharmacokinetics of ASP2151 in urine: CLr
Time Frame: Up to 48 hours in each treatment period
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For Part 1 and 2. CLr: Renal clearance
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Up to 48 hours in each treatment period
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Medical Director, Astellas Pharma Clinical Pharmacology & Exploratory Dev.
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Virus Diseases
- Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- DNA Virus Infections
- Skin Diseases, Infectious
- Skin Diseases, Viral
- Herpesviridae Infections
- Varicella Zoster Virus Infection
- Herpes Zoster
- Herpes Simplex
- Herpes Genitalis
Other Study ID Numbers
- 15L-CL-002
- 2005-002697-30 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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