search
Back to results

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

Primary Purpose

Herpes Genitalis, Herpes Zoster

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
ASP2151
Placebo
Sponsored by
Astellas Pharma Europe Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Herpes Genitalis focused on measuring Safety of ASP2151, Phase 1, Pharmacokinetics, Healthy male subjects, Tolerability, Food effect of ASP2151

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Site FR1717

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Part 1: ASP2151 Single Ascending Dose Group A (Fasting)

Part 1: ASP2151 Single Ascending Dose Group B (Fasting)

Part 1: ASP2151 Single Ascending Dose Group C (Fasting)

Part 1: ASP2151 Single Ascending Dose Group D (Fasting)

Part 1: ASP2151 Single Ascending Dose Group E (Fasting)

Part 1: ASP2151 Single Ascending Dose Group F (Fasting)

Part 1: Placebo Single Ascending Dose (Fasting)

Part 2: ASP2151 (Fasting)

Part 2: ASP2151 (Fed)

Part 1: ASP2151 Single Ascending Dose Group G (Fasting)

Part 1: ASP2151 Single Ascending Dose Group H (Fasting)

Arm Description

Participants will receive single dose of ASP2151 assigned to Group A on day 1

Participants will receive single dose of ASP2151 assigned to Group B on day 1

Participants will receive single dose of ASP2151 assigned to Group C on day 1

Participants will receive single dose of ASP2151 assigned to Group D on day 1

Participants will receive single dose of ASP2151 assigned to Group E on day 1

Participants will receive single dose of ASP2151 assigned to Group F on day 1

Participants will receive single dose of matching placebo on day 1

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)

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)

Participants will receive single dose of ASP2151 assigned to Group G on day 1

Participants will receive single dose of ASP2151 assigned to Group H on day 1

Outcomes

Primary Outcome Measures

Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs)
For Part 1 and Part 2
Safety assessed by 12- lead electrocardiogram (ECG)
For Part 1 and Part 2
Safety assessed by vital sign measurement: blood pressure
For Part 1 and Part 2 includes systolic and blood diastolic pressure
Safety assessed by vital sign measurement: pulse rate
For Part 1 and Part 2
Safety assessed by laboratory test: biochemical
For Part 1 and Part 2
Safety assessed by laboratory test: hematological
For Part 1 and Part 2
Safety assessed by laboratory test: serology
For Part 1 and Part 2
Safety assessed by laboratory test: urinalysis
For Part 1 and Part 2
Safety assessed by physical exam: body weight
For Part 1 and Part 2
Safety assessed by physical exam: height
For Part 1 and Part 2
Safety assessed by physical exam: body mass index (BMI)
For Part 1 and Part 2

Secondary Outcome Measures

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
Pharmacokinetics of ASP2151 in plasma: t1/2
For Part 1 and 2. t1/2: Apparent terminal elimination half-life
Pharmacokinetics of ASP2151 in plasma: Cmax
For Part 1 and 2. Cmax: Maximum concentration
Pharmacokinetics of ASP2151 in plasma: tmax
For Part 1 and 2. tmax: The time after dosing when Cmax occurs
Pharmacokinetics of ASP2151 in plasma: CL/F
For Part 1 and 2. CL/F: Oral clearance
Pharmacokinetics of ASP2151 in plasma: Vz/F
For Part 1 and 2. Vz/F: Apparent volume of distribution
Pharmacokinetics of ASP2151 in plasma: AUClast
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
For Part 1 and 2. tlag: Absorption lag time
Pharmacokinetics of ASP2151 in urine: Aelast
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
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%
For Part 1 and 2. Ae%: Percent of ASP2151 amount excreted in urine
Pharmacokinetics of ASP2151 in urine: CLr
For Part 1 and 2. CLr: Renal clearance

Full Information

First Posted
July 29, 2016
Last Updated
July 29, 2016
Sponsor
Astellas Pharma Europe Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT02852876
Brief Title
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

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Europe Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Genitalis, Herpes Zoster
Keywords
Safety of ASP2151, Phase 1, Pharmacokinetics, Healthy male subjects, Tolerability, Food effect of ASP2151

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1: ASP2151 Single Ascending Dose Group A (Fasting)
Arm Type
Experimental
Arm Description
Participants will receive single dose of ASP2151 assigned to Group A on day 1
Arm Title
Part 1: ASP2151 Single Ascending Dose Group B (Fasting)
Arm Type
Experimental
Arm Description
Participants will receive single dose of ASP2151 assigned to Group B on day 1
Arm Title
Part 1: ASP2151 Single Ascending Dose Group C (Fasting)
Arm Type
Experimental
Arm Description
Participants will receive single dose of ASP2151 assigned to Group C on day 1
Arm Title
Part 1: ASP2151 Single Ascending Dose Group D (Fasting)
Arm Type
Experimental
Arm Description
Participants will receive single dose of ASP2151 assigned to Group D on day 1
Arm Title
Part 1: ASP2151 Single Ascending Dose Group E (Fasting)
Arm Type
Experimental
Arm Description
Participants will receive single dose of ASP2151 assigned to Group E on day 1
Arm Title
Part 1: ASP2151 Single Ascending Dose Group F (Fasting)
Arm Type
Experimental
Arm Description
Participants will receive single dose of ASP2151 assigned to Group F on day 1
Arm Title
Part 1: Placebo Single Ascending Dose (Fasting)
Arm Type
Placebo Comparator
Arm Description
Participants will receive single dose of matching placebo on day 1
Arm Title
Part 2: ASP2151 (Fasting)
Arm Type
Experimental
Arm Description
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)
Arm Title
Part 2: ASP2151 (Fed)
Arm Type
Experimental
Arm Description
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)
Arm Title
Part 1: ASP2151 Single Ascending Dose Group G (Fasting)
Arm Type
Experimental
Arm Description
Participants will receive single dose of ASP2151 assigned to Group G on day 1
Arm Title
Part 1: ASP2151 Single Ascending Dose Group H (Fasting)
Arm Type
Experimental
Arm Description
Participants will receive single dose of ASP2151 assigned to Group H on day 1
Intervention Type
Drug
Intervention Name(s)
ASP2151
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs)
Description
For Part 1 and Part 2
Time Frame
Up to Day 15 of each treatment period
Title
Safety assessed by 12- lead electrocardiogram (ECG)
Description
For Part 1 and Part 2
Time Frame
Up to Day 15 of each treatment period
Title
Safety assessed by vital sign measurement: blood pressure
Description
For Part 1 and Part 2 includes systolic and blood diastolic pressure
Time Frame
Up to Day 15 of each treatment period
Title
Safety assessed by vital sign measurement: pulse rate
Description
For Part 1 and Part 2
Time Frame
Up to Day 15 of each treatment period
Title
Safety assessed by laboratory test: biochemical
Description
For Part 1 and Part 2
Time Frame
Up to Day 15 of each treatment period
Title
Safety assessed by laboratory test: hematological
Description
For Part 1 and Part 2
Time Frame
Up to Day 15 of each treatment period
Title
Safety assessed by laboratory test: serology
Description
For Part 1 and Part 2
Time Frame
Up to Day 15 of each treatment period
Title
Safety assessed by laboratory test: urinalysis
Description
For Part 1 and Part 2
Time Frame
Up to Day 15 of each treatment period
Title
Safety assessed by physical exam: body weight
Description
For Part 1 and Part 2
Time Frame
Up to Day 15 of each treatment period
Title
Safety assessed by physical exam: height
Description
For Part 1 and Part 2
Time Frame
Up to Day 15 of each treatment period
Title
Safety assessed by physical exam: body mass index (BMI)
Description
For Part 1 and Part 2
Time Frame
Up to Day 15 of each treatment period
Secondary Outcome Measure Information:
Title
Pharmacokinetics of ASP2151 in plasma: AUC0-inf
Description
For Part 1 and 2. AUC0-inf: Area under the concentration time curve from the time of dosing extrapolated to time infinity
Time Frame
Up to 48 hours in each treatment period
Title
Pharmacokinetics of ASP2151 in plasma: t1/2
Description
For Part 1 and 2. t1/2: Apparent terminal elimination half-life
Time Frame
Up to 48 hours in each treatment period
Title
Pharmacokinetics of ASP2151 in plasma: Cmax
Description
For Part 1 and 2. Cmax: Maximum concentration
Time Frame
Up to 48 hours in each treatment period
Title
Pharmacokinetics of ASP2151 in plasma: tmax
Description
For Part 1 and 2. tmax: The time after dosing when Cmax occurs
Time Frame
Up to 48 hours in each treatment period
Title
Pharmacokinetics of ASP2151 in plasma: CL/F
Description
For Part 1 and 2. CL/F: Oral clearance
Time Frame
Up to 48 hours in each treatment period
Title
Pharmacokinetics of ASP2151 in plasma: Vz/F
Description
For Part 1 and 2. Vz/F: Apparent volume of distribution
Time Frame
Up to 48 hours in each treatment period
Title
Pharmacokinetics of ASP2151 in plasma: AUClast
Description
For Part 1 and 2. AUClast: Area under the plasma concentration time curve from time of dosing up to the last quantifiable sample
Time Frame
Up to 48 hours in each treatment period
Title
Pharmacokinetics of ASP2151 in plasma: tlag
Description
For Part 1 and 2. tlag: Absorption lag time
Time Frame
Up to 48 hours in each treatment period
Title
Pharmacokinetics of ASP2151 in urine: Aelast
Description
For Part 1 and 2. Aelast: Amount excreted unchanged in urine from time of dosing up to the last quantifiable sample
Time Frame
Up to 48 hours in each treatment period
Title
Pharmacokinetics of ASP2151 in urine: Ae0-inf
Description
For Part 1 and 2. Ae0-inf: Amount excreted unchanged in urine from time of dosing extrapolated to infinity
Time Frame
Up to 48 hours in each treatment period
Title
Pharmacokinetics of ASP2151 in urine: Ae%
Description
For Part 1 and 2. Ae%: Percent of ASP2151 amount excreted in urine
Time Frame
Up to 48 hours in each treatment period
Title
Pharmacokinetics of ASP2151 in urine: CLr
Description
For Part 1 and 2. CLr: Renal clearance
Time Frame
Up to 48 hours in each treatment period

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Clinical Pharmacology & Exploratory Dev.
Official's Role
Study Director
Facility Information:
Facility Name
Site FR1717
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29134426
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs