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CompletedNCT02852876Updated Aug 2, 2016

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

A Phase 1 interventional study of ASP2151 and Placebo in Herpes Genitalis and Herpes Zoster, sponsored by Astellas Pharma Europe Ltd.. Completed at 1 site in France. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-02.

Sponsored by Astellas Pharma Europe Ltd. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Herpes Genitalis
  • Herpes Zoster

Keywords

  • Safety of ASP2151
  • Phase 1
  • Pharmacokinetics
  • Healthy male subjects
  • Tolerability
  • Food effect of ASP2151
03

In context

Herpes Simplex

305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.

This study's enrollment of 72 is below the median of 101 across 227 interventional studies indexed under Herpes Simplex.

Browse Herpes Simplex studies →

Lead sponsor

Astellas Pharma Europe Ltd. is the lead sponsor of 30 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Body weight between 60 and 100 kg, and BMI between 18 and 30 kg/m2 inclusive

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
72 participants (actual)

Study arms

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

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

    Drug: ASP2151

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

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

    Drug: ASP2151

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

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

    Drug: ASP2151

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

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

    Drug: ASP2151

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

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

    Drug: ASP2151

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

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

    Drug: ASP2151

  • Placebo comparator
    Part 1: Placebo Single Ascending Dose (Fasting)

    Participants will receive single dose of matching placebo on day 1

    Drug: Placebo

  • 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)

    Drug: ASP2151

  • 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)

    Drug: ASP2151

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

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

    Drug: ASP2151

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

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

    Drug: ASP2151

Interventions

  • DrugASP2151

    Oral

  • DrugPlacebo

    Oral

06

What researchers measure

Primary outcomes

  1. 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

  2. Safety assessed by 12- lead electrocardiogram (ECG)

    For Part 1 and Part 2

    Time frame: Up to Day 15 of each treatment period

  3. 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

  4. Safety assessed by vital sign measurement: pulse rate

    For Part 1 and Part 2

    Time frame: Up to Day 15 of each treatment period

  5. Safety assessed by laboratory test: biochemical

    For Part 1 and Part 2

    Time frame: Up to Day 15 of each treatment period

  6. Safety assessed by laboratory test: hematological

    For Part 1 and Part 2

    Time frame: Up to Day 15 of each treatment period

  7. Safety assessed by laboratory test: serology

    For Part 1 and Part 2

    Time frame: Up to Day 15 of each treatment period

  8. Safety assessed by laboratory test: urinalysis

    For Part 1 and Part 2

    Time frame: Up to Day 15 of each treatment period

  9. Safety assessed by physical exam: body weight

    For Part 1 and Part 2

    Time frame: Up to Day 15 of each treatment period

  10. Safety assessed by physical exam: height

    For Part 1 and Part 2

    Time frame: Up to Day 15 of each treatment period

  11. Safety assessed by physical exam: body mass index (BMI)

    For Part 1 and Part 2

    Time frame: Up to Day 15 of each treatment period

Secondary outcomes

  1. 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

    Time frame: Up to 48 hours in each treatment period

  2. Pharmacokinetics of ASP2151 in plasma: t1/2

    For Part 1 and 2. t1/2: Apparent terminal elimination half-life

    Time frame: Up to 48 hours in each treatment period

  3. Pharmacokinetics of ASP2151 in plasma: Cmax

    For Part 1 and 2. Cmax: Maximum concentration

    Time frame: Up to 48 hours in each treatment period

  4. Pharmacokinetics of ASP2151 in plasma: tmax

    For Part 1 and 2. tmax: The time after dosing when Cmax occurs

    Time frame: Up to 48 hours in each treatment period

  5. Pharmacokinetics of ASP2151 in plasma: CL/F

    For Part 1 and 2. CL/F: Oral clearance

    Time frame: Up to 48 hours in each treatment period

  6. Pharmacokinetics of ASP2151 in plasma: Vz/F

    For Part 1 and 2. Vz/F: Apparent volume of distribution

    Time frame: Up to 48 hours in each treatment period

  7. 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

    Time frame: Up to 48 hours in each treatment period

  8. Pharmacokinetics of ASP2151 in plasma: tlag

    For Part 1 and 2. tlag: Absorption lag time

    Time frame: Up to 48 hours in each treatment period

  9. 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

    Time frame: Up to 48 hours in each treatment period

  10. 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

    Time frame: Up to 48 hours in each treatment period

  11. Pharmacokinetics of ASP2151 in urine: Ae%

    For Part 1 and 2. Ae%: Percent of ASP2151 amount excreted in urine

    Time frame: Up to 48 hours in each treatment period

  12. Pharmacokinetics of ASP2151 in urine: CLr

    For Part 1 and 2. CLr: Renal clearance

    Time frame: Up to 48 hours in each treatment period

07

Study locations

1 site
  • Site FR1717
    Paris, 75015, France
08

References and documents

Publications

  • 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. PubMed 29134426 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02852876
Lead sponsor
Astellas Pharma Europe Ltd.
Responsible party
Sponsor
First posted
Aug 2, 2016
Start date
Sep 2005
Primary completion
Dec 2005
Completion
Dec 2005
Last update
Aug 2, 2016

Study contacts

Medical Director
study director · Astellas Pharma Clinical Pharmacology & Exploratory Dev.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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