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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02852876
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )

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.


Condition or disease Intervention/treatment Phase
Herpes Genitalis Herpes Zoster Drug: ASP2151 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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 Start Date : September 2005
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine


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
Drug: ASP2151
Oral

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
Oral

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
Oral

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
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
Drug: ASP2151
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
Drug: ASP2151
Oral

Placebo Comparator: Part 1: Placebo Single Ascending Dose (Fasting)
Participants will receive single dose of matching placebo on day 1
Drug: Placebo
Oral

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
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)
Drug: ASP2151
Oral

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
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
Drug: ASP2151
Oral




Primary Outcome Measures :
  1. Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs) [ Time Frame: Up to Day 15 of each treatment period ]
    For Part 1 and Part 2

  2. Safety assessed by 12- lead electrocardiogram (ECG) [ Time Frame: Up to Day 15 of each treatment period ]
    For Part 1 and Part 2

  3. 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

  4. Safety assessed by vital sign measurement: pulse rate [ Time Frame: Up to Day 15 of each treatment period ]
    For Part 1 and Part 2

  5. Safety assessed by laboratory test: biochemical [ Time Frame: Up to Day 15 of each treatment period ]
    For Part 1 and Part 2

  6. Safety assessed by laboratory test: hematological [ Time Frame: Up to Day 15 of each treatment period ]
    For Part 1 and Part 2

  7. Safety assessed by laboratory test: serology [ Time Frame: Up to Day 15 of each treatment period ]
    For Part 1 and Part 2

  8. Safety assessed by laboratory test: urinalysis [ Time Frame: Up to Day 15 of each treatment period ]
    For Part 1 and Part 2

  9. Safety assessed by physical exam: body weight [ Time Frame: Up to Day 15 of each treatment period ]
    For Part 1 and Part 2

  10. Safety assessed by physical exam: height [ Time Frame: Up to Day 15 of each treatment period ]
    For Part 1 and Part 2

  11. Safety assessed by physical exam: body mass index (BMI) [ Time Frame: Up to Day 15 of each treatment period ]
    For Part 1 and Part 2


Secondary Outcome Measures :
  1. Pharmacokinetics of ASP2151 in plasma: AUC0-inf [ Time Frame: 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

  2. Pharmacokinetics of ASP2151 in plasma: t1/2 [ Time Frame: Up to 48 hours in each treatment period ]
    For Part 1 and 2. t1/2: Apparent terminal elimination half-life

  3. Pharmacokinetics of ASP2151 in plasma: Cmax [ Time Frame: Up to 48 hours in each treatment period ]
    For Part 1 and 2. Cmax: Maximum concentration

  4. 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

  5. Pharmacokinetics of ASP2151 in plasma: CL/F [ Time Frame: Up to 48 hours in each treatment period ]
    For Part 1 and 2. CL/F: Oral clearance

  6. Pharmacokinetics of ASP2151 in plasma: Vz/F [ Time Frame: Up to 48 hours in each treatment period ]
    For Part 1 and 2. Vz/F: Apparent volume of distribution

  7. Pharmacokinetics of ASP2151 in plasma: AUClast [ Time Frame: 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

  8. Pharmacokinetics of ASP2151 in plasma: tlag [ Time Frame: Up to 48 hours in each treatment period ]
    For Part 1 and 2. tlag: Absorption lag time

  9. 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

  10. 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

  11. Pharmacokinetics of ASP2151 in urine: Ae% [ Time Frame: Up to 48 hours in each treatment period ]
    For Part 1 and 2. Ae%: Percent of ASP2151 amount excreted in urine

  12. Pharmacokinetics of ASP2151 in urine: CLr [ Time Frame: Up to 48 hours in each treatment period ]
    For Part 1 and 2. CLr: Renal clearance



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852876


Locations
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France
Site FR1717
Paris, France, 75015
Sponsors and Collaborators
Astellas Pharma Europe Ltd.
Investigators
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Study Director: Medical Director Astellas Pharma Clinical Pharmacology & Exploratory Dev.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Astellas Pharma Europe Ltd.
ClinicalTrials.gov Identifier: NCT02852876    
Other Study ID Numbers: 15L-CL-002
2005-002697-30 ( EudraCT Number )
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe Ltd. ):
Safety of ASP2151
Phase 1
Pharmacokinetics
Healthy male subjects
Tolerability
Food effect of ASP2151
Additional relevant MeSH terms:
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Herpes Zoster
Herpes Genitalis
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Herpes Simplex
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female