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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. )

Tracking Information
First Submitted Date  ICMJE July 29, 2016
First Posted Date  ICMJE August 2, 2016
Last Update Posted Date August 2, 2016
Study Start Date  ICMJE September 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2016)
  • 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
  • Safety assessed by 12- lead electrocardiogram (ECG) [ Time Frame: Up to Day 15 of each treatment period ]
    For Part 1 and Part 2
  • 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
  • Safety assessed by vital sign measurement: pulse rate [ Time Frame: Up to Day 15 of each treatment period ]
    For Part 1 and Part 2
  • Safety assessed by laboratory test: biochemical [ Time Frame: Up to Day 15 of each treatment period ]
    For Part 1 and Part 2
  • Safety assessed by laboratory test: hematological [ Time Frame: Up to Day 15 of each treatment period ]
    For Part 1 and Part 2
  • Safety assessed by laboratory test: serology [ Time Frame: Up to Day 15 of each treatment period ]
    For Part 1 and Part 2
  • Safety assessed by laboratory test: urinalysis [ Time Frame: Up to Day 15 of each treatment period ]
    For Part 1 and Part 2
  • Safety assessed by physical exam: body weight [ Time Frame: Up to Day 15 of each treatment period ]
    For Part 1 and Part 2
  • Safety assessed by physical exam: height [ Time Frame: Up to Day 15 of each treatment period ]
    For Part 1 and Part 2
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2016)
  • 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
  • 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
  • Pharmacokinetics of ASP2151 in plasma: Cmax [ Time Frame: Up to 48 hours in each treatment period ]
    For Part 1 and 2. Cmax: Maximum concentration
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Pharmacokinetics of ASP2151 in urine: CLr [ Time Frame: Up to 48 hours in each treatment period ]
    For Part 1 and 2. CLr: Renal clearance
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Pharmacokinetics of Single Doses of ASP2151 in Healthy Male Subjects and the Effects of Food
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Herpes Genitalis
  • Herpes Zoster
Intervention  ICMJE
  • Drug: ASP2151
    Oral
  • Drug: Placebo
    Oral
Study Arms  ICMJE
  • Experimental: Part 1: ASP2151 Single Ascending Dose Group A (Fasting)
    Participants will receive single dose of ASP2151 assigned to Group A on day 1
    Intervention: 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
    Intervention: 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
    Intervention: 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
    Intervention: 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
    Intervention: 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
    Intervention: Drug: ASP2151
  • Placebo Comparator: Part 1: Placebo Single Ascending Dose (Fasting)
    Participants will receive single dose of matching placebo on day 1
    Intervention: 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)
    Intervention: 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)
    Intervention: 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
    Intervention: 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
    Intervention: Drug: ASP2151
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2016)
72
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02852876
Other Study ID Numbers  ICMJE 15L-CL-002
2005-002697-30 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
Study Sponsor  ICMJE Astellas Pharma Europe Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Astellas Pharma Clinical Pharmacology & Exploratory Dev.
PRS Account Astellas Pharma Inc
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP