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

July 29, 2016 updated by: Astellas Pharma Europe Ltd.

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

Completed

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

Interventional

Enrollment (Actual)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 75015
        • Site FR1717

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
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
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
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
Oral
Placebo Comparator: Part 1: Placebo Single Ascending Dose (Fasting)
Participants will receive single dose of matching placebo on day 1
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)
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)
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
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
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
For Part 1 and Part 2
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
For Part 1 and Part 2
Up to Day 15 of each treatment period
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
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
For Part 1 and Part 2
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
Up to Day 15 of each treatment period
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
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
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
Up to Day 15 of each treatment period
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
Up to Day 15 of each treatment period

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
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
For Part 1 and 2. t1/2: Apparent terminal elimination half-life
Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in plasma: Cmax
Time Frame: Up to 48 hours in each treatment period
For Part 1 and 2. Cmax: Maximum concentration
Up to 48 hours in each treatment period
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
Up to 48 hours in each treatment period
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
Up to 48 hours in each treatment period
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
Up to 48 hours in each treatment period
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
Up to 48 hours in each treatment period
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
Up to 48 hours in each treatment period
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
Up to 48 hours in each treatment period
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
Up to 48 hours in each treatment period
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
Up to 48 hours in each treatment period
Pharmacokinetics of ASP2151 in urine: CLr
Time Frame: Up to 48 hours in each treatment period
For Part 1 and 2. CLr: Renal clearance
Up to 48 hours in each treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Medical Director, Astellas Pharma Clinical Pharmacology & Exploratory Dev.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

July 29, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (Estimate)

August 2, 2016

Study Record Updates

Last Update Posted (Estimate)

August 2, 2016

Last Update Submitted That Met QC Criteria

July 29, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Herpes Zoster

Clinical Trials on Placebo

Subscribe