Clinical Trials/NCT02852876

NCT02852876

Completed

Phase 1

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

Astellas Pharma Europe Ltd.1 site in 1 country72 target enrollmentSeptember 2005

ConditionsHerpes Genitalis Herpes Zoster

InterventionsASP2151 Placebo

DrugsASP2151 Placebo

Overview

Phase: Phase 1
Intervention: ASP2151
Conditions: Herpes Genitalis
Sponsor: Astellas Pharma Europe Ltd.
Enrollment: 72
Locations: 1
Primary Endpoint: Safety assessed by vital sign measurement: pulse rate
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2005

End Date

December 2005

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Astellas Pharma Europe Ltd.

Responsible Party

Sponsor

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

Arms & Interventions

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

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

Intervention: ASP2151

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

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

Intervention: ASP2151

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

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

Intervention: ASP2151

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

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

Intervention: ASP2151

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

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

Intervention: ASP2151

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

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

Intervention: ASP2151

Part 1: Placebo Single Ascending Dose (Fasting)

Participants will receive single dose of matching placebo on day 1

Intervention: Placebo

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: ASP2151

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: ASP2151

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

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

Intervention: ASP2151

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

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

Intervention: ASP2151