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

NCT ID: NCT02852876

Last Updated: 2016-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2005-12-31

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.

Conditions

Herpes Genitalis; Herpes Zoster

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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

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

Group Type: EXPERIMENTAL

ASP2151

Intervention Type: DRUG

Oral

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

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

Group Type: EXPERIMENTAL

ASP2151

Intervention Type: DRUG

Oral

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

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

Group Type: EXPERIMENTAL

ASP2151

Intervention Type: DRUG

Oral

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

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

Group Type: EXPERIMENTAL

ASP2151

Intervention Type: DRUG

Oral

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

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

Group Type: EXPERIMENTAL

ASP2151

Intervention Type: DRUG

Oral

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

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

Group Type: EXPERIMENTAL

ASP2151

Intervention Type: DRUG

Oral

Part 1: Placebo Single Ascending Dose (Fasting)

Participants will receive single dose of matching placebo on day 1

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral

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)

Group Type: EXPERIMENTAL

ASP2151

Intervention Type: DRUG

Oral

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)

Group Type: EXPERIMENTAL

ASP2151

Intervention Type: DRUG

Oral

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

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

Group Type: EXPERIMENTAL

ASP2151

Intervention Type: DRUG

Oral

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

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

Group Type: EXPERIMENTAL

ASP2151

Intervention Type: DRUG

Oral

Interventions

ASP2151

Oral

Intervention Type: DRUG

Placebo

Oral

Intervention Type: DRUG

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Astellas Pharma Europe Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Clinical Pharmacology & Exploratory Dev.

Locations

Site FR1717

Paris, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 29134426 (View on PubMed)

Other Identifiers

2005-002697-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15L-CL-002

Identifier Type: -

Identifier Source: org_study_id