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

NCT02852876 | Completed Phase 1

• 2 other identifiers: 15L-CL-0022005-002697-30
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Herpes Genitalis; Herpes Zoster

Keywords

Safety of ASP2151; Phase 1; Pharmacokinetics; Healthy male subjects; Tolerability; Food effect of ASP2151

Outcome Measures

Primary Outcomes (11)

• Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs)

  For Part 1 and Part 2

  Up to Day 15 of each treatment period

• Safety assessed by 12- lead electrocardiogram (ECG)

  For Part 1 and Part 2

  Up to Day 15 of each treatment period

• Safety assessed by vital sign measurement: blood pressure

  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

  For Part 1 and Part 2

  Up to Day 15 of each treatment period

• Safety assessed by laboratory test: biochemical

  For Part 1 and Part 2

  Up to Day 15 of each treatment period

• Safety assessed by laboratory test: hematological

  For Part 1 and Part 2

  Up to Day 15 of each treatment period

• Safety assessed by laboratory test: serology

  For Part 1 and Part 2

  Up to Day 15 of each treatment period

• Safety assessed by laboratory test: urinalysis

  For Part 1 and Part 2

  Up to Day 15 of each treatment period

• Safety assessed by physical exam: body weight

  For Part 1 and Part 2

  Up to Day 15 of each treatment period

• Safety assessed by physical exam: height

  For Part 1 and Part 2

  Up to Day 15 of each treatment period

• Safety assessed by physical exam: body mass index (BMI)

  For Part 1 and Part 2

  Up to Day 15 of each treatment period

Secondary Outcomes (12)

• Pharmacokinetics of ASP2151 in plasma: AUC0-inf

  Up to 48 hours in each treatment period

• Pharmacokinetics of ASP2151 in plasma: t1/2

  Up to 48 hours in each treatment period

• Pharmacokinetics of ASP2151 in plasma: Cmax

  Up to 48 hours in each treatment period

• Pharmacokinetics of ASP2151 in plasma: tmax

  Up to 48 hours in each treatment period

• Pharmacokinetics of ASP2151 in plasma: CL/F

  Up to 48 hours in each treatment period

Study Arms (11)

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

EXPERIMENTAL

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

Drug: ASP2151

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

EXPERIMENTAL

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

Drug: ASP2151

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

EXPERIMENTAL

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

Drug: ASP2151

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

EXPERIMENTAL

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

Drug: ASP2151

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

EXPERIMENTAL

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

Drug: ASP2151

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

EXPERIMENTAL

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

Drug: ASP2151

Part 1: Placebo Single Ascending Dose (Fasting)

PLACEBO COMPARATOR

Participants will receive single dose of matching placebo on day 1

Drug: Placebo

Part 2: ASP2151 (Fasting)

EXPERIMENTAL

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

Part 2: ASP2151 (Fed)

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Drug: ASP2151

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

EXPERIMENTAL

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

Drug: ASP2151

Interventions

ASP2151 DRUG

Oral

Part 1: ASP2151 Single Ascending Dose Group A (Fasting); Part 1: ASP2151 Single Ascending Dose Group B (Fasting); Part 1: ASP2151 Single Ascending Dose Group C (Fasting); Part 1: ASP2151 Single Ascending Dose Group D (Fasting); Part 1: ASP2151 Single Ascending Dose Group E (Fasting); Part 1: ASP2151 Single Ascending Dose Group F (Fasting); Part 1: ASP2151 Single Ascending Dose Group G (Fasting); Part 1: ASP2151 Single Ascending Dose Group H (Fasting); Part 2: ASP2151 (Fasting); Part 2: ASP2151 (Fed)

Placebo DRUG

Oral

Part 1: Placebo Single Ascending Dose (Fasting)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body weight between 60 and 100 kg, and BMI between 18 and 30 kg/m2 inclusive

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Europe Ltd.: lead

Study Sites (1)

Site FR1717

Paris, 75015, France

Location

Related Publications (1)

• 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.

  PMID: 29134426 DERIVED

MeSH Terms

Conditions

Herpes Genitalis; Herpes Zoster

Interventions

ASP2151

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Varicella Zoster Virus Infection

Study Officials

• Medical Director

  Astellas Pharma Clinical Pharmacology & Exploratory Dev.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 2, 2016
• Study Start: September 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: August 2, 2016

Record last verified: 2016-07

Locations

FR (1)