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

Herpes Zoster Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02852876
• Other study ID #: 15L-CL-002
• Secondary ID: 2005-002697-30
• Status: Completed
• Phase: Phase 1
• First received: July 29, 2016
• Last updated: July 29, 2016
• Start date: September 2005
• Est. completion date: December 2005

Study information

• Verified date: July 2016
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Herpes Genitalis
• Herpes Zoster

Intervention

Drug:
• ASP2151
Oral
• Placebo
Oral

Locations

Country	Name	City	State
France	Site FR1717	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe Ltd.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Safety assessed by 12- lead electrocardiogram (ECG)	For Part 1 and Part 2	Up to Day 15 of each treatment period	No
Primary	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	No
Primary	Safety assessed by vital sign measurement: pulse rate	For Part 1 and Part 2	Up to Day 15 of each treatment period	No
Primary	Safety assessed by laboratory test: biochemical	For Part 1 and Part 2	Up to Day 15 of each treatment period	No
Primary	Safety assessed by laboratory test: hematological	For Part 1 and Part 2	Up to Day 15 of each treatment period	No
Primary	Safety assessed by laboratory test: serology	For Part 1 and Part 2	Up to Day 15 of each treatment period	No
Primary	Safety assessed by laboratory test: urinalysis	For Part 1 and Part 2	Up to Day 15 of each treatment period	No
Primary	Safety assessed by physical exam: body weight	For Part 1 and Part 2	Up to Day 15 of each treatment period	No
Primary	Safety assessed by physical exam: height	For Part 1 and Part 2	Up to Day 15 of each treatment period	No
Primary	Safety assessed by physical exam: body mass index (BMI)	For Part 1 and Part 2	Up to Day 15 of each treatment period	No
Secondary	Pharmacokinetics of ASP2151 in plasma: AUC0-inf	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	No
Secondary	Pharmacokinetics of ASP2151 in plasma: t1/2	For Part 1 and 2. t1/2: Apparent terminal elimination half-life	Up to 48 hours in each treatment period	No
Secondary	Pharmacokinetics of ASP2151 in plasma: Cmax	For Part 1 and 2. Cmax: Maximum concentration	Up to 48 hours in each treatment period	No
Secondary	Pharmacokinetics of ASP2151 in plasma: tmax	For Part 1 and 2. tmax: The time after dosing when Cmax occurs	Up to 48 hours in each treatment period	No
Secondary	Pharmacokinetics of ASP2151 in plasma: CL/F	For Part 1 and 2. CL/F: Oral clearance	Up to 48 hours in each treatment period	No
Secondary	Pharmacokinetics of ASP2151 in plasma: Vz/F	For Part 1 and 2. Vz/F: Apparent volume of distribution	Up to 48 hours in each treatment period	No
Secondary	Pharmacokinetics of ASP2151 in plasma: AUClast	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	No
Secondary	Pharmacokinetics of ASP2151 in plasma: tlag	For Part 1 and 2. tlag: Absorption lag time	Up to 48 hours in each treatment period	No
Secondary	Pharmacokinetics of ASP2151 in urine: Aelast	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	No
Secondary	Pharmacokinetics of ASP2151 in urine: Ae0-inf	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	No
Secondary	Pharmacokinetics of ASP2151 in urine: Ae%	For Part 1 and 2. Ae%: Percent of ASP2151 amount excreted in urine	Up to 48 hours in each treatment period	No
Secondary	Pharmacokinetics of ASP2151 in urine: CLr	For Part 1 and 2. CLr: Renal clearance	Up to 48 hours in each treatment period	No