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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


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
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