Healthy Subjects Clinical Trial
Official title:
A Double Blind, Randomized and Placebo Controlled Ascending Single Oral Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ASP1707 in Healthy Young Japanese Male Subjects
Three groups of 8 Japanese males are given single ascending doses of ASP1707 or placebo to assess the safety and tolerability, and to evaluate how it is absorbed, metabolized and distributed through the body.
Status | Completed |
Enrollment | 24 |
Est. completion date | August 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Born in Japan - Both parents are of Japanese descent - Time residing outside Japan does not exceed 5 years - Maintains Japanese life style including diet - Male subject must be non-fertile, i.e. surgically sterilized or must practice an effective contraceptive method Exclusion Criteria: - Subjects with out-of-range T levels in serum at screening - Subjects with any history of cancer |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United Kingdom | Parexel Early Phase | Harrow |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Europe B.V. |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability measured by Adverse events (AE) | Day -2 to ESV (up to Day 19) | Yes | |
Primary | Safety and tolerability measured by physical examination (PE) | Day -2 to ESV (up to Day 19) | Yes | |
Primary | Safety and tolerability measured by vital signs (VS) | Day -2 to ESV (up to Day 19) | Yes | |
Primary | Safety and tolerability measured by laboratory tests | Day -2 to ESV (up to Day 19) | Yes | |
Primary | Safety and tolerability measured by 12 lead electrocardiogram (ECG) | Day -2 to ESV (up to Day 19) | Yes | |
Secondary | PK profile of single ascending doses of ASP1707 in plasma | area under the plasma concentration - time curve (AUC) extrapolated to time = infinity (AUCinf), AUC from time of dosing until last measurable concentration (AUClast), time to reach quantifiable concentrations (tlag), maximum concentration (Cmax), time to attain Cmax (tmax), terminal elimination half-life (t1/2), apparent volume of distribution (Vz/F), apparent clearance (CL/F) | Days 1 to 5 | No |
Secondary | PK profile of single ascending doses of ASP1707 in urine | amount excreted unchanged into urine (Ae) from time of dosing until last measurable concentration (Aelast), Ae extrapolated to time = infinity (Aeinf), Ae from time of dosing until last measurable concentration as percentage of total dose (Aelast%), Ae extrapolated to time = infinity as percentage of total dose (Aeinf%), renal clearance (CLR) | Days 1 to 5 | No |
Secondary | Pharmacodynamics of Testosterone (T) | measured by minimum concentration (Cmin), time to attain Cmin (tmin), maximal %Reduction T only: number and percentage of subjects with T castration level (= T < 500 pg/mL) after single dose, time of onset and offset of T < 500 pg/mL after single dose, duration of T <500 pg/mL after single dose | Day -1 to ESV | No |
Secondary | Pharmacodynamics of Luteinizing Hormone (LH) | measured by minimum concentration (Cmin), time to attain Cmin (tmin), maximal %Reduction T only: number and percentage of subjects with T castration level (= T < 500 pg/mL) after single dose, time of onset and offset of T < 500 pg/mL after single dose, duration of T <500 pg/mL after single dose | Day -1 to ESV | No |
Secondary | Pharmacodynamics of Follicle-Stimulating Hormone (FSH) levels | measured by minimum concentration (Cmin), time to attain Cmin (tmin), maximal %Reduction T only: number and percentage of subjects with T castration level (= T < 500 pg/mL) after single dose, time of onset and offset of T < 500 pg/mL after single dose, duration of T <500 pg/mL after single dose | Day -1 to ESV | No |
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