A Study to Assess the Effects of Single Ascending Doses of ASP1707 in Healthy Young Japanese Male Subjects

Study Overview
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Brief Summary
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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.

Detailed Description
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The first group receives the lowest dose while the last group receives the highest dose. ASP1707 or matching placebo is administered as a single dose under fasted conditions. Screening takes place from Day -22 to Day -2. Subjects are admitted to the clinic on Day -1 and remain until Day 5. An end of study visit (ESV) takes place 7-14 days after discharge. Escalation to the next higher dose takes place after review of the safety and tolerability data from the previous dose. Safety assessments are performed throughout the study. Plasma and urine samples are collected for pharmacokinetics (PK) analysis. Serum samples are collected for pharmacodynamic (PD) analysis.

Official Title
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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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: ASP1707
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. ASP1707 lowest dose<br> | Drug: ASP1707<br>* oral<br>Drug: Placebo<br>* oral<br>|
| Experimental: 2 ASP1707 higher dose<br> | Drug: ASP1707<br>* oral<br>Drug: Placebo<br>* oral<br>|
| Experimental: 3. ASP1707 Highest dose<br> | Drug: ASP1707<br>* oral<br>Drug: Placebo<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability measured by Adverse events (AE) |  | Day -2 to ESV (up to Day 19) | 
| Safety and tolerability measured by physical examination (PE) |  | Day -2 to ESV (up to Day 19) | 
| Safety and tolerability measured by vital signs (VS) |  | Day -2 to ESV (up to Day 19) | 
| Safety and tolerability measured by laboratory tests |  | Day -2 to ESV (up to Day 19) | 
| Safety and tolerability measured by 12 lead electrocardiogram (ECG) |  | Day -2 to ESV (up to Day 19) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASP1707, Japanese subjects, Safety, Pharmacokinetics, Pharmacodynamics