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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Placebo; Drug: ASP1707

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Harrow, United Kingdom, HA1 3UJ
    • Parexel Early Phase

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1. ASP1707 lowest dose	Drug: Placebo; oral; Drug: ASP1707; oral
Experimental: 2 ASP1707 higher dose	Drug: Placebo; oral; Drug: ASP1707; oral
Experimental: 3. ASP1707 Highest dose	Drug: Placebo; oral; Drug: ASP1707; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Astellas Pharma Europe B.V.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: April 4, 2014
• First Submitted That Met QC Criteria: May 21, 2014
• First Posted (Estimate): May 26, 2014

Study Record Updates

• Last Update Posted (Estimate): May 26, 2014
• Last Update Submitted That Met QC Criteria: May 21, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Pharmacodynamics; Japanese subjects; ASP1707
• Other Study ID Numbers: 1707-CL-0002; 2010-024040-15 (EudraCT Number)