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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02146742
• Other study ID #: 1707-CL-0002
• Secondary ID: 2010-024040-15
• Status: Completed
• Phase: Phase 1
• First received: April 4, 2014
• Last updated: May 21, 2014
• Start date: June 2011
• Est. completion date: August 2011

Study information

• Verified date: May 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• ASP1707
oral
• Placebo
oral

Locations

Country	Name	City	State
United Kingdom	Parexel Early Phase	Harrow

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe B.V.

Country where clinical trial is conducted

United Kingdom, 

Outcome

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