Clinical trial NCT02146742: A Study to Assess the Effects of Single Ascending Doses of ASP1707 in Healthy Young Japanese Male Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: ASP1707
Japanese subjects
Safety
Pharmacokinetics
Pharmacodynamics
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-05-26
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability measured by Adverse events (AE)
timeFrame: Day -2 to ESV (up to Day 19)
measure: Safety and tolerability measured by physical examination (PE)
timeFrame: Day -2 to ESV (up to Day 19)
measure: Safety and tolerability measured by vital signs (VS)
timeFrame: Day -2 to ESV (up to Day 19)
measure: Safety and tolerability measured by laboratory tests
timeFrame: Day -2 to ESV (up to Day 19)
measure: Safety and tolerability measured by 12 lead electrocardiogram (ECG)
timeFrame: Day -2 to ESV (up to Day 19)
Secondary outcomes:
measure: PK profile of single ascending doses of ASP1707 in plasma
timeFrame: Days 1 to 5
measure: PK profile of single ascending doses of ASP1707 in urine
timeFrame: Days 1 to 5
measure: Pharmacodynamics of Testosterone (T)
timeFrame: Day -1 to ESV
measure: Pharmacodynamics of Luteinizing Hormone (LH)
timeFrame: Day -1 to ESV
measure: Pharmacodynamics of Follicle-Stimulating Hormone (FSH) levels
timeFrame: Day -1 to ESV
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: Parexel Early Phase
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Clinical Study Manager
role: STUDY_CHAIR
References: