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
2 other identifiers
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 4, 2014
CompletedFirst Posted
Study publicly available on registry
May 26, 2014
CompletedMay 26, 2014
May 1, 2014
2 months
April 4, 2014
May 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (5)
PK profile of single ascending doses of ASP1707 in plasma
Days 1 to 5
PK profile of single ascending doses of ASP1707 in urine
Days 1 to 5
Pharmacodynamics of Testosterone (T)
Day -1 to ESV
Pharmacodynamics of Luteinizing Hormone (LH)
Day -1 to ESV
Pharmacodynamics of Follicle-Stimulating Hormone (FSH) levels
Day -1 to ESV
Study Arms (3)
1. ASP1707 lowest dose
EXPERIMENTAL2 ASP1707 higher dose
EXPERIMENTAL3. ASP1707 Highest dose
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Subjects with out-of-range T levels in serum at screening
- Subjects with any history of cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Parexel Early Phase
Harrow, HA1 3UJ, United Kingdom
MeSH Terms
Interventions
Study Officials
- STUDY CHAIR
Clinical Study Manager
Astellas Pharma Europe B.V.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2014
First Posted
May 26, 2014
Study Start
June 1, 2011
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
May 26, 2014
Record last verified: 2014-05