Healthy SubjectsPhase 1NCT02146742
A Study to Assess the Effects of Single Ascending Doses of ASP1707 in Healthy Young Japanese Male Subjects
A Phase 1 study testing ASP1707 in people with Healthy Subjects, run by Astellas Pharma Europe B.V. at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- ASP1707
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2011to Aug 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Subjects with out-of-range T levels in serum at screening
- Subjects with any history of cancer
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy Subjects
- Being tested
- ASP1707, Placebo
- Keywords
- ASP1707, Japanese subjects, Safety, Pharmacokinetics, Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP1707Drug
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| 1. ASP1707 lowest dose | Experimental | Not described Receives: Drug: ASP1707; Drug: Placebo |
| 2 ASP1707 higher dose | Experimental | Not described Receives: Drug: ASP1707; Drug: Placebo |
| 3. ASP1707 Highest dose | Experimental | Not described Receives: Drug: ASP1707; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability measured by Adverse events (AE)
Measured: Day -2 to ESV (up to Day 19)
Safety and tolerability measured by physical examination (PE)
Measured: Day -2 to ESV (up to Day 19)
Safety and tolerability measured by vital signs (VS)
Measured: Day -2 to ESV (up to Day 19)
Safety and tolerability measured by laboratory tests
Measured: Day -2 to ESV (up to Day 19)
Safety and tolerability measured by 12 lead electrocardiogram (ECG)
Measured: Day -2 to ESV (up to Day 19)
Secondary outcomes (5)
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Day -1 to ESV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startJun 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Manager, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146742
- Sponsor's protocol ID
- 1707-CL-0002
- Other IDs
- 2010-024040-15
- Status last verified
- May 2014
- First submitted
- 4 Apr 2014
- Last updated
- 26 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02146742
- Acronym / sponsor ID
- 1707-CL-0002
- Conditions
- Healthy Subjects
- Keywords
- ASP1707, Japanese subjects, Safety, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 26 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. ASP1707 lowest dose | Experimental | Drug: ASP1707, Drug: Placebo |
| 2 ASP1707 higher dose | Experimental | Drug: ASP1707, Drug: Placebo |
| 3. ASP1707 Highest dose | Experimental | Drug: ASP1707, Drug: Placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Subjects with out-of-range T levels in serum at screening
- Subjects with any history of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP1707oral | Drug | 1. ASP1707 lowest dose, 2 ASP1707 higher dose, 3. ASP1707 Highest dose |
| Placebooral | Drug | 1. ASP1707 lowest dose, 2 ASP1707 higher dose, 3. ASP1707 Highest dose |
Primary outcome
Safety and tolerability measured by Adverse events (AE)
Time frame: Day -2 to ESV (up to Day 19)
Safety and tolerability measured by physical examination (PE)
Time frame: Day -2 to ESV (up to Day 19)
Safety and tolerability measured by vital signs (VS)
Time frame: Day -2 to ESV (up to Day 19)
Safety and tolerability measured by laboratory tests
Time frame: Day -2 to ESV (up to Day 19)
Safety and tolerability measured by 12 lead electrocardiogram (ECG)
Time frame: Day -2 to ESV (up to Day 19)
5 secondary outcomes
PK profile of single ascending doses of ASP1707 in plasma
Time frame: Days 1 to 5
PK profile of single ascending doses of ASP1707 in urine
Time frame: Days 1 to 5
Pharmacodynamics of Testosterone (T)
Time frame: Day -1 to ESV
Pharmacodynamics of Luteinizing Hormone (LH)
Time frame: Day -1 to ESV
Pharmacodynamics of Follicle-Stimulating Hormone (FSH) levels
Time frame: Day -1 to ESV
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Study Manager study chair
Astellas Pharma Europe B.V.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASP1707 in people with Healthy Subjects, run by Astellas Pharma Europe B.V. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability measured by Adverse events (AE) (time frame: Day -2 to ESV (up to Day 19)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2014.