Healthy SubjectsPhase 1NCT02046798
A Study to Assess the Pharmacokinetics, Metabolism and Excretion Routes of ASP3652 in Man, After Administration of 14C Radio Labeled ASP3652
A Phase 1 study testing ASP3652 in people with Healthy Subjects and Pharmacokinetics of ASP3652, run by Astellas Pharma Europe B.V. at 1 site in United Kingdom.
Trial summary
This study measures how much of the trial drug enters the body and how long it takes for the body to remove it via the feces and urine. In addition, the different breakdown products after a single oral dose of radio-active ASP3652 will be identified. Read more about this study
- Who is it for?
- Ages 35 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Pharmacokinetics of ASP3652
- What is being tested?
- ASP3652
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2012to Aug 2012
- 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 35 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is white and of Caucasian origin.
- Regular defecation pattern (minimum once per day).
- Subject must agree to use a condom during sexual intercourse until 3 months after dosing. In addition to using a condom, subjects must agree to practice an adequate contraceptive method with female sexual partners to prevent pregnancy.
Who cannot join
- Known or suspected hypersensitivity to ASP3652 or any components of the formulation used.
- Donation of blood or blood products within 3 months prior to admission to the Clinical Unit.
- Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton (excluding spinal column)), during work or during participation in a clinical study in the previous year.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Covance Clinical Research Unit (CRU) Ltd.
Leeds, LS2 9LH
About this study
Official title: An Open Label Study to Evaluate the Pharmacokinetics of ASP3652 After a Single Oral Dose of 14C-labeled ASP3652 in Healthy Caucasian Male Subjects
This study measures how much of the trial drug enters the body and how long it takes for the body to remove it via the feces and urine. In addition, the different breakdown products after a single oral dose of radio-active ASP3652 will be identified.
Read the detailed description
This is an open-label, one-period, single-dose study with 14C labeled ASP3652.
Screening takes place between Day 22 to Day 2, and subjects are admitted to the clinic on Day -1.
On the morning of Day 1, each subject receives a single oral dose of 14C-labeled ASP3652. Blood, urine and feces samples for analysis of 14C radioactivity are collected until at least 120 h after dosing. Blood samples for the analysis of ASP3652 and metabolites are collected until 120 h after dosing.
The subjects remain in the clinic until Day 6 (or up to Day 13 in case discharge criteria are not met on Day 6) and return for an End of Study Visit (ESV) 7 to 14 days after (early) discharge.
- Conditions
- Healthy Subjects, Pharmacokinetics of ASP3652
- Being tested
- ASP3652
- Keywords
- Pharmacokinetics, ASP3652, 14C radio-labeled, Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP3652Drug
oral
| Study group | Role | What they receive |
|---|---|---|
| 14C labeled ASP3652 | Experimental | Not described Receives: Drug: ASP3652 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radioactivity in plasma
area under the plasma concentration (AUC) - time curve from time zero to infinity (AUCinf), area under the plasma concentration - time curve from time zero to time of last measurable concentration (AUClast), maximum concentration (Cmax), time to attain Cmax (tmax), apparent terminal elimination half-life (t½)
Measured: Days 1 to 6 and up to Day 9
Total radioactivity in whole blood
area under the plasma concentration (AUC) - time curve from time zero to infinity (AUCinf), area under the plasma concentration - time curve from time zero to time of last measurable concentration (AUClast), maximum concentration (Cmax), time to attain Cmax (tmax), apparent terminal elimination half-life (t½)
Measured: Days 1 to 6 and up to Day 9
Radioactivity ratio of plasma / blood
ratio concentrations per time point and AUC
Measured: Days 1 to 6 and up to Day 9
Radioactivity excretion in urine
excretion rate and cumulative excretion
Measured: Urine: Days 1-6 and up to Day 25
Radioactivity excretion in feces
excretion rate and cumulative excretion
Measured: Days 1-6 and up to Day 25
Radioactivity excretion in urine and feces
excretion rate and cumulative excretion
Measured: Urine: Days 1-6 and up to Day 25
ASP3652 in plasma
AUCinf, AUClast, Cmax, tmax, t1/2, apparent clearance after oral administration at steady state (CL/F), volume of terminal phase distribution at steady state (Vz/F)
Measured: Days 1 to 6 and up to Day 9
ASP3652 in urine
cumulative amount of unchanged drug excreted into the urine from time zero to infinity after single dose (Aeinf), cumulative amount of unchanged drug excreted into the urine from time zero to time of last measurable concentration (Aelast), renal clearance of the drug from plasma (CLR), percentage of unchanged drug excreted into the urine from time zero to infinity after single dose % of dose excreted (Aeinf%), percentage of unchanged drug excreted into the urine from time zero to time of last measurable concentration (Aelast%)
Measured: Days 1-6 and up to Day 25
Ratio ASP3652 to 14C-radioactivity for AUCinf
area under the plasma concentration (AUC) - time curve from time zero to infinity (AUCinf)
Measured: Days 1 to 6 and up to Day 9
Secondary outcomes (1)
Safety and tolerability after a single dose
Vital signs, 12-lead ECG, safety laboratory tests, physical examination, occurrence of Adverse Events (AE)
Measured: Screening (Day 22 to Day 2) to End of Study Visit (7 to 14 days after (early) discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startJul 2012
- Primary completionAug 2012
- Study completionAug 2012
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046798
- Sponsor's protocol ID
- 3652-CL-0003
- Other IDs
- 2011-004526-10
- Status last verified
- Jan 2014
- First submitted
- 24 Jan 2014
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Evaluate the Pharmacokinetics of ASP3652 After a Single Oral Dose of 14C-labeled ASP3652 in Healthy Caucasian Male Subjects
- ClinicalTrials.gov ID
- NCT02046798
- Acronym / sponsor ID
- 3652-CL-0003
- Conditions
- Healthy Subjects, Pharmacokinetics of ASP3652
- Keywords
- Pharmacokinetics, ASP3652, 14C radio-labeled, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 28 Jan 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.
This study measures how much of the trial drug enters the body and how long it takes for the body to remove it via the feces and urine. In addition, the different breakdown products after a single oral dose of radio-active ASP3652 will be identified.
Detailed description
This is an open-label, one-period, single-dose study with 14C labeled ASP3652.
Screening takes place between Day 22 to Day 2, and subjects are admitted to the clinic on Day -1.
On the morning of Day 1, each subject receives a single oral dose of 14C-labeled ASP3652. Blood, urine and feces samples for analysis of 14C radioactivity are collected until at least 120 h after dosing. Blood samples for the analysis of ASP3652 and metabolites are collected until 120 h after dosing.
The subjects remain in the clinic until Day 6 (or up to Day 13 in case discharge criteria are not met on Day 6) and return for an End of Study Visit (ESV) 7 to 14 days after (early) discharge.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 14C labeled ASP3652 | Experimental | Drug: ASP3652 |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject is white and of Caucasian origin.
- Regular defecation pattern (minimum once per day).
- Subject must agree to use a condom during sexual intercourse until 3 months after dosing. In addition to using a condom, subjects must agree to practice an adequate contraceptive method with female sexual partners to prevent pregnancy.
Key exclusion criteria (3 listed)
- Known or suspected hypersensitivity to ASP3652 or any components of the formulation used.
- Donation of blood or blood products within 3 months prior to admission to the Clinical Unit.
- Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton (excluding spinal column)), during work or during participation in a clinical study in the previous year.
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 |
|---|---|---|
| ASP3652oral | Drug | 14C labeled ASP3652 |
Primary outcome
Total radioactivity in plasma
Time frame: Days 1 to 6 and up to Day 9
area under the plasma concentration (AUC) - time curve from time zero to infinity (AUCinf), area under the plasma concentration - time curve from time zero to time of last measurable concentration (AUClast), maximum concentration (Cmax), time to attain Cmax (tmax), apparent terminal elimination half-life (t½)
Total radioactivity in whole blood
Time frame: Days 1 to 6 and up to Day 9
area under the plasma concentration (AUC) - time curve from time zero to infinity (AUCinf), area under the plasma concentration - time curve from time zero to time of last measurable concentration (AUClast), maximum concentration (Cmax), time to attain Cmax (tmax), apparent terminal elimination half-life (t½)
Radioactivity ratio of plasma / blood
Time frame: Days 1 to 6 and up to Day 9
ratio concentrations per time point and AUC
Radioactivity excretion in urine
Time frame: Urine: Days 1-6 and up to Day 25
excretion rate and cumulative excretion
Radioactivity excretion in feces
Time frame: Days 1-6 and up to Day 25
excretion rate and cumulative excretion
Radioactivity excretion in urine and feces
Time frame: Urine: Days 1-6 and up to Day 25
excretion rate and cumulative excretion
ASP3652 in plasma
Time frame: Days 1 to 6 and up to Day 9
AUCinf, AUClast, Cmax, tmax, t1/2, apparent clearance after oral administration at steady state (CL/F), volume of terminal phase distribution at steady state (Vz/F)
ASP3652 in urine
Time frame: Days 1-6 and up to Day 25
cumulative amount of unchanged drug excreted into the urine from time zero to infinity after single dose (Aeinf), cumulative amount of unchanged drug excreted into the urine from time zero to time of last measurable concentration (Aelast), renal clearance of the drug from plasma (CLR), percentage of unchanged drug excreted into the urine from time zero to infinity after single dose % of dose excreted (Aeinf%), percentage of unchanged drug excreted into the urine from time zero to time of last measurable concentration (Aelast%)
Ratio ASP3652 to 14C-radioactivity for AUCinf
Time frame: Days 1 to 6 and up to Day 9
area under the plasma concentration (AUC) - time curve from time zero to infinity (AUCinf)
1 secondary outcome
Safety and tolerability after a single dose
Time frame: Screening (Day 22 to Day 2) to End of Study Visit (7 to 14 days after (early) discharge)
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 28 Jan 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.
Central Contact 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 ASP3652 in people with Healthy Subjects and Pharmacokinetics of ASP3652, 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 3 inclusion and 3 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 28 Jan 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?
Total radioactivity in plasma (time frame: Days 1 to 6 and up to Day 9). The study lists 9 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 28 Jan 2014.