PharmacokineticsPhase 1NCT01958047
A Study to Assess the Effect of Race on How a Single Dose of ASP3652 is Taken up, Metabolized and Distributed Through the Bodies of Young, Healthy Male and Female Subjects, and Its Safety and Tolerability
A Phase 1 study testing ASP3652 in people with Pharmacokinetics and Pharmacodynamics, run by Astellas Pharma Europe B.V. at 1 site in United Kingdom.
Trial summary
This study investigates how ASP3652 is taken up, broken down, and distributed through the body and excreted in individuals of different races. The study also investigates levels of biochemical markers in the bloodstream, and determines how safe the study drug is and how well it is tolerated after dosing. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Pharmacodynamics, Healthy Subjects
- 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
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2012to Sep 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject is a healthy male or female subject from Caucasian, Japanese, Black/African or Chinese origin. Both parents and all 4 grandparents should be of the same race.
- Subjects of Japanese or Chinese origin should be born in their respective countries and should not have lived outside of their countries for more than 5 years and 10 years, respectively.
- The subject has a Body Mass Index (BMI) in the range 18.5 - 30.0 kg/m2, inclusive (subject from Caucasian or Black/African origin) or in the range 17.5 - 29.0 kg/m2, inclusive (subject from Japanese or Chinese origin). The subject weighs at least 50 kg (subject from Caucasian or Black/African origin) or at least 45 kg (subject from Japanese or Chinese origin).
Who cannot join
- Female subject who is pregnant, has been pregnant within 6 months before screening, or breast feeding within 3 months before screening.
- Known or suspected hypersensitivity to ASP3652 or any components of the formulation used.
- The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to admission to the Clinical Unit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Single Dose of ASP3652 in Caucasian, Japanese, Black/African and Chinese Healthy Male and Female Subjects
This study investigates how ASP3652 is taken up, broken down, and distributed through the body and excreted in individuals of different races. The study also investigates levels of biochemical markers in the bloodstream, and determines how safe the study drug is and how well it is tolerated after dosing. A further aim is to look at how the processes of metabolism, distribution and excretion of the study drug are possibly altered by the daily diet of the volunteers taking part.
Read the detailed description
This is an open label study to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of a single dose of ASP3652 in healthy male and female subjects from Caucasian, Japanese, Black/African and Chinese origin.
A total of 64 healthy male and female subjects are included in this study (16 subjects per race group). Each race group comprises 8 female subjects and 8 male subjects.
Screening assessments are performed from Day -22 to Day -2, and subjects are admitted to the clinic on Day -1, where they remain until Day 4. On Day 1, the subjects receive a single oral dose of ASP3652, and are discharged on Day 4 when all assessments have been performed and if there are no medical reasons to stay longer. An end of study visit (ESV) is performed 7-14 days after discharge.
For each race group, plasma samples for PK and PD analysis are collected. Vital signs, safety electrocardiogram (ECG) measurements, safety laboratory assessments, physical examination, adverse events (AEs) and concomitant medications are monitored throughout study.
In order to identify potential relationships between dietary intake and the PK of a single dose of ASP3652, all subjects record their diet for 3 days during the screening period in order to assess daily dietary intake (including total daily caloric intake; daily cholesterol intake; and total fat, saturated fat, carbohydrate and protein as a percentage of total calories).
- Conditions
- Pharmacokinetics, Pharmacodynamics, Healthy Subjects, Effect of Race
- Being tested
- ASP3652
- Keywords
- Phase I, ASP3652, Single dose, Dietary intake
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 |
|---|---|---|
| ASP3652 | Experimental | One single dose Receives: Drug: ASP3652 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of ASP3652 in plasma measured by Cmax
maximum observed plasma concentration (Cmax)
Measured: Day 1 to Day 4 (16 blood samples taken)
Pharmacokinetics of ASP3652 in plasma measured by AUClast
area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Measured: Day 1 to Day 4 (16 blood samples taken)
Pharmacokinetics of ASP3652 in plasma measured by AUCinf
area under the plasma concentration-time curve from time zero extrapolated to the infinite time (AUCinf)
Measured: Day 1 to Day 4 (16 blood samples taken)
Pharmacokinetics of ASP3652 in plasma measured by tmax
time to attain Cmax (tmax)
Measured: Day 1 to Day 4 (16 blood samples taken)
Pharmacokinetics of ASP3652 in plasma measured by tlag
PK lag time (tlag)
Measured: Day 1 to Day 4 (16 blood samples taken)
Pharmacokinetics of ASP3652 in plasma measured by t1/2
apparent terminal elimination half-life (t1/2)
Measured: Day 1 to Day 4 (16 blood samples taken)
Pharmacokinetics of ASP3652 in plasma measured by Vz/F
apparent volume of terminal phase distribution at steady state (Vz/F)
Measured: Day 1 to Day 4 (16 blood samples taken)
Pharmacokinetics of ASP3652 in plasma measured by CL/F
apparent clearance after oral administration at steady state (CL/F)
Measured: Day 1 to Day 4 (16 blood samples taken)
Pharmacokinetics of ASP3652 in plasma measured by Vz/F/kg
body weight-adjusted apparent volume of terminal phase distribution at steady state (Vz/F/kg)
Measured: Day 1 to Day 4 (16 blood samples taken)
Pharmacokinetics of ASP3652 in plasma measured by CL/F/kg
body weight-adjusted apparent clearance after oral administration at steady state (CL/F/kg)
Measured: Day 1 to Day 4 (16 blood samples taken)
Pharmacokinetics of ASP3652 metabolites in plasma measured by Cmax
Measured: Day 1 to Day 4 (16 blood samples taken)
Pharmacokinetics of ASP3652 metabolites in plasma measured by AUClast
Measured: Day 1 to Day 4 (16 blood samples taken)
Pharmacokinetics of ASP3652 metabolites in plasma measured by AUCinf
Measured: Day 1 to Day 4 (16 blood samples taken)
Pharmacokinetics of ASP3652 metabolites in plasma measured by tmax
Measured: Day 1 to Day 4 (16 blood samples taken)
Pharmacokinetics of ASP3652 metabolites in plasma measured by tlag
tlag
Measured: Day 1 to Day 4 (16 blood samples taken)
Pharmacokinetics of ASP3652 metabolites in plasma measured by t1/2
Measured: Day 1 to Day 4 (16 blood samples taken)
Secondary outcomes (2)
Plasma levels of arachidonoyl-ethanolamide (AEA, or anandamide), oleoyl-ethanolamide (OEA) and palmitoyl-ethanolamide (PEA) after a single dose of ASP3652
maximum response (Rmax), time of the maximum response (tmax R), area under the response curve (AUR)
Measured: Day 1 to Day 4 (12 blood samples taken)
Safety and tolerability of a single dose of ASP3652
vital signs, safety electrocardiogram measurements, safety laboratory assessments, physical examination and adverse events (AEs)
Measured: Screening to ESV (at least 39 safety assessments)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startJul 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clincial Study Manager, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958047
- Sponsor's protocol ID
- 3652-CL-0054
- Other IDs
- 2012-001476-11
- Status last verified
- Oct 2013
- First submitted
- 4 Oct 2013
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Single Dose of ASP3652 in Caucasian, Japanese, Black/African and Chinese Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT01958047
- Acronym / sponsor ID
- 3652-CL-0054
- Conditions
- Pharmacokinetics, Pharmacodynamics, Healthy Subjects, Effect of Race
- Keywords
- Phase I, ASP3652, Single dose, Dietary intake
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 8 Oct 2013 (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 investigates how ASP3652 is taken up, broken down, and distributed through the body and excreted in individuals of different races. The study also investigates levels of biochemical markers in the bloodstream, and determines how safe the study drug is and how well it is tolerated after dosing. A further aim is to look at how the processes of metabolism, distribution and excretion of the study drug are possibly altered by the daily diet of the volunteers taking part.
Detailed description
This is an open label study to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of a single dose of ASP3652 in healthy male and female subjects from Caucasian, Japanese, Black/African and Chinese origin.
A total of 64 healthy male and female subjects are included in this study (16 subjects per race group). Each race group comprises 8 female subjects and 8 male subjects.
Screening assessments are performed from Day -22 to Day -2, and subjects are admitted to the clinic on Day -1, where they remain until Day 4. On Day 1, the subjects receive a single oral dose of ASP3652, and are discharged on Day 4 when all assessments have been performed and if there are no medical reasons to stay longer. An end of study visit (ESV) is performed 7-14 days after discharge.
For each race group, plasma samples for PK and PD analysis are collected. Vital signs, safety electrocardiogram (ECG) measurements, safety laboratory assessments, physical examination, adverse events (AEs) and concomitant medications are monitored throughout study.
In order to identify potential relationships between dietary intake and the PK of a single dose of ASP3652, all subjects record their diet for 3 days during the screening period in order to assess daily dietary intake (including total daily caloric intake; daily cholesterol intake; and total fat, saturated fat, carbohydrate and protein as a percentage of total calories).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASP3652 | Experimental | Drug: ASP3652One single dose |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The subject is a healthy male or female subject from Caucasian, Japanese, Black/African or Chinese origin. Both parents and all 4 grandparents should be of the same race.
- Subjects of Japanese or Chinese origin should be born in their respective countries and should not have lived outside of their countries for more than 5 years and 10 years, respectively.
- The subject has a Body Mass Index (BMI) in the range 18.5 - 30.0 kg/m2, inclusive (subject from Caucasian or Black/African origin) or in the range 17.5 - 29.0 kg/m2, inclusive (subject from Japanese or Chinese origin). The subject weighs at least 50 kg (subject from Caucasian or Black/African origin) or at least 45 kg (subject from Japanese or Chinese origin).
Key exclusion criteria (3 listed)
- Female subject who is pregnant, has been pregnant within 6 months before screening, or breast feeding within 3 months before screening.
- Known or suspected hypersensitivity to ASP3652 or any components of the formulation used.
- The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to admission to the Clinical Unit.
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 | ASP3652 |
Primary outcome
Pharmacokinetics of ASP3652 in plasma measured by Cmax
Time frame: Day 1 to Day 4 (16 blood samples taken)
maximum observed plasma concentration (Cmax)
Pharmacokinetics of ASP3652 in plasma measured by AUClast
Time frame: Day 1 to Day 4 (16 blood samples taken)
area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Pharmacokinetics of ASP3652 in plasma measured by AUCinf
Time frame: Day 1 to Day 4 (16 blood samples taken)
area under the plasma concentration-time curve from time zero extrapolated to the infinite time (AUCinf)
Pharmacokinetics of ASP3652 in plasma measured by tmax
Time frame: Day 1 to Day 4 (16 blood samples taken)
time to attain Cmax (tmax)
Pharmacokinetics of ASP3652 in plasma measured by tlag
Time frame: Day 1 to Day 4 (16 blood samples taken)
PK lag time (tlag)
Pharmacokinetics of ASP3652 in plasma measured by t1/2
Time frame: Day 1 to Day 4 (16 blood samples taken)
apparent terminal elimination half-life (t1/2)
Pharmacokinetics of ASP3652 in plasma measured by Vz/F
Time frame: Day 1 to Day 4 (16 blood samples taken)
apparent volume of terminal phase distribution at steady state (Vz/F)
Pharmacokinetics of ASP3652 in plasma measured by CL/F
Time frame: Day 1 to Day 4 (16 blood samples taken)
apparent clearance after oral administration at steady state (CL/F)
Pharmacokinetics of ASP3652 in plasma measured by Vz/F/kg
Time frame: Day 1 to Day 4 (16 blood samples taken)
body weight-adjusted apparent volume of terminal phase distribution at steady state (Vz/F/kg)
Pharmacokinetics of ASP3652 in plasma measured by CL/F/kg
Time frame: Day 1 to Day 4 (16 blood samples taken)
body weight-adjusted apparent clearance after oral administration at steady state (CL/F/kg)
Pharmacokinetics of ASP3652 metabolites in plasma measured by Cmax
Time frame: Day 1 to Day 4 (16 blood samples taken)
Pharmacokinetics of ASP3652 metabolites in plasma measured by AUClast
Time frame: Day 1 to Day 4 (16 blood samples taken)
Pharmacokinetics of ASP3652 metabolites in plasma measured by AUCinf
Time frame: Day 1 to Day 4 (16 blood samples taken)
Pharmacokinetics of ASP3652 metabolites in plasma measured by tmax
Time frame: Day 1 to Day 4 (16 blood samples taken)
Pharmacokinetics of ASP3652 metabolites in plasma measured by tlag
Time frame: Day 1 to Day 4 (16 blood samples taken)
tlag
Pharmacokinetics of ASP3652 metabolites in plasma measured by t1/2
Time frame: Day 1 to Day 4 (16 blood samples taken)
2 secondary outcomes
Plasma levels of arachidonoyl-ethanolamide (AEA, or anandamide), oleoyl-ethanolamide (OEA) and palmitoyl-ethanolamide (PEA) after a single dose of ASP3652
Time frame: Day 1 to Day 4 (12 blood samples taken)
Safety and tolerability of a single dose of ASP3652
Time frame: Screening to ESV (at least 39 safety assessments)
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 8 Oct 2013.
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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.
Clincial 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 ASP3652 in people with Pharmacokinetics and Pharmacodynamics, 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 8 Oct 2013. 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?
Pharmacokinetics of ASP3652 in plasma measured by Cmax (time frame: Day 1 to Day 4 (16 blood samples taken)). The study lists 16 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 8 Oct 2013.