Healthy SubjectsPhase 1NCT02805374
A Food Effect Study to Evaluate the Pharmacokinetics of ASP1517
A Phase 1 study testing ASP1517 in people with Healthy Subjects, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
The objective of this study is to evaluate the effect of food on the pharmacokinetics of a single oral dose of ASP1517 in non-elderly healthy adult male subjects. Read more about this study
- Who is it for?
- Ages 20 to 44 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- ASP1517
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2016to Aug 2016
- 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 44 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight: ≥50.0 kg and <80.0 kg
- Body-mass index : ≥17.6 and <26.4 kg/m2
- Subject must agree to use two of the established contraceptive methods after informed consent acquisition through 84 days after the last administration of the study drug.
- Subject must agree not to donate sperm after informed consent acquisition through 84 days after the last administration of the study drug.
Who cannot join
- Received or is scheduled to receive any investigational drugs in other clinical trials or post-marketing studies within 120 days before screening or during the period from screening to the hospital admission day of Period 1
- Received or is scheduled to receive medications (including over-the-counter [OTC] drugs) within 7 days before the hospital admission day of Period 1
- Received or is scheduled to receive supplements within 7 days before the hospital admission day of the Period 1
- Deviates from any of the normal range of blood pressure, pulse rate, body temperature and standard 12-lead electrocardiogram (ECG) at screening or the hospital admission day of Period 1
- Meets any of the criteria for laboratory tests at screening or the hospital admission day of Period 1. Normal ranges of each test specified at the test/assay organization will be used as the normal ranges in this study.
- Concurrent or previous drug allergies.
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- Development of (an) upper gastrointestinal symptom(s) within seven days before the hospital admission day of Period 1.
- Concurrent or previous hepatic disease, heart disease, respiratory disease, gastrointestinal disease, renal disease, endocrine disease, cerebrovascular disorder, malignant tumor, retinal neovascular lesions and macular edema.
- A history of digestive tract excision.
- Previous use of hypoxia inducible factor-prolyl hydroxylase inhibitors (HIF-PHI) such as ASP1517 (FG-4592), YM311(FG-2216) or erythropoietin products.
- Excessive alcohol or smoking habit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ASP1517 Pharmacokinetic Study - Evaluation of Food Effect on the Pharmacokinetics of ASP1517
The objective of this study is to evaluate the effect of food on the pharmacokinetics of a single oral dose of ASP1517 in non-elderly healthy adult male subjects.
- Conditions
- Healthy Subjects
- Being tested
- ASP1517
- Keywords
- Pharmacokinetics, ASP1517, Food effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP1517Drug
Oral
| Study group | Role | What they receive |
|---|---|---|
| ASP1517 fasting then fed | Experimental | Subjects will receive a single oral dose of ASP1517 under fasting conditions in period 1, then subjects will receive a single oral dose of ASP1517 under fed conditions in period 2. Receives: Drug: ASP1517 |
| ASP1517 fed then fasting | Experimental | Subjects will receive a single oral dose of ASP1517 under fed conditions in period 1, then subjects will receive a single oral dose of ASP1517 under fasting conditions in period 2. Receives: Drug: ASP1517 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) parameter of ASP1517 in Plasma: AUCinf
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
Measured: Up to Day 4 of each treatment period
PK parameter of ASP1517 in Plasma: Cmax
Cmax: Maximum concentration
Measured: Up to Day 4 of each treatment period
Secondary outcomes (14)
PK parameter of ASP1517 in Plasma: AUClast
AUClast: Area under the concentration-time curve from the time of dosing to the last measurable concentration
Measured: Up to Day 4 of each treatment period
PK parameter of ASP1517 in Plasma: CL/F
CL/F: Apparent total systemic clearance
Measured: Up to Day 4 of each treatment period
PK parameter of ASP1517 in Plasma: λz
λz: Terminal rate constant
Measured: Up to Day 4 of each treatment period
PK parameter of ASP1517 in Plasma: MRTinf
MRTinf: Mean residence time extrapolated to infinity
Measured: Up to Day 4 of each treatment period
PK parameter of ASP1517 in Plasma: t1/2
t1/2: Terminal elimination half-life
Measured: Up to Day 4 of each treatment period
PK parameter of ASP1517 in Plasma: tmax
tmax: Time of Cmax
Measured: Up to Day 4 of each treatment period
PK parameter of ASP1517 in Plasma: tlag
tlag: Lag time
Measured: Up to Day 4 of each treatment period
PK parameter of ASP1517 in Plasma: Vz/F
Vz/F: Apparent volume of distribution during the terminal elimination phase
Measured: Up to Day 4 of each treatment period
PK parameter of ASP1517 in Urine: Ae
Ae: Cumulative amount of ASP1517 excreted into urine
Measured: Up to Day 4 of each treatment period
PK parameter of ASP1517 in Urine: CLR
CLR: Renal clearance
Measured: Up to Day 4 of each treatment period
Safety assessed by adverse events
Measured: Up to Day 9 of Period 2
Number of participants with abnormal vital signs and/or adverse events during treatment period
Measured: Up to Day 9 of Period 2
Number of participants with abnormal laboratory values and/or adverse events during treatment period
Measured: Up to Day 9 of Period 2
Number of participants with abnormal standard 12-Lead ECG and/or adverse events during treatment period
ECG: Electrocardiogram
Measured: Up to Day 9 of Period 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2016
- Study completionAug 2016
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyntra Bio
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805374
- Sponsor's protocol ID
- 1517-CL-0202
- Status last verified
- Aug 2016
- First submitted
- 16 Jun 2016
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASP1517 Pharmacokinetic Study - Evaluation of Food Effect on the Pharmacokinetics of ASP1517
- ClinicalTrials.gov ID
- NCT02805374
- Acronym / sponsor ID
- 1517-CL-0202
- Conditions
- Healthy Subjects
- Keywords
- Pharmacokinetics, ASP1517, Food effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Kyntra Bio
- Study start
- Jul 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 20 Jun 2016 (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.
The objective of this study is to evaluate the effect of food on the pharmacokinetics of a single oral dose of ASP1517 in non-elderly healthy adult male subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASP1517 fasting then fed | Experimental | Drug: ASP1517Subjects will receive a single oral dose of ASP1517 under fasting conditions in period 1, then subjects will receive a single oral dose of ASP1517 under fed conditions in period 2. |
| ASP1517 fed then fasting | Experimental | Drug: ASP1517Subjects will receive a single oral dose of ASP1517 under fed conditions in period 1, then subjects will receive a single oral dose of ASP1517 under fasting conditions in period 2. |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body weight: ≥50.0 kg and <80.0 kg
- Body-mass index : ≥17.6 and <26.4 kg/m2
- Subject must agree to use two of the established contraceptive methods after informed consent acquisition through 84 days after the last administration of the study drug.
- Subject must agree not to donate sperm after informed consent acquisition through 84 days after the last administration of the study drug.
Key exclusion criteria (11 listed)
- Received or is scheduled to receive any investigational drugs in other clinical trials or post-marketing studies within 120 days before screening or during the period from screening to the hospital admission day of Period 1
- Received or is scheduled to receive medications (including over-the-counter [OTC] drugs) within 7 days before the hospital admission day of Period 1
- Received or is scheduled to receive supplements within 7 days before the hospital admission day of the Period 1
- Deviates from any of the normal range of blood pressure, pulse rate, body temperature and standard 12-lead electrocardiogram (ECG) at screening or the hospital admission day of Period 1
- Meets any of the criteria for laboratory tests at screening or the hospital admission day of Period 1. Normal ranges of each test specified at the test/assay organization will be used as the normal ranges in this study.
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 |
|---|---|---|
| ASP1517Oral | Drug | ASP1517 fasting then fed, ASP1517 fed then fasting |
Primary outcome
Pharmacokinetics (PK) parameter of ASP1517 in Plasma: AUCinf
Time frame: Up to Day 4 of each treatment period
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
PK parameter of ASP1517 in Plasma: Cmax
Time frame: Up to Day 4 of each treatment period
Cmax: Maximum concentration
14 secondary outcomes
PK parameter of ASP1517 in Plasma: AUClast
Time frame: Up to Day 4 of each treatment period
PK parameter of ASP1517 in Plasma: CL/F
Time frame: Up to Day 4 of each treatment period
PK parameter of ASP1517 in Plasma: λz
Time frame: Up to Day 4 of each treatment period
PK parameter of ASP1517 in Plasma: MRTinf
Time frame: Up to Day 4 of each treatment period
PK parameter of ASP1517 in Plasma: t1/2
Time frame: Up to Day 4 of each treatment period
PK parameter of ASP1517 in Plasma: tmax
Time frame: Up to Day 4 of each treatment period
PK parameter of ASP1517 in Plasma: tlag
Time frame: Up to Day 4 of each treatment period
PK parameter of ASP1517 in Plasma: Vz/F
Time frame: Up to Day 4 of each treatment period
PK parameter of ASP1517 in Urine: Ae
Time frame: Up to Day 4 of each treatment period
PK parameter of ASP1517 in Urine: CLR
Time frame: Up to Day 4 of each treatment period
Safety assessed by adverse events
Time frame: Up to Day 9 of Period 2
Number of participants with abnormal vital signs and/or adverse events during treatment period
Time frame: Up to Day 9 of Period 2
Number of participants with abnormal laboratory values and/or adverse events during treatment period
Time frame: Up to Day 9 of Period 2
Number of participants with abnormal standard 12-Lead ECG and/or adverse events during treatment period
Time frame: Up to Day 9 of Period 2
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 24 Aug 2016.
- Individual participant dataSharing planned: Undecided
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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.
Medical Director study director
Astellas Pharma Inc
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 ASP1517 in people with Healthy Subjects, run by Astellas Pharma Inc at 1 site in Japan.
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 4 inclusion and 11 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 24 Aug 2016. 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 Japan. 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 (PK) parameter of ASP1517 in Plasma: AUCinf (time frame: Up to Day 4 of each treatment period). The study lists 2 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 24 Aug 2016.