Healthy SubjectsPhase 1NCT02952040
A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP1517 and Lanthanum Carbonate Hydrate
A Phase 1 study testing ASP1517 and Lanthanum carbonate hydrate 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 lanthanum carbonate hydrate on the pharmacokinetics (PK) of ASP1517 in non-elderly healthy 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 and Lanthanum carbonate hydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2016to Dec 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 (at screening): ≥50.0 kg and <80.0 kg
- Body-mass index (at screening): ≥17.6 and <26.4 kg/m2 [Body-mass index = Body weight (kg)/(Height (m))2]
- Subject must agree to use contraception consisting of two established forms specified below starting at the time of informed consent and continuing throughout the treatment period and for 84 days after the last administration of ASP1517.
- Subject must agree not to donate sperm starting at the time of informed consent and continuing throughout 84 days after the last administration of ASP1517.
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 the Period 1.
- Received or is scheduled to receive medications (including over-the-counter drugs) or 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 at screening or the hospital admission day of the Period 1.
- Meets any of the following criteria for laboratory tests at screening or the hospital admission day of the Period 1. Normal ranges of each test specified at the study site or the test/assay organization will be used as the normal ranges in this study.
- Concurrent or previous drug allergies.
- Development of (an) upper gastrointestinal symptom(s) within 7 days before the hospital admission day of the Period 1.
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- Concurrent or previous hepatic disease, heart disease, respiratory disease, peritoneum inflammation.
- A history of abdominal surgery, digestive tract excision.
- Concurrent or previous renal disease, endocrine disease, cerebrovascular disorder, malignant tumor, retinal neovascular lesions.
- Previous use of hypoxia inducible factor-prolyl hydroxylase inhibitors (HIF-PHI) such as ASP1517 (FG-4592), YM311 (FG-2216), erythropoietin products or lanthanum carbonate hydrate.
- Excessive alcohol or smoking habit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Study of ASP1517 - Evaluation of the Effect of Lanthanum Carbonate Hydrate on the Pharmacokinetics of ASP1517 in Non-elderly Healthy Adult Male Subjects -
The objective of this study is to evaluate the effect of lanthanum carbonate hydrate on the pharmacokinetics (PK) of ASP1517 in non-elderly healthy male subjects.
- Conditions
- Healthy Subjects
- Being tested
- ASP1517, Lanthanum carbonate hydrate
- Keywords
- ASP1517, Pharmacokinetics, Drug-drug interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP1517Drug
Oral dose
Lanthanum carbonate hydrateDrug
Also called Fosrenol
Oral dose
| Study group | Role | What they receive |
|---|---|---|
| ASP1517 alone period preceding group | Experimental | Subjects will receive a single oral dose of ASP1517 alone in period 1, then subjects will receive a single oral dose of ASP1517 with lanthanum carbonate hydrate in period 2. Receives: Drug: ASP1517; Drug: Lanthanum carbonate hydrate |
| ASP1517+lanthanum period preceding group | Experimental | Subjects will receive a single oral dose of ASP1517 with lanthanum carbonate hydrate in period 1, then subjects will receive a single oral dose of ASP1517 alone in period 2. Receives: Drug: ASP1517; Drug: Lanthanum carbonate hydrate |
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 72hr after each dosing
PK parameter of ASP1517 in plasma: AUC24h
AUC24h: Area under the concentration-time curve from the time of dosing to 24h
Measured: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: Cmax
Cmax: Maximum concentration
Measured: Up to 72hr after each dosing
Secondary outcomes (16)
PK parameter of ASP1517 in plasma: AUClast
AUC last: Area under the concentration-time curve from the time of dosing to the last measurable concentration
Measured: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: CL/F
CL/F: Apparent total systemic clearance
Measured: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: t1/2
t1/2: Terminal elimination half-life
Measured: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: Lambda z
Lambda z: Terminal elimination rate constant
Measured: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: MRTinf
MRTinf: Mean residence time from the time of dosing extrapolated to time infinity
Measured: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: tmax
tmax : Time of Cmax
Measured: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: tlag
tlag: Time point prior to the time point corresponding to the first measurable (non-zero) concentration
Measured: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: Vz/F
Vz/F: Apparent volume of distribution during the terminal elimination phase after single extra-vascular dosing
Measured: Up to 72hr after each dosing
Safety assessed by incidence of adverse events
Measured: Up to 7 days after drug dosing of period 2
Safety assessed by supine blood pressure
Measured: Up to 7 days after drug dosing of period 2
Safety assessed by supine pulse rate
Measured: Up to 7 days after drug dosing of period 2
Safety assessed by axillary body temperature
Measured: Up to 7 days after drug dosing of period 2
Safety assessed by Laboratory tests: Hematology
Measured: Up to 7 days after drug dosing of period 2
Safety assessed by Laboratory tests: Blood biochemistry
Measured: Up to 7 days after drug dosing of period 2
Safety assessed by Laboratory tests: Urinalysis
Measured: Up to 7 days after drug dosing of period 2
Safety assessed by 12-lead electrocardiogram
Measured: Up to 7 days after drug dosing 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 posted2 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2016
- Study completionDec 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
- 18 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
- NCT02952040
- Sponsor's protocol ID
- 1517-CL-0205
- Status last verified
- Jan 2017
- First submitted
- 31 Oct 2016
- Last updated
- 25 Jan 2017
- 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 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of ASP1517 - Evaluation of the Effect of Lanthanum Carbonate Hydrate on the Pharmacokinetics of ASP1517 in Non-elderly Healthy Adult Male Subjects -
- ClinicalTrials.gov ID
- NCT02952040
- Acronym / sponsor ID
- 1517-CL-0205
- Conditions
- Healthy Subjects
- Keywords
- ASP1517, Pharmacokinetics, Drug-drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Kyntra Bio
- Study start
- Nov 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Nov 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 lanthanum carbonate hydrate on the pharmacokinetics (PK) of ASP1517 in non-elderly healthy 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 alone period preceding group | Experimental | Drug: ASP1517, Drug: Lanthanum carbonate hydrateSubjects will receive a single oral dose of ASP1517 alone in period 1, then subjects will receive a single oral dose of ASP1517 with lanthanum carbonate hydrate in period 2. |
| ASP1517+lanthanum period preceding group | Experimental | Drug: ASP1517, Drug: Lanthanum carbonate hydrateSubjects will receive a single oral dose of ASP1517 with lanthanum carbonate hydrate in period 1, then subjects will receive a single oral dose of ASP1517 alone 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 (at screening): ≥50.0 kg and <80.0 kg
- Body-mass index (at screening): ≥17.6 and <26.4 kg/m2 [Body-mass index = Body weight (kg)/(Height (m))2]
- Subject must agree to use contraception consisting of two established forms specified below starting at the time of informed consent and continuing throughout the treatment period and for 84 days after the last administration of ASP1517.
- Subject must agree not to donate sperm starting at the time of informed consent and continuing throughout 84 days after the last administration of ASP1517.
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 the Period 1.
- Received or is scheduled to receive medications (including over-the-counter drugs) or 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 at screening or the hospital admission day of the Period 1.
- Meets any of the following criteria for laboratory tests at screening or the hospital admission day of the Period 1. Normal ranges of each test specified at the study site or the test/assay organization will be used as the normal ranges in this study.
- Concurrent or previous drug allergies.
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 dose | Drug | ASP1517 alone period preceding group, ASP1517+lanthanum period preceding group |
| Lanthanum carbonate hydrateAlso: FosrenolOral dose | Drug | ASP1517 alone period preceding group, ASP1517+lanthanum period preceding group |
Primary outcome
Pharmacokinetics (PK) parameter of ASP1517 in plasma: AUCINF
Time frame: Up to 72hr after each dosing
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
PK parameter of ASP1517 in plasma: AUC24h
Time frame: Up to 72hr after each dosing
AUC24h: Area under the concentration-time curve from the time of dosing to 24h
PK parameter of ASP1517 in plasma: Cmax
Time frame: Up to 72hr after each dosing
Cmax: Maximum concentration
16 secondary outcomes
PK parameter of ASP1517 in plasma: AUClast
Time frame: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: CL/F
Time frame: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: t1/2
Time frame: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: Lambda z
Time frame: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: MRTinf
Time frame: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: tmax
Time frame: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: tlag
Time frame: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: Vz/F
Time frame: Up to 72hr after each dosing
Safety assessed by incidence of adverse events
Time frame: Up to 7 days after drug dosing of period 2
Safety assessed by supine blood pressure
Time frame: Up to 7 days after drug dosing of period 2
Safety assessed by supine pulse rate
Time frame: Up to 7 days after drug dosing of period 2
Safety assessed by axillary body temperature
Time frame: Up to 7 days after drug dosing of period 2
Safety assessed by Laboratory tests: Hematology
Time frame: Up to 7 days after drug dosing of period 2
Safety assessed by Laboratory tests: Blood biochemistry
Time frame: Up to 7 days after drug dosing of period 2
Safety assessed by Laboratory tests: Urinalysis
Time frame: Up to 7 days after drug dosing of period 2
Safety assessed by 12-lead electrocardiogram
Time frame: Up to 7 days after drug dosing 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 25 Jan 2017.
- 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 and Lanthanum carbonate hydrate 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 25 Jan 2017. 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 72hr after each dosing). The study lists 3 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 25 Jan 2017.