Healthy VolunteersPhase 1NCT02693613
Pharmacokinetic Study of ASP1517 With Kremezin®
A Phase 1 study testing ASP1517 and Kremezin® in people with Healthy Volunteers, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
The objective of this study is to evaluate the effect of Kremezin® on the pharmacokinetics of single dose of ASP1517 in healthy non-elderly adult male subjects when administered concomitantly or in a time separated manner. 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 Volunteers
- What is being tested?
- ASP1517 and Kremezin®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2016to Apr 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 (BMI) (at screening): ≥17.6 and <26.4 kg/m2
- Subject must agree to use contraception consisting of two established forms (1 of which must be a barrier method) starting at the time of informed consent and continuing throughout the treatment period and for 84days after ASP1517 administration in the last period:
- 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 in the last period.
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 (Day -1).
- Received or is scheduled to receive medications (including over-the-counter [OTC] drugs) within 7 days before the hospital admission day of the Period 1 (Day -1).
- Received or is scheduled to receive supplements within 7 days before the hospital admission day of the Period 1 (Day -1).
- Deviates from any of the normal range of blood pressure, pulse rate, body temperature and standard 12-lead electrocardiogram (ECG) specified at screening or the hospital admission day of the Period 1 (Day -1).
- Meets any of the following criteria for laboratory tests at screening or the hospital admission day of the Period 1 (Day -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.
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- Development of (an) upper gastrointestinal symptoms within seven days before the hospital admission day of the Period 1 (Day -1).
- Concurrent or previous hepatic disease, heart disease, respiratory disease, gastrointestinal disease, gastrointestinal obstruction,oesophageal varices, renal disease, endocrine disease, cerebrovascular disorder, malignant tumor, retinal neovascular lesions and macular edema.
- Concurrent chronic constipation or diarrhoea.
- 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: Pharmacokinetic Study of ASP1517 - Evaluation of the Effect of Kremezin® on the Pharmacokinetics of ASP1517 in Non-elderly Healthy Adult Male Subjects, When Administered Concomitantly or in a Time Separated Manner.
The objective of this study is to evaluate the effect of Kremezin® on the pharmacokinetics of single dose of ASP1517 in healthy non-elderly adult male subjects when administered concomitantly or in a time separated manner.
- Conditions
- Healthy Volunteers
- Being tested
- ASP1517, Kremezin®
- Keywords
- Drug-drug interaction, Kremezin, Pharmacokinetics, ASP1517
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP1517Drug
Oral
Kremezin®Drug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Treatment arm includes 4 periods, single dose of ASP1517 alone, single dose of ASP1517 + Kremezin® without a time lag, single dose of ASP1517 + Kremezin® with a time lag (1 h before ASP1517 administration) and single dose of ASP1517 + Kremezin® with a time lag (1 h after ASP1517 administration) Receives: Drug: ASP1517; Drug: Kremezin® |
| Group 2 | Experimental | Treatment arm includes 3 periods, single dose of ASP1517 alone, single dose of ASP1517 + Kremezin® with a time lag (2 h before ASP1517 administration) and single dose of ASP1517 + Kremezin® with a time lag (2 h after ASP1517 administration) Receives: Drug: ASP1517; Drug: Kremezin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) parameter of ASP1517: AUCinf
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
Measured: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
PK parameter of ASP1517: Cmax
Cmax: Maximum concentration
Measured: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
Secondary outcomes (10)
PK parameters of ASP1517: AUClast
AUClast: Area under the concentration-time curve from the time of dosing extrapolated to the last measurable concentration
Measured: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
PK parameters of ASP1517: CL/F
CL/F: Apparent total systemic clearance
Measured: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
PK parameters of ASP1517: t1/2
t1/2: Terminal elimination half-life
Measured: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
PK parameters of ASP1517: tmax
tmax: Time of Cmax
Measured: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
PK parameters of ASP1517: tlag
tlag: Time point prior to the time point corresponding to the first measurable (non-zero) concentration
Measured: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
PK parameters of ASP1517: Vz/F
Vz/F: Apparent volume of distribution during the terminal elimination phase
Measured: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
Safety assessed by Adverse events
Measured: Up to 72 hours after final study drug dosing
Safety assessed by Vital signs
Supine blood pressure, supine pulse rate and axillary body temperature
Measured: Up to 72 hours after each study drug dosing
Safety assessed by Laboratory tests
Hematology, blood biochemistry and urinalysis
Measured: Up to 72 hours after each study drug dosing
Safety assessed by Standard 12-lead ECG
ECG: Electrocardiogram
Measured: Up to 72 hours after each study drug dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 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
- NCT02693613
- Sponsor's protocol ID
- 1517-CL-0204
- Status last verified
- May 2016
- First submitted
- 3 Feb 2016
- Last updated
- 21 Jun 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 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of ASP1517 - Evaluation of the Effect of Kremezin® on the Pharmacokinetics of ASP1517 in Non-elderly Healthy Adult Male Subjects, When Administered Concomitantly or in a Time Separated Manner.
- ClinicalTrials.gov ID
- NCT02693613
- Acronym / sponsor ID
- 1517-CL-0204
- Conditions
- Healthy Volunteers
- Keywords
- Drug-drug interaction, Kremezin, Pharmacokinetics, ASP1517
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Kyntra Bio
- Study start
- Feb 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 29 Feb 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 Kremezin® on the pharmacokinetics of single dose of ASP1517 in healthy non-elderly adult male subjects when administered concomitantly or in a time separated manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: ASP1517, Drug: Kremezin®Treatment arm includes 4 periods, single dose of ASP1517 alone, single dose of ASP1517 + Kremezin® without a time lag, single dose of ASP1517 + Kremezin® with a time lag (1 h before ASP1517 administration) and single dose of ASP1517 + Kremezin® with a time lag (1 h after ASP1517 administration) |
| Group 2 | Experimental | Drug: ASP1517, Drug: Kremezin®Treatment arm includes 3 periods, single dose of ASP1517 alone, single dose of ASP1517 + Kremezin® with a time lag (2 h before ASP1517 administration) and single dose of ASP1517 + Kremezin® with a time lag (2 h after ASP1517 administration) |
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 (BMI) (at screening): ≥17.6 and <26.4 kg/m2
- Subject must agree to use contraception consisting of two established forms (1 of which must be a barrier method) starting at the time of informed consent and continuing throughout the treatment period and for 84days after ASP1517 administration in the last period:
- 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 in the last period.
Key exclusion criteria (12 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 (Day -1).
- Received or is scheduled to receive medications (including over-the-counter [OTC] drugs) within 7 days before the hospital admission day of the Period 1 (Day -1).
- Received or is scheduled to receive supplements within 7 days before the hospital admission day of the Period 1 (Day -1).
- Deviates from any of the normal range of blood pressure, pulse rate, body temperature and standard 12-lead electrocardiogram (ECG) specified at screening or the hospital admission day of the Period 1 (Day -1).
- Meets any of the following criteria for laboratory tests at screening or the hospital admission day of the Period 1 (Day -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.
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 | Group 1, Group 2 |
| Kremezin®Oral | Drug | Group 1, Group 2 |
Primary outcome
Pharmacokinetics (PK) parameter of ASP1517: AUCinf
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
PK parameter of ASP1517: Cmax
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
Cmax: Maximum concentration
10 secondary outcomes
PK parameters of ASP1517: AUClast
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
PK parameters of ASP1517: CL/F
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
PK parameters of ASP1517: t1/2
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
PK parameters of ASP1517: tmax
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
PK parameters of ASP1517: tlag
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
PK parameters of ASP1517: Vz/F
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
Safety assessed by Adverse events
Time frame: Up to 72 hours after final study drug dosing
Safety assessed by Vital signs
Time frame: Up to 72 hours after each study drug dosing
Safety assessed by Laboratory tests
Time frame: Up to 72 hours after each study drug dosing
Safety assessed by Standard 12-lead ECG
Time frame: Up to 72 hours after each study drug dosing
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 21 Jun 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 and Kremezin® in people with Healthy Volunteers, 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 12 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 21 Jun 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: AUCinf (time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing). 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 21 Jun 2016.