Rheumatoid ArthritisPhase 1NCT02867306
A Study to Evaluate the Pharmacokinetics of ASP1707 and Methotrexate in Patients With Rheumatoid Arthritis
A Phase 1 study testing ASP1707 and methotrexate (MTX) in people with Rheumatoid Arthritis, run by Astellas Pharma Global Development, Inc. at 1 site in Moldova.
Trial summary
The primary purpose of the study is to evaluate the effect of ASP1707 twice daily on the pharmacokinetics of once weekly oral methotrexate (MTX). This study will also evaluate the effect of MTX on multiple-dose pharmacokinetics of ASP1707, as well as safety and tolerability of coadministration of ASP1707 and MTX in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- ASP1707 and methotrexate (MTX)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteMoldova
- Study dates
- 25 Jul 2016to 30 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patient must either:
- Be of nonchildbearing potential: postmenopausal (defined as at least 2 years after last regular menstrual cycle) prior to screening and follicle-stimulating hormone (FSH) ≥ 30 IU/mL, or
- documented surgically sterile
- Or, if of childbearing potential,
- Agree not to try to become pregnant during the study and for 28 days or 5 half-lives, whichever is longer, after the final study drug administration;
- and have a negative urine pregnancy test at screening;
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- and, if heterosexually active, agree to consistently use 2 forms of highly effective birth control (at least one of which must be a barrier method) starting at screening and throughout the study period and for 28 days or 5 half-lives, whichever is longer, after the final study drug administration.
- Male patient and his female spouse/partner who is of childbearing potential must be using highly effective forms of contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and continue throughout the study period and for 60 days after the final study drug administration.
- Female patient must agree not to breastfeed starting at screening and throughout the study period, and for 28 days or 5 half-lives, whichever is longer, after the final study drug administration.
- Female patient must not donate ova starting at screening and throughout the study period, and for 28 days or 5 half-lives, whichever is longer, after the final study drug administration.
- Male patient must not donate sperm starting at screening and throughout the study period, and for 60 days after the final study drug administration.
- Patient agrees not to participate in another interventional study while on treatment.
- Patient has a body mass index (BMI) of ≤ 35 kg/m2, inclusive, and must weigh at least 50 kg at screening.
- Patient must have a clinical diagnosis of RA according to the 2010 criteria of the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) at least 6 months prior to screening.
- Patient meets the ACR 1991 revised criteria for RA Global Functional Status I or II.
- Patient must be on concomitant MTX at a stable 10 to 25 mg/week dose for ≥ 28 days prior to day 1 and throughout the study.
- Patient on other medications (excluding MTX) for the treatment or RA at the time of screening must be able to discontinue these medications 28 days or 5 half-lives (whichever is longer) before first study drug dose:
- o Hydroxychloroquine, cyclosporine, leflunomide and sulfasalazine
- Patient use of nonsteroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors, folic acid, low dose opioids, hormone replacement therapy (HRT), corticosteroids (prednisone equivalent of ≤ 5 mg/day) for treatment of RA may be allowed in the study. These medications must be stable for ≥ 28 days prior to screening and patients should remain on their regimen throughout the study. Occasional acetaminophen use (less than 2 g/day) may be allowed.
- Patient use of conventional and biologic disease-modifying antirheumatic drugs (DMARDs) used to treat RA may be allowed in this study. These medications must be stable for 4 weeks prior to the study and remain stable during the study. Prior approval for its use must be obtained from the sponsor.
Who cannot join
- Patient has a previous history of clinically significant systemic disease which might confound the results of the study or pose an additional risk in administering study drug(s) to the patient. This may include, but not be limited to, a history of drug or food allergies, uncompensated heart failure, uncontrolled diabetes mellitus, severe hepatic failure, severe pulmonary disease, or history of mental disease.
- Patient has a history of any malignancy in the past 5 years, except for adequately-treated nonmelanoma skin cancer and adequately-treated-in-situ cervical cancer.
- Patient has a positive serology test for hepatitis B surface antigen (HbsAg) or hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) 1+2 antibodies.
- Patient received any breast cancer resistance protein (BCRP) transporter inhibitors or substrates, with the exception of MTX, within 28 days or 5 half-lives, whichever is longer, prior to day 1.
- Patient with liver enzyme test abnormalities, aspartate aminotransferase (AST), alanine aminotransferase (ALT) or total bilirubin > 2 times the upper limit of normal (ULN).
- Patient has a recent history (within the last 6 months) of drug or alcohol abuse (as defined by the Investigator) or a positive urine screen for alcohol or drugs of abuse/illegal drugs at screening or check-in.
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- Patient has participated in a previous clinical study with treatment with ASP1707.
- Patient has received any investigational agent within 28 days or 5 half-lives, whichever is longer, prior to day 1.
- Patient has had any significant blood loss, donated 1 unit (450 mL) of blood, or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to day 1.
- Patient is an employee of the Astellas group or vendors involved with the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Open-label, Single-sequence, Drug Interaction Study to Evaluate the Pharmacokinetics of ASP1707 and Methotrexate in Patients With Rheumatoid Arthritis
The primary purpose of the study is to evaluate the effect of ASP1707 twice daily on the pharmacokinetics of once weekly oral methotrexate (MTX).
This study will also evaluate the effect of MTX on multiple-dose pharmacokinetics of ASP1707, as well as safety and tolerability of coadministration of ASP1707 and MTX in patients with rheumatoid arthritis (RA).
Read the detailed description
Patients will check into the clinic on Day -1 and remain in the clinic until all exit procedures have been performed on the morning of Day 10.
- Conditions
- Rheumatoid Arthritis
- Being tested
- ASP1707, methotrexate (MTX)
- Keywords
- methotrexate (MTX), Pharmacokinetics, ASP1707, Rheumatoid Arthritis (RA)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP1707Drug
Oral
methotrexate (MTX)Drug
Oral
| Study group | Role | What they receive |
|---|---|---|
| ASP1707 and methotrexate (MTX) | Experimental | On day 1 patients will receive prescribed dose of MTX. On Days 3 through 8, patients will receive ASP1707 (twice daily). On Day 9, patients will receive a single dose in the morning. A single dose of MTX will be coadministered on Day 8. Receives: Drug: ASP1707; Drug: methotrexate (MTX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of methotrexate (MTX) in plasma: AUCinf
Area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf)
Measured: Up to Day 8
Pharmacokinetics of methotrexate (MTX) in plasma: Cmax
Maximum concentration (Cmax)
Measured: Up to Day 8
Secondary outcomes (33)
Pharmacokinetics of methotrexate (MTX) in plasma: AUClast
Area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast)
Measured: Up to Day 8
Pharmacokinetics of methotrexate (MTX) in plasma: tmax
Time after dosing when Cmax occurs (tmax)
Measured: Up to Day 8
Pharmacokinetics of methotrexate (MTX) in plasma: t 1/2
Apparent terminal elimination half-life (t 1/2)
Measured: Up to Day 8
Pharmacokinetics of methotrexate (MTX) in plasma: CL/F
Apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F)
Measured: Up to Day 8
Pharmacokinetics of methotrexate (MTX) in plasma: Vz/F
Apparent volume of distribution during the terminal elimination phase (Vz/F)
Measured: Up to Day 8
Pharmacokinetics of 7-hydroxymethotrexate (7-OH-MTX) in plasma: AUClast
Measured: Up to Day 8
Pharmacokinetics of 7-hydroxymethotrexate (7-OH-MTX) in plasma: tmax
Measured: Up to Day 8
Pharmacokinetics of 7-hydroxymethotrexate (7-OH-MTX) in plasma: t 1/2
Measured: Up to Day 8
Pharmacokinetics of 7-hydroxymethotrexate (7-OH-MTX) in plasma: MPR
Metabolite to parent ratio of AUC using AUC(corr) for the metabolite (corrected by molecular weight ratio of parent to metabolite) (MPR)
Measured: Up to Day 8
Pharmacokinetics of methotrexate (MTX) in urine: Aelast
Cumulative amount of analyte excreted into the urine up to the collection time of the last measurable concentration (Aelast)
Measured: Up to Day 8
Pharmacokinetics of methotrexate (MTX) in urine: Aelast%
Percent of drug dose excreted into urine, feces or bile (Aelast) from time of dosing up to the collection time of the last measurable concentration (Aelast%)
Measured: Up to Day 8
Pharmacokinetics of methotrexate (MTX) in urine: CLR
Renal clearance (CLR)
Measured: Up to Day 8
Pharmacokinetics of 7-hydroxymethotrexate (7-OH-MTX) in urine: Aelast
Measured: Up to Day 8
Pharmacokinetics of 7-hydroxymethotrexate (7-OH-MTX) in urine: Aelast%
Measured: Up to Day 8
Pharmacokinetics of 7-hydroxymethotrexate (7-OH-MTX) in urine: CLR
Measured: Up to Day 8
Pharmacokinetics of ASP1707 in plasma: AUCtau
Area under the concentration-time curve from the time of dosing to the start of the next dosing interval (AUCtau)
Measured: Up to Day 8
Pharmacokinetics of ASP1707 in plasma: Cmax
Measured: Up to Day 8
Pharmacokinetics of ASP1707 in plasma: tmax
Measured: Up to Day 8
Pharmacokinetics of ASP1707 in plasma: CL/F
Measured: Up to Day 8
Pharmacokinetics of ASP1707 in plasma: Ctrough
Concentration immediately prior to dosing at multiple dosing (Ctrough)
Measured: Up to Day 9
Pharmacokinetics of ASP1707 in plasma: MPR
Measured: Up to Day 8
Pharmacokinetics of AS1948006 in plasma: AUCtau
Measured: Up to Day 8
Pharmacokinetics of AS1948006 in plasma: Cmax
Measured: Up to Day 8
Pharmacokinetics of AS1948006 in plasma: tmax
Measured: Up to Day 8
Pharmacokinetics of AS1948006 in plasma: Ctrough
Measured: Up to Day 8
Pharmacokinetics of AS1948006 in plasma: MPR
Measured: Up to Day 8
Safety as assessed by Adverse Events (AEs)
Measured: Up to Day 13
Safety assessed by Laboratory Test: hematology
Measured: Up to Day 13
Safety assessed by Laboratory Test: biochemistry
Measured: Up to Day 13
Safety assessed by Laboratory Test: serology
Measured: Up to Day 13
Safety assessed by Laboratory Test: urinalysis
Measured: Up to Day 13
Safety assessed by 12- lead electrocardiogram (ECG)
All ECGs should be recorded using the clinic's calibrated equipment. This overall conclusion will be recorded as normal, abnormal not clinically significant, or abnormal clinically significant.
Measured: Up to Day 10
Number of participants with Physical Examination abnormalities and/or adverse events
Measured: Up to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study start25 Jul 2016
- Primary completion30 Aug 2016
- Study completion30 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Medical Director, Study director, Astellas Pharma Global Development, Inc. (APGD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867306
- Sponsor's protocol ID
- 1707-CL-3002
- Other IDs
- 2016-001192-76, 2016
- Status last verified
- Oct 2024
- First submitted
- 11 Aug 2016
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label, Single-sequence, Drug Interaction Study to Evaluate the Pharmacokinetics of ASP1707 and Methotrexate in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02867306
- Acronym / sponsor ID
- 1707-CL-3002
- Conditions
- Rheumatoid Arthritis
- Keywords
- methotrexate (MTX), Pharmacokinetics, ASP1707, Rheumatoid Arthritis (RA)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2016 (actual)
- Primary completion
- 30 Aug 2016 (actual)
- Study completion
- 30 Aug 2016 (actual)
- First posted
- 15 Aug 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 primary purpose of the study is to evaluate the effect of ASP1707 twice daily on the pharmacokinetics of once weekly oral methotrexate (MTX).
This study will also evaluate the effect of MTX on multiple-dose pharmacokinetics of ASP1707, as well as safety and tolerability of coadministration of ASP1707 and MTX in patients with rheumatoid arthritis (RA).
Detailed description
Patients will check into the clinic on Day -1 and remain in the clinic until all exit procedures have been performed on the morning of Day 10.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASP1707 and methotrexate (MTX) | Experimental | Drug: ASP1707, Drug: methotrexate (MTX)On day 1 patients will receive prescribed dose of MTX. On Days 3 through 8, patients will receive ASP1707 (twice daily). On Day 9, patients will receive a single dose in the morning. A single dose of MTX will be coadministered on Day 8. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Female patient must either:
- Or, if of childbearing potential,
- Male patient and his female spouse/partner who is of childbearing potential must be using highly effective forms of contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and continue throughout the study period and for 60 days after the final study drug administration.
- Female patient must agree not to breastfeed starting at screening and throughout the study period, and for 28 days or 5 half-lives, whichever is longer, after the final study drug administration.
- Female patient must not donate ova starting at screening and throughout the study period, and for 28 days or 5 half-lives, whichever is longer, after the final study drug administration.
Key exclusion criteria (10 listed)
- Patient has a previous history of clinically significant systemic disease which might confound the results of the study or pose an additional risk in administering study drug(s) to the patient. This may include, but not be limited to, a history of drug or food allergies, uncompensated heart failure, uncontrolled diabetes mellitus, severe hepatic failure, severe pulmonary disease, or history of mental disease.
- Patient has a history of any malignancy in the past 5 years, except for adequately-treated nonmelanoma skin cancer and adequately-treated-in-situ cervical cancer.
- Patient has a positive serology test for hepatitis B surface antigen (HbsAg) or hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) 1+2 antibodies.
- Patient received any breast cancer resistance protein (BCRP) transporter inhibitors or substrates, with the exception of MTX, within 28 days or 5 half-lives, whichever is longer, prior to day 1.
- Patient with liver enzyme test abnormalities, aspartate aminotransferase (AST), alanine aminotransferase (ALT) or total bilirubin > 2 times the upper limit of normal (ULN).
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 |
|---|---|---|
| ASP1707Oral | Drug | ASP1707 and methotrexate (MTX) |
| methotrexate (MTX)Oral | Drug | ASP1707 and methotrexate (MTX) |
Primary outcome
Pharmacokinetics of methotrexate (MTX) in plasma: AUCinf
Time frame: Up to Day 8
Area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf)
Pharmacokinetics of methotrexate (MTX) in plasma: Cmax
Time frame: Up to Day 8
Maximum concentration (Cmax)
33 secondary outcomes
Pharmacokinetics of methotrexate (MTX) in plasma: AUClast
Time frame: Up to Day 8
Pharmacokinetics of methotrexate (MTX) in plasma: tmax
Time frame: Up to Day 8
Pharmacokinetics of methotrexate (MTX) in plasma: t 1/2
Time frame: Up to Day 8
Pharmacokinetics of methotrexate (MTX) in plasma: CL/F
Time frame: Up to Day 8
Pharmacokinetics of methotrexate (MTX) in plasma: Vz/F
Time frame: Up to Day 8
Pharmacokinetics of 7-hydroxymethotrexate (7-OH-MTX) in plasma: AUClast
Time frame: Up to Day 8
Pharmacokinetics of 7-hydroxymethotrexate (7-OH-MTX) in plasma: tmax
Time frame: Up to Day 8
Pharmacokinetics of 7-hydroxymethotrexate (7-OH-MTX) in plasma: t 1/2
Time frame: Up to Day 8
Pharmacokinetics of 7-hydroxymethotrexate (7-OH-MTX) in plasma: MPR
Time frame: Up to Day 8
Pharmacokinetics of methotrexate (MTX) in urine: Aelast
Time frame: Up to Day 8
Pharmacokinetics of methotrexate (MTX) in urine: Aelast%
Time frame: Up to Day 8
Pharmacokinetics of methotrexate (MTX) in urine: CLR
Time frame: Up to Day 8
Pharmacokinetics of 7-hydroxymethotrexate (7-OH-MTX) in urine: Aelast
Time frame: Up to Day 8
Pharmacokinetics of 7-hydroxymethotrexate (7-OH-MTX) in urine: Aelast%
Time frame: Up to Day 8
Pharmacokinetics of 7-hydroxymethotrexate (7-OH-MTX) in urine: CLR
Time frame: Up to Day 8
Pharmacokinetics of ASP1707 in plasma: AUCtau
Time frame: Up to Day 8
Pharmacokinetics of ASP1707 in plasma: Cmax
Time frame: Up to Day 8
Pharmacokinetics of ASP1707 in plasma: tmax
Time frame: Up to Day 8
Pharmacokinetics of ASP1707 in plasma: CL/F
Time frame: Up to Day 8
Pharmacokinetics of ASP1707 in plasma: Ctrough
Time frame: Up to Day 9
Pharmacokinetics of ASP1707 in plasma: MPR
Time frame: Up to Day 8
Pharmacokinetics of AS1948006 in plasma: AUCtau
Time frame: Up to Day 8
Pharmacokinetics of AS1948006 in plasma: Cmax
Time frame: Up to Day 8
Pharmacokinetics of AS1948006 in plasma: tmax
Time frame: Up to Day 8
Pharmacokinetics of AS1948006 in plasma: Ctrough
Time frame: Up to Day 8
Pharmacokinetics of AS1948006 in plasma: MPR
Time frame: Up to Day 8
Safety as assessed by Adverse Events (AEs)
Time frame: Up to Day 13
Safety assessed by Laboratory Test: hematology
Time frame: Up to Day 13
Safety assessed by Laboratory Test: biochemistry
Time frame: Up to Day 13
Safety assessed by Laboratory Test: serology
Time frame: Up to Day 13
Safety assessed by Laboratory Test: urinalysis
Time frame: Up to Day 13
Safety assessed by 12- lead electrocardiogram (ECG)
Time frame: Up to Day 10
Number of participants with Physical Examination abnormalities and/or adverse events
Time frame: Up to Day 10
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 23 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Senior Medical Director study director
Astellas Pharma Global Development, Inc. (APGD)
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 ASP1707 and methotrexate (MTX) in people with Rheumatoid Arthritis, run by Astellas Pharma Global Development, Inc. at 1 site in Moldova.
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 20 inclusion and 10 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 23 Oct 2024. 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 Moldova. 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 methotrexate (MTX) in plasma: AUCinf (time frame: Up to Day 8). 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 23 Oct 2024.