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).
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Oral
Oral
Site MD37301
Chisinau, Moldova
Pharmacokinetics of methotrexate (MTX) in plasma: AUCinf
Area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf)
Time frame: Up to Day 8
Pharmacokinetics of methotrexate (MTX) in plasma: Cmax
Maximum concentration (Cmax)
Time frame: Up to Day 8
Pharmacokinetics of methotrexate (MTX) in plasma: AUClast
Area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast)
Time frame: Up to Day 8
Pharmacokinetics of methotrexate (MTX) in plasma: tmax
Time after dosing when Cmax occurs (tmax)
Time frame: Up to Day 8
Pharmacokinetics of methotrexate (MTX) in plasma: t 1/2
Apparent terminal elimination half-life (t 1/2)
Time frame: 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)
Time frame: Up to Day 8
Pharmacokinetics of methotrexate (MTX) in plasma: Vz/F
Apparent volume of distribution during the terminal elimination phase (Vz/F)
Time frame: Up to Day 8
Pharmacokinetics of 7-hydroxymethotrexate (7-OH-MTX) in plasma: AUClast
Time frame: Up to Day 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Metabolite to parent ratio of AUC using AUC(corr) for the metabolite (corrected by molecular weight ratio of parent to metabolite) (MPR)
Time frame: 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)
Time frame: 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%)
Time frame: Up to Day 8
Pharmacokinetics of methotrexate (MTX) in urine: CLR
Renal clearance (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
Area under the concentration-time curve from the time of dosing to the start of the next dosing interval (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
Concentration immediately prior to dosing at multiple dosing (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)
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.
Time frame: Up to Day 10
Number of participants with Physical Examination abnormalities and/or adverse events
Time frame: Up to Day 10