A Study to Evaluate the Pharmacokinetics of ASP1707 and Methotrexate in Patients With Rheumatoid Arthritis

NCT02867306 | Completed Phase 1

• 2 other identifiers: 1707-CL-30022016-001192-76
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 patients with rheumatoid arthritis (RA).

Conditions

Rheumatoid Arthritis

Keywords

methotrexate (MTX); Pharmacokinetics; ASP1707; Rheumatoid Arthritis (RA)

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics of methotrexate (MTX) in plasma: AUCinf

  Area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf)

  Up to Day 8

• Pharmacokinetics of methotrexate (MTX) in plasma: Cmax

  Maximum concentration (Cmax)

  Up to Day 8

Secondary Outcomes (33)

• Pharmacokinetics of methotrexate (MTX) in plasma: AUClast

  Up to Day 8

• Pharmacokinetics of methotrexate (MTX) in plasma: tmax

  Up to Day 8

• Pharmacokinetics of methotrexate (MTX) in plasma: t 1/2

  Up to Day 8

• Pharmacokinetics of methotrexate (MTX) in plasma: CL/F

  Up to Day 8

• Pharmacokinetics of methotrexate (MTX) in plasma: Vz/F

  Up to Day 8

Study Arms (1)

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.

Drug: ASP1707; Drug: methotrexate (MTX)

Interventions

ASP1707 DRUG

Oral

ASP1707 and methotrexate (MTX)

methotrexate (MTX) DRUG

Oral

ASP1707 and methotrexate (MTX)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (1)

Site MD37301

Chisinau, MD-2025, Moldova

Location

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

opigolix; Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Senior Medical Director

  Astellas Pharma Global Development, Inc. (APGD)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 15, 2016
• Study Start: July 25, 2016
• Primary Completion: August 30, 2016
• Study Completion: August 30, 2016
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)