A Study to Investigate How JNJ-38518168 May Affect the Plasma Levels of Methotrexate in Rheumatoid Arthritis Participants

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT01450982

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effects of JNJ-38518168 on the pharmacokinetics (how the body handles a drug) of methotrexate in participants with rheumatoid arthritis.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: JNJ-38518168 / MTX	Phase 1

Detailed Description

This is an open-label (physician and participant will know the name of the assigned drug), multi-center, non-randomized, drug/drug interaction study of JNJ-38518168 in participants with rheumatoid arthritis (RA) on a stable oral methotrexate (MTX) dose (7.5-25 mg). The treatment phase will last 16 days. Participants will be housed in the clinic for dosing and study procedures from Day -1 to Day 2 and again from Day 14 to Day 16. Participants completing treatment will have a follow-up visit between Days 22 and 25. Participants who discontinue the study prematurely will complete the Day 22 to 25 follow-up procedures at the time of discontinuation or as soon as possible thereafter. The duration of participation in the study for an individual participant will be up to 7 weeks (including screening). Participant safety will be monitored. Day 1: A single oral dose of the participant's weekly methotrexate dose. Days 2-15: Weekly MTX co-administered with two 50-mg capsules of JNJ-38518168, administered daily.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Study to Investigate the Effects of JNJ-38518168 on Methotrexate Pharmacokinetics in Rheumatoid Arthritis Participants on a Stable Methotrexate Dose

Study Start Date :

Jun 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 001 JNJ-38518168 / MTX Day 1: MTX: Route=oral use single dose of participant's weekly MTX dose Days 2-15: MTX: Route=oral use single dose of participant's weekly MTX dose and of JNJ-38518168 Type=exact unit=mg number=100 form=capsule route=oral use administered daily.	Drug: JNJ-38518168 / MTX Day 1: MTX: Route=oral use, single dose of participant's weekly MTX dose

Arm

Intervention/Treatment

Experimental: 001

JNJ-38518168 / MTX Day 1: MTX: Route=oral use single dose of participant's weekly MTX dose Days 2-15: MTX: Route=oral use single dose of participant's weekly MTX dose and of JNJ-38518168 Type=exact unit=mg number=100 form=capsule route=oral use administered daily.

Drug: JNJ-38518168 / MTX

Day 1: MTX: Route=oral use, single dose of participant's weekly MTX dose

Outcome Measures

Primary Outcome Measures

Blood levels of methotrexate [Up to approximately 7 weeks]
To assess the effect of multiple doses of JNJ-38518168 on blood levels of methotrexate

Secondary Outcome Measures

Blood levels of JNJ-38518168 [Up to approximately 7 weeks]
To assess the effect of methotrexate on the blood levels of JNJ-38518168
The number of participants with adverse events [Up to approximately 7 weeks]
Clinical laboratory tests [Up to approximately 7 weeks]
Blood and urine tests
Electrocardiograms [Up to approximately 7 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Have a body mass index (BMI) between 18 and 38 kg/m2 inclusive, and a body weight between 50-110 kg, inclusive
Have a diagnosis of Rheumatoid Arthritis functional class I-III for at least 3 months prior to Screening
Have been treated with and tolerated oral MTX treatment for a minimum of 3 months prior to screening and must have been on a once-weekly stable MTX dose (taken as a single dose) (between 7.5-25 mg/week) for a minimum of 1 month
Participants may continue on stable non-steroid anti-inflammatory drugs and corticosteroid background therapy for RA or stable therapies for other conditions as prescribed by physician, provided that the doses of such therapy are stable for at least 1 month prior to screening and will remain unchanged for the entire study duration.

Exclusion Criteria:

Have current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive or uncontrolled in the study doctor's opinion
Have been treated with a monoclonal antibody for RA or have had a serious infection with 2 weeks of the study treatment period.

Contacts and Locations

Locations

	City	State	Country
1	Anniston	Alabama	United States
2	Daytona Beach	Florida	United States
3	Duncansville	Pennsylvania	United States
4	Dallas	Texas	United States

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.