A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494

November 16, 2017 updated by: AbbVie (prior sponsor, Abbott)

A Study in Healthy Adult Volunteers and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability, and Pharmacokinetics After Multiple Dosing of ABT-494

This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study in healthy volunteers, multiple dose study in patients with rheumatoid arthritis and multiple dose study in healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To assess the safety, tolerability and pharmacokinetics of ABT-494 in healthy volunteers and in patients with rheumatoid arthritis.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Site Reference ID/Investigator# 95817
    • Ohio
      • Cincinnati, Ohio, United States, 45255
        • Site Reference ID/Investigator# 95816
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Site Reference ID/Investigator# 95815
    • Texas
      • Austin, Texas, United States, 78744
        • Site Reference ID/Investigator# 92153
    • Utah
      • Orem, Utah, United States, 84058
        • Site Reference ID/Investigator# 97177

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy Volunteers:

  • Male and female subjects 18 to 55 years of age, inclusive.
  • Subject is judged to be in good general health.

Rheumatoid Arthritis Patients:

  • Male and female patients 18 to 75 years of age, inclusive.
  • Subject has a diagnosis of rheumatoid arthritis for at least six months.
  • Subject has been on methotrexate therapy for at least three months and on a stable dose for at least four weeks.

Exclusion Criteria:

  • History or evidence of active or latent tuberculosis.
  • History or significant allergic reaction to any drug.
  • Use of known strong CYP3A and CYP2D6 inhibitors and CYP3A inducers within 21 days or within 5 half-lives of the respective medication, whichever is longer.
  • Current or expected need for oral intake of at least 10 mg prednisone per day or equivalent corticosteroid therapy.
  • History of acute inflammatory joint disease of different origin other than rheumatoid arthritis (rheumatoid arthritis patients).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Volunteers (ABT-494)
Multiple dosing of ABT-494 in healthy volunteers
Drug: ABT-494
Oral administration of ABT-494 capsules
Experimental: Rheumatoid Arthritis Patients
Multiple dosing of ABT-494 in patients with rheumatoid arthritis
Drug: ABT-494
Oral administration of ABT-494 capsules
Placebo Comparator: No treatment
Placebo administration in healthy volunteers and patients with rheumatoid arthritis
Drug: Placebo
Oral administration of placebo capsules
Other: Healthy Volunteers (tofa)
Multiple dosing of tofacitinib in healthy volunteers
Drug: Tofacitinib
Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and percentage of participants with Adverse Events
Time Frame: From first dose up to 28 days after the last dose of study drug
From first dose up to 28 days after the last dose of study drug
Vital Signs
Time Frame: From first dose up to 28 days after the last dose of study drug
Blood pressure, pulse rate and body temperature
From first dose up to 28 days after the last dose of study drug
Clinical Lab testing
Time Frame: From date of first dose up to 28 days after the last dose of study drug
Hematology, Chemistry, and Urinalysis
From date of first dose up to 28 days after the last dose of study drug
Electrocardiogram (ECG)
Time Frame: Prior to first dose, during first dose interval, prior to last dose and until 24 hours post last dose
ECGs done in triplicate; heart rate, PR interval, QT/QTc interval and QRS duration
Prior to first dose, during first dose interval, prior to last dose and until 24 hours post last dose
Pharmacokinetics of ABT-494
Time Frame: Prior to first dose up to 72 hours after the last dose of ABT-494
Cmax, Tmax, AUC, elimination rate constant and half-life
Prior to first dose up to 72 hours after the last dose of ABT-494

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of Methotrexate
Time Frame: Prior to first dose up to 48 hours after the last dose of methotrexate
Cmax, Tmax, AUC, elimination rate constant and half-life
Prior to first dose up to 48 hours after the last dose of methotrexate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

  • Study Director: Steven Jungerwirth, MD, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 3, 2012

First Submitted That Met QC Criteria

December 3, 2012

First Posted (Estimate)

December 5, 2012

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 16, 2017

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M13-845

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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