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NCT Number: NCT01741493

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

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 95817, Miami, Florida, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ABT-494

Drug

Oral administration of ABT-494 capsules

Placebo

Drug

Oral administration of placebo capsules

tofacitinib

Drug

Oral administration

Primary outcomes

  1. Number and percentage of participants with Adverse Events

    Time frame: From first dose up to 28 days after the last dose of study drug

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 5, 2012
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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