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 study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01741493
First received: December 3, 2012
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: ABT-494
Drug: Placebo
Drug: Tofacitinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Number and percentage of participants with Adverse Events [ Time Frame: From first dose up to 28 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
  • Vital Signs [ Time Frame: From first dose up to 28 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
    Blood pressure, pulse rate and body temperature

  • Clinical Lab testing [ Time Frame: From date of first dose up to 28 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
    Hematology, Chemistry, and Urinalysis

  • Electrocardiogram (ECG) [ Time Frame: Prior to first dose, during first dose interval, prior to last dose and until 24 hours post last dose ] [ Designated as safety issue: Yes ]
    ECGs done in triplicate; heart rate, PR interval, QT/QTc interval and QRS duration

  • Pharmacokinetics of ABT-494 [ Time Frame: Prior to first dose up to 72 hours after the last dose of ABT-494 ] [ Designated as safety issue: No ]
    Cmax, Tmax, AUC, elimination rate constant and half-life


Secondary Outcome Measures:
  • Pharmacokinetics of Methotrexate [ Time Frame: Prior to first dose up to 48 hours after the last dose of methotrexate ] [ Designated as safety issue: No ]
    Cmax, Tmax, AUC, elimination rate constant and half-life


Enrollment: 67
Study Start Date: November 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Healthy Volunteers (tofa)
Multiple dosing of tofacitinib in healthy volunteers
Drug: Tofacitinib
Oral administration

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01741493

Locations
United States, Florida
Site Reference ID/Investigator# 95817
Miami, Florida, United States, 33136
United States, Ohio
Site Reference ID/Investigator# 95816
Cincinnati, Ohio, United States, 45255
United States, Pennsylvania
Site Reference ID/Investigator# 95815
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Site Reference ID/Investigator# 92153
Austin, Texas, United States, 78744
United States, Utah
Site Reference ID/Investigator# 97177
Orem, Utah, United States, 84058
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Steven Jungerwirth, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01741493     History of Changes
Other Study ID Numbers: M13-845
Study First Received: December 3, 2012
Last Updated: January 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
Rheumatoid Arthritis
Methotrexate
Tolerability
Pharmacokinetics
Safety
Tofacitinib

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014