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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014