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

Part of paid clinical trials in Miami, Florida.

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT01741493
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • ABT-494 — DRUG
    Oral administration of ABT-494 capsules
  • Placebo — DRUG
    Oral administration of placebo capsules
  • Tofacitinib — DRUG
    Oral administration

Study Details

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.

Key Dates

Start date
Nov 30, 2012
Status verified
Jan 2014
Primary completion
Dec 31, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
67 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Healthy Volunteers (ABT-494)
    Multiple dosing of ABT-494 in healthy volunteers
  • Experimental: Rheumatoid Arthritis Patients
    Multiple dosing of ABT-494 in patients with rheumatoid arthritis
  • Placebo Comparator: No treatment
    Placebo administration in healthy volunteers and patients with rheumatoid arthritis
  • Other: Healthy Volunteers (tofa)
    Multiple dosing of tofacitinib in healthy volunteers

Primary Outcome Measure

Number and percentage of participants with Adverse Events [ Time Frame: From first dose up to 28 days after the last dose of study drug ]

Locations (5)

FacilityCityStateZIPSite coordinators
Site Reference ID/Investigator# 95817MiamiFlorida33136-
Site Reference ID/Investigator# 95816CincinnatiOhio45255-
Site Reference ID/Investigator# 95815DuncansvillePennsylvania16635-
Site Reference ID/Investigator# 92153AustinTexas78744-
Site Reference ID/Investigator# 97177OremUtah84058-

Find similar trials in Miami, FL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Site Reference ID/Investigator# 95817· Miami, FLSite Reference ID/Investigator# 95816· Cincinnati, OHSite Reference ID/Investigator# 95815· Duncansville, PASite Reference ID/Investigator# 92153· Austin, TXSite Reference ID/Investigator# 97177· Orem, UT

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