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 is currently recruiting participants.
Verified March 2013 by AbbVie
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01741493
First received: December 3, 2012
Last updated: March 29, 2013
Last verified: March 2013
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Purpose
This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study in healthy volunteers and multiple dose study in patients with rheumatoid arthritis. Approximately 76 subjects will be enrolled in this study, randomized to receive either ABT-494 or placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: ABT-494 Drug: Placebo |
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
| Estimated Enrollment: | 76 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Healthy Volunteers
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
|
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 Cytochrome P-450s and UDP-glucuronosyltransferase inhibitors or inducers within the last 30 days.
- 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
Contacts
| Contact: Renee S Heuser, BS | 847-938-5887 | renee.heuser@AbbVie.com |
| Contact: Joy M Johnson, BS | 847-936-3559 | joy.johnson@AbbVie.com |
Locations
| United States, Texas | |
| Site Reference ID/Investigator# 92153 | Recruiting |
| Austin, Texas, United States, 78744 | |
| Principal Investigator: Site Reference ID/Investigator# 92153 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Director: | Robert Padley, 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: | March 29, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AbbVie:
|
Rheumatoid Arthritis Methotrexate Tolerability Pharmacokinetics Safety |
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 May 22, 2013