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

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: ABT-494; Drug: Placebo; Drug: Tofacitinib

• Registration Number: NCT01741493
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-12-03
• Study First Submitted QC: 2012-12-03
• Study First Posted: 2012-12-05
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2017-11-16
• Last Update Posted: 2017-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rheumatoid Arthritis Patients	ABT-494	Multiple dosing of ABT-494 in patients with rheumatoid arthritis
No treatment	Placebo	Placebo administration in healthy volunteers and patients with rheumatoid arthritis
Healthy Volunteers (ABT-494)	ABT-494	Multiple dosing of ABT-494 in healthy volunteers
Healthy Volunteers (tofa)	Tofacitinib	Multiple dosing of tofacitinib in healthy volunteers

Primary Outcome Measures

Name	Time	Method
Number and percentage of participants with Adverse Events	From first dose up to 28 days after the last dose of study drug
Pharmacokinetics of ABT-494	Prior to first dose up to 72 hours after the last dose of ABT-494	Cmax, Tmax, AUC, elimination rate constant and half-life
Vital Signs	From first dose up to 28 days after the last dose of study drug	Blood pressure, pulse rate and body temperature
Electrocardiogram (ECG)	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
Clinical Lab testing	From date of first dose up to 28 days after the last dose of study drug	Hematology, Chemistry, and Urinalysis

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of Methotrexate	Prior to first dose up to 48 hours after the last dose of methotrexate	Cmax, Tmax, AUC, elimination rate constant and half-life

Trial Locations

Locations (5)

Site Reference ID/Investigator# 95815; 🇺🇸 Duncansville, Pennsylvania, United States

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

Site Reference ID/Investigator# 95816; 🇺🇸 Cincinnati, Ohio, United States

Site Reference ID/Investigator# 97177; 🇺🇸 Orem, Utah, United States

Site Reference ID/Investigator# 92153; 🇺🇸 Austin, Texas, United States