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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741493
• Other study ID #: M13-845
• Status: Completed
• Phase: Phase 1
• First received: December 3, 2012
• Last updated: November 16, 2017
• Start date: November 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• ABT-494
Oral administration of ABT-494 capsules
• Placebo
Oral administration of placebo capsules
• Tofacitinib
Oral administration

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 92153	Austin	Texas
United States	Site Reference ID/Investigator# 95816	Cincinnati	Ohio
United States	Site Reference ID/Investigator# 95815	Duncansville	Pennsylvania
United States	Site Reference ID/Investigator# 95817	Miami	Florida
United States	Site Reference ID/Investigator# 97177	Orem	Utah

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mohamed MF, Camp HS, Jiang P, Padley RJ, Asatryan A, Othman AA. Pharmacokinetics, Safety and Tolerability of ABT-494, a Novel Selective JAK 1 Inhibitor, in Healthy Volunteers and Subjects with Rheumatoid Arthritis. Clin Pharmacokinet. 2016 Dec;55(12):1547 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and percentage of participants with Adverse Events		From first dose up to 28 days after the last dose of study drug
Primary	Vital Signs	Blood pressure, pulse rate and body temperature	From first dose up to 28 days after the last dose of study drug
Primary	Clinical Lab testing	Hematology, Chemistry, and Urinalysis	From date of first dose up to 28 days after the last dose of study drug
Primary	Electrocardiogram (ECG)	ECGs done in triplicate; heart rate, PR interval, QT/QTc interval and QRS duration	Prior to first dose, during first dose interval, prior to last dose and until 24 hours post last dose
Primary	Pharmacokinetics of ABT-494	Cmax, Tmax, AUC, elimination rate constant and half-life	Prior to first dose up to 72 hours after the last dose of ABT-494
Secondary	Pharmacokinetics of Methotrexate	Cmax, Tmax, AUC, elimination rate constant and half-life	Prior to first dose up to 48 hours after the last dose of methotrexate