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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ABT-494

Placebo

Tofacitinib

About this trial

This is an interventional other trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Methotrexate, Tolerability, Pharmacokinetics, Safety, Tofacitinib

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Site Reference ID/Investigator# 95817
Site Reference ID/Investigator# 95816
Site Reference ID/Investigator# 95815
Site Reference ID/Investigator# 92153
Site Reference ID/Investigator# 97177

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Other

Arm Label

Healthy Volunteers (ABT-494)

Rheumatoid Arthritis Patients

No treatment

Healthy Volunteers (tofa)

Arm Description

Multiple dosing of ABT-494 in healthy volunteers

Multiple dosing of ABT-494 in patients with rheumatoid arthritis

Placebo administration in healthy volunteers and patients with rheumatoid arthritis

Multiple dosing of tofacitinib in healthy volunteers

Outcomes

Primary Outcome Measures

Number and percentage of participants with Adverse Events

Vital Signs

Blood pressure, pulse rate and body temperature

Clinical Lab testing

Hematology, Chemistry, and Urinalysis

Electrocardiogram (ECG)

ECGs done in triplicate; heart rate, PR interval, QT/QTc interval and QRS duration

Pharmacokinetics of ABT-494

Cmax, Tmax, AUC, elimination rate constant and half-life

Secondary Outcome Measures

Pharmacokinetics of Methotrexate

Cmax, Tmax, AUC, elimination rate constant and half-life

Full Information

NCT ID

NCT01741493

First Posted

December 3, 2012

Last Updated

November 16, 2017

Sponsor

AbbVie (prior sponsor, Abbott)

1. Study Identification

Unique Protocol Identification Number

NCT01741493

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, Methotrexate, Tolerability, Pharmacokinetics, Safety, Tofacitinib

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy Volunteers (ABT-494)

Arm Type

Experimental

Arm Description

Multiple dosing of ABT-494 in healthy volunteers

Arm Title

Rheumatoid Arthritis Patients

Arm Type

Experimental

Arm Description

Multiple dosing of ABT-494 in patients with rheumatoid arthritis

Arm Title

No treatment

Arm Type

Placebo Comparator

Arm Description

Placebo administration in healthy volunteers and patients with rheumatoid arthritis

Arm Title

Healthy Volunteers (tofa)

Arm Type

Other

Arm Description

Multiple dosing of tofacitinib in healthy volunteers

Intervention Type

Drug

Intervention Name(s)

ABT-494

Intervention Description

Oral administration of ABT-494 capsules

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral administration of placebo capsules

Intervention Type

Drug

Intervention Name(s)

Tofacitinib

Intervention Description

Oral administration

Primary Outcome Measure Information:

Title

Number and percentage of participants with Adverse Events

Time Frame

From first dose up to 28 days after the last dose of study drug

Title

Vital Signs

Description

Blood pressure, pulse rate and body temperature

Time Frame

From first dose up to 28 days after the last dose of study drug

Title

Clinical Lab testing

Description

Hematology, Chemistry, and Urinalysis

Time Frame

From date of first dose up to 28 days after the last dose of study drug

Title

Electrocardiogram (ECG)

Description

ECGs done in triplicate; heart rate, PR interval, QT/QTc interval and QRS duration

Time Frame

Prior to first dose, during first dose interval, prior to last dose and until 24 hours post last dose

Title

Pharmacokinetics of ABT-494

Description

Cmax, Tmax, AUC, elimination rate constant and half-life

Time Frame

Prior to first dose up to 72 hours after the last dose of ABT-494

Secondary Outcome Measure Information:

Title

Pharmacokinetics of Methotrexate

Description

Cmax, Tmax, AUC, elimination rate constant and half-life

Time Frame

Prior to first dose up to 48 hours after the last dose of methotrexate

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Jungerwirth, MD

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Site Reference ID/Investigator# 95817

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Site Reference ID/Investigator# 95816

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45255

Country

United States

Facility Name

Site Reference ID/Investigator# 95815

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Site Reference ID/Investigator# 92153

City

Austin

State/Province

Texas

ZIP/Postal Code

78744

Country

United States

Facility Name

Site Reference ID/Investigator# 97177

City

Orem

State/Province

Utah

ZIP/Postal Code

84058

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27272171

Citation

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):1547-1558. doi: 10.1007/s40262-016-0419-y.

Results Reference

result

PubMed Identifier

29076110

Citation

Klunder B, Mohamed MF, Othman AA. Population Pharmacokinetics of Upadacitinib in Healthy Subjects and Subjects with Rheumatoid Arthritis: Analyses of Phase I and II Clinical Trials. Clin Pharmacokinet. 2018 Aug;57(8):977-988. doi: 10.1007/s40262-017-0605-6.

Results Reference

derived

Learn more about this trial

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

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