A Study to Evaluate the Safety and Pharmacokinetics of Multiple Doses Upadacitinib, Tofacitinib, and Baricitinib in Healthy Adult Volunteers

A Phase 1 Open-label, Multiple Dose Study of Upadacitinib, Tofacitinib, and Baricitinib in Healthy Subjects to Evaluate Pharmacodynamic Biomarkers

This is a Phase 1, open label, five arm study to evaluate the pharmacodynamic effects of multiple doses of upadacitinib, tofacitinib, and baricitinib in healthy adult participants.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Upadacitinib; Drug: Tofacitinib; Drug: Baricitinib

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• United States
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Recruiting
      • Acpru /Id# 286751

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Body Mass Index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
• A condition of general good health, based upon the results of a medical history, Physical Exam (PE), vital signs, laboratory profile and a 12-lead Electrocardiogram (ECG).
• A female must not be pregnant, or breastfeeding and is not considering becoming pregnant, cryopreserving her eggs or donating eggs during the study or for approximately 30 days after the last dose of study treatment.

Exclusion Criteria:

• History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, two or more prior episodes of herpes zoster, or one or more episodes of disseminated herpes zoster, one or more prior episodes of disseminated herpes simplex (including eczema herpeticum) or any uncontrolled medical illness.
• History of any clinically significant sensitivity or allergy to any medication or food.
• History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].
• Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.
• History or evidence of active tuberculosis (TB) disease or latent TB infection.
• Participant has prior exposure to upadacitinib, tofacitinib or baricitinib within the past 90 days.
• Participant requires any over-the-counter and/or prescription medication, vitamins, and/or herbal supplements on a regular basis.
• Participant has used any medications, vitamins and/or herbal supplements within the 2-week period prior to study treatment administration.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Multiple doses of Upadacitinib; Upadacitinib will be administered once daily	Drug: Upadacitinib; Oral Tablet
Experimental: Arm 2: Multiple doses of Tofacitinib; Tofacitinib will be administered twice daily	Drug: Tofacitinib; Oral Tablet
Experimental: Arm 3: Multiple doses of Upadacitinib; Upadacitinib will be administered once daily	Drug: Upadacitinib; Oral Tablet
Experimental: Arm 4: Multiple doses of Tofacitinib; Tofacitinib will be administered twice daily	Drug: Tofacitinib; Oral Tablet
Experimental: Arm 5: Multiple doses of Baricitinib; Baricitinib will be administered once daily	Drug: Baricitinib; Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAE)	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug.	Up to 44 Days
Average plasma concentration (Cavg) of Upadacitinib	Cavg of Upadacitinib	Up to 44 Days
Average plasma concentration (Cavg) of Tofacitinib	Cavg of Tofacitinib	Up to 44 Days
Average plasma concentration (Cavg) of Baricitinib	Cavg of Baricitinib	Up to 44 Days
Area under the concentration-time curve over 24 hours (AUC24) of Upadacitinib	AUC24 of Upadacitinib	Up to 44 Days
Area under the concentration-time curve over 24 hours (AUC24) of Tofacitinib	AUC24 of Tofacitinib	Up to 44 Days
Area under the concentration-time curve over 24 hours (AUC24) of Baricitinib	AUC24 of Baricitinib	Up to 44 Days
Maximum Observed Plasma Concentration (Cmax) of Upadacitinib	Cmax of Upadacitinib	Up to 44 Days
Maximum Observed Plasma Concentration (Cmax) of Tofacitinib	Cmax of Tofacitinib	Up to 44 Days
Maximum Observed Plasma Concentration (Cmax) of Baricitinib	Cmax of Baricitinib	Up to 44 Days

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 22, 2026
• First Submitted That Met QC Criteria: September 22, 2026
• First Posted (Actual): September 28, 2026

Study Record Updates

• Last Update Posted (Actual): September 28, 2026
• Last Update Submitted That Met QC Criteria: September 22, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Healthy Volunteers
• Additional Relevant MeSH Terms: upadacitinib; baricitinib; tofacitinib
• Other Study ID Numbers: M26-625

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No