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

NCT07843693 | Recruiting Phase 1 FDA Drug

• 1 other identifier: M26-625
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (5)

Arm 1: Multiple doses of Upadacitinib

EXPERIMENTAL

Upadacitinib will be administered once daily

Drug: Upadacitinib

Arm 2: Multiple doses of Tofacitinib

EXPERIMENTAL

Tofacitinib will be administered twice daily

Drug: Tofacitinib

Arm 3: Multiple doses of Upadacitinib

EXPERIMENTAL

Upadacitinib will be administered once daily

Drug: Upadacitinib

Arm 4: Multiple doses of Tofacitinib

EXPERIMENTAL

Tofacitinib will be administered twice daily

Drug: Tofacitinib

Arm 5: Multiple doses of Baricitinib

EXPERIMENTAL

Baricitinib will be administered once daily

Drug: Baricitinib

Interventions

Upadacitinib DRUG

Oral Tablet

Arm 1: Multiple doses of Upadacitinib; Arm 3: Multiple doses of Upadacitinib

Tofacitinib DRUG

Oral Tablet

Arm 2: Multiple doses of Tofacitinib; Arm 4: Multiple doses of Tofacitinib

Baricitinib DRUG

Oral Tablet

Arm 5: Multiple doses of Baricitinib

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 286751

Grayslake, Illinois, 60030, United States

RECRUITING

MeSH Terms

Interventions

upadacitinib; tofacitinib; baricitinib

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 28, 2026
• Study Start: August 26, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)