Recruiting
Phase 1

Upadacitinib, Tofacitinib, Baricitinib

Sponsor:

AbbVie

Code:

NCT07843693

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Upadacitinib

Tofacitinib

Baricitinib

Study Details

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

Study ID

NCT07843693

Start date

Aug 26, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Arm 1: Multiple doses of Upadacitinib

Upadacitinib will be administered once daily

experimental: Arm 2: Multiple doses of Tofacitinib

Tofacitinib will be administered twice daily

experimental: Arm 3: Multiple doses of Upadacitinib

Upadacitinib will be administered once daily

experimental: Arm 4: Multiple doses of Tofacitinib

Tofacitinib will be administered twice daily

experimental: Arm 5: Multiple doses of Baricitinib

Baricitinib will be administered once daily

Interventions

Upadacitinib

Oral Tablet

Tofacitinib

Oral Tablet

Baricitinib

Oral Tablet

Primary outcome measure

  • Number of Participants With Treatment Emergent Adverse Events (TEAE) [ Time Frame: Up to 44 Days ]
  • Average plasma concentration (Cavg) of Upadacitinib [ Time Frame: Up to 44 Days ]
  • Average plasma concentration (Cavg) of Tofacitinib [ Time Frame: Up to 44 Days ]
  • Average plasma concentration (Cavg) of Baricitinib [ Time Frame: Up to 44 Days ]
  • Area under the concentration-time curve over 24 hours (AUC24) of Upadacitinib [ Time Frame: Up to 44 Days ]
  • Area under the concentration-time curve over 24 hours (AUC24) of Tofacitinib [ Time Frame: Up to 44 Days ]
  • Area under the concentration-time curve over 24 hours (AUC24) of Baricitinib [ Time Frame: Up to 44 Days ]
  • Maximum Observed Plasma Concentration (Cmax) of Upadacitinib [ Time Frame: Up to 44 Days ]
  • Maximum Observed Plasma Concentration (Cmax) of Tofacitinib [ Time Frame: Up to 44 Days ]
  • Maximum Observed Plasma Concentration (Cmax) of Baricitinib [ Time Frame: Up to 44 Days ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Acpru /Id# 286751

Recruiting

Grayslake, Illinois, United States, 60030

More Information

Sponsor

AbbVie

Last update posted

Sep 28, 2026

Last verified

Sep, 2026

Keywords

  • Healthy Volunteers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by AbbVie on 2026-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.