A Phase 1 Open-label, Multiple Dose Study of Upadacitinib, Tofacitinib, and Baricitinib in Healthy Subjects to Evaluate Pharmacodynamic Biomarkers
| Registry | NCT07843693 |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional; non randomized, parallel, masking: none, basic science |
| Enrollment | 60 (Estimated) |
| Sponsor | AbbVie (Industry) |
| Conditions | Healthy Volunteers |
| Interventions | Upadacitinib, Tofacitinib, Baricitinib (Drug) |
| Dates | start 2026-08-26, primary completion 2026-12-01 (estimated), completion 2026-12-01 (estimated), first posted 2026-09-28, last updated 2026-09-28 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Healthy Volunteers All trials of Upadacitinib All trials of Tofacitinib
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arm 1: Multiple doses of Upadacitinib | Experimental | Drug: Upadacitinib | Upadacitinib will be administered once daily |
| Arm 2: Multiple doses of Tofacitinib | Experimental | Drug: Tofacitinib | Tofacitinib will be administered twice daily |
| Arm 3: Multiple doses of Upadacitinib | Experimental | Drug: Upadacitinib | Upadacitinib will be administered once daily |
| Arm 4: Multiple doses of Tofacitinib | Experimental | Drug: Tofacitinib | Tofacitinib will be administered twice daily |
| Arm 5: Multiple doses of Baricitinib | Experimental | Drug: Baricitinib | Baricitinib will be administered once daily |
Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Acpru /Id# 286751 | Grayslake, Illinois | United States | Recruiting |