A Phase 1 Study of the Safety and How the Body Processes ABBV-722 and Upadacitinib After Multiple Oral Doses in Healthy Adult Participants
Purpose
This is a Phase 1 study to investigate safety and pharmacokinetics of ABBV-722 and Upadacitinib following multiple oral doses in healthy adult participants.
Condition
- Healthy Volunteer
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Laboratory values meet the criteria specified in the protocol. - A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
Exclusion Criteria
- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug. - Chronic recurring infection and/or active viral infection. - Consumption of alcohol, grapefruit products, Seville oranges, starfruit products or quinine/tonic water within the 72-hour period prior to study drug administration. - Use of tobacco or nicotine-containing products within 90 days prior to the first dose of study drug. - 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 - Prior exposure to ABBV-722 within 90 days prior to the first dose of study drug.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Period 1: Group 1 |
Participants will receive multiple doses of Upadacitinib |
|
|
Experimental Period 1: Group 2 |
Participants will receive multiple doses of Upadacitinib |
|
|
Experimental Period 2: Group 1 |
Participants will receive multiple doses of ABBV-722 |
|
|
Experimental Period 2: Group 2 |
Participants will receive multiple doses of ABBV-722 |
|
|
Experimental Period 3: Group 1 |
Participants will receive multiple doses of ABBV-722 and Upadacitinib |
|
|
Experimental Period 3: Group 2 |
Participants will receive multiple doses of ABBV-722 and Upadacitinib |
|
Recruiting Locations
Acpru /Id# 279285
Grayslake, Illinois 60030
Grayslake, Illinois 60030
More Details
- Status
- Recruiting
- Sponsor
- AbbVie