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

ArmDescriptionAssigned Intervention
Experimental
Period 1: Group 1 		Participants will receive multiple doses of Upadacitinib
  • Drug: Upadacitinib
    Oral
Experimental
Period 1: Group 2 		Participants will receive multiple doses of Upadacitinib
  • Drug: Upadacitinib
    Oral
Experimental
Period 2: Group 1 		Participants will receive multiple doses of ABBV-722
  • Drug: ABBV-722
    Oral
Experimental
Period 2: Group 2 		Participants will receive multiple doses of ABBV-722
  • Drug: ABBV-722
    Oral
Experimental
Period 3: Group 1 		Participants will receive multiple doses of ABBV-722 and Upadacitinib
  • Drug: ABBV-722
    Oral
  • Drug: Upadacitinib
    Oral
Experimental
Period 3: Group 2 		Participants will receive multiple doses of ABBV-722 and Upadacitinib
  • Drug: ABBV-722
    Oral
  • Drug: Upadacitinib
    Oral

Recruiting Locations

Acpru /Id# 279285
Grayslake, Illinois 60030

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com