A Phase 1 Study of the Safety and How the Body Processes ABBV-722 and Upadacitinib After Multiple Oral Doses in Healthy Adult Participants

Phase 1RecruitingNCT07425899

AbbVie32 enrolled

Overview

This is a Phase 1 study to investigate safety and pharmacokinetics of ABBV-722 and Upadacitinib following multiple oral doses in healthy adult participants.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteer

Interventions

ABBV-722DRUG

Oral

UpadacitinibDRUG

Oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Acpru /Id# 279285

Grayslake, Illinois, United States

RECRUITING

Outcomes

Primary Outcomes

Maximum observed plasma concentration at steady state (Cmax,ss) of ABBV-722

Cmax,ss of ABBV-722

Time frame: Up to Day 6 in Period 2 and Up to Day 17 in Period 3

Time to maximum observed plasma concentration (Tmax) of ABBV-722

Tmax of ABBV-722

Time frame: Up to Day 6 in Period 2 and Up to Day 17 in Period 3

Area under curve over the dosing interval at steady state (AUCtau,ss) of ABBV-722

AUCtau,ss of ABBV-722

Time frame: Up to Day 6 in Period 2 and Up to Day 17 in Period 3

Observed plasma concentration at the end of the dosing interval at steady state (Ctrough,ss) of ABBV-722

Ctrough,ss of ABBV-722

Time frame: Up to Day 6 in Period 2 and Up to Day 17 in Period 3

Maximum observed plasma concentration at steady state (Cmax,ss) of Upadacitinib

Cmax,ss of Upadacitinib

Time frame: Up to Day 7 in Period 1 and Up to Day 17 in Period 3

Time to maximum observed plasma concentration (Tmax) of Upadacitinib

Tmax of Upadacitinib

Time frame: Up to Day 7 in Period 1 and Up to Day 17 in Period 3

Area under curve over the dosing interval at steady state (AUCtau,ss) of Upadacitinib

AUCtau,ss of Upadacitinib

Time frame: Up to Day 7 in Period 1 and Up to Day 17 in Period 3

Observed plasma concentration at the end of the dosing interval at steady state (Ctrough,ss) of Upadacitinib

Ctrough,ss of Upadacitinib

Central Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742 abbvieclinicaltrials@abbvie.com

Data from ClinicalTrials.gov

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