Healthy Volunteer
Conditions
Keywords
Healthy Volunteer, ABBV-722, Upadacitinib
Brief summary
This is a Phase 1 study to investigate safety and pharmacokinetics of ABBV-722 and Upadacitinib following multiple oral doses in healthy adult participants.
Interventions
DRUGABBV-722
Oral
DRUGUpadacitinib
Oral
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma concentration at steady state (Cmax,ss) of ABBV-722 | Up to Day 6 in Period 2 and Up to Day 17 in Period 3 | Cmax,ss of ABBV-722 |
| Time to maximum observed plasma concentration (Tmax) of ABBV-722 | Up to Day 6 in Period 2 and Up to Day 17 in Period 3 | Tmax of ABBV-722 |
| Area under curve over the dosing interval at steady state (AUCtau,ss) of ABBV-722 | Up to Day 6 in Period 2 and Up to Day 17 in Period 3 | AUCtau,ss of ABBV-722 |
| Observed plasma concentration at the end of the dosing interval at steady state (Ctrough,ss) of ABBV-722 | Up to Day 6 in Period 2 and Up to Day 17 in Period 3 | Ctrough,ss of ABBV-722 |
| Maximum observed plasma concentration at steady state (Cmax,ss) of Upadacitinib | Up to Day 7 in Period 1 and Up to Day 17 in Period 3 | Cmax,ss of Upadacitinib |
| Time to maximum observed plasma concentration (Tmax) of Upadacitinib | Up to Day 7 in Period 1 and Up to Day 17 in Period 3 | Tmax of Upadacitinib |
| Area under curve over the dosing interval at steady state (AUCtau,ss) of Upadacitinib | Up to Day 7 in Period 1 and Up to Day 17 in Period 3 | AUCtau,ss of Upadacitinib |
| Observed plasma concentration at the end of the dosing interval at steady state (Ctrough,ss) of Upadacitinib | Up to Day 7 in Period 1 and Up to Day 17 in Period 3 | Ctrough,ss of Upadacitinib |
| Number of Participants with Adverse Events (AEs) | Approximately up to 91 days | An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. |
Countries
United States
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed