A Phase 1 Study to Evaluate the Pharmacokinetic Interaction and Safety of ABBV-722 and Upadacitinib Following Multiple Oral Doses in Healthy Adult Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- Maximum observed plasma concentration at steady state (Cmax,ss) of ABBV-722
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- 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.
Arms & Interventions
Period 3: Group 2
Participants will receive multiple doses of ABBV-722 and Upadacitinib
Intervention: ABBV-722 (Drug)
Period 3: Group 2
Participants will receive multiple doses of ABBV-722 and Upadacitinib
Intervention: Upadacitinib (Drug)
Period 3: Group 1
Participants will receive multiple doses of ABBV-722 and Upadacitinib
Intervention: Upadacitinib (Drug)
Period 2: Group 2
Participants will receive multiple doses of ABBV-722
Intervention: ABBV-722 (Drug)
Period 3: Group 1
Participants will receive multiple doses of ABBV-722 and Upadacitinib
Intervention: ABBV-722 (Drug)
Period 1: Group 1
Participants will receive multiple doses of Upadacitinib
Intervention: Upadacitinib (Drug)
Period 1: Group 2
Participants will receive multiple doses of Upadacitinib
Intervention: Upadacitinib (Drug)
Period 2: Group 1
Participants will receive multiple doses of ABBV-722
Intervention: ABBV-722 (Drug)
Outcomes
Primary Outcomes
Maximum observed plasma concentration at steady state (Cmax,ss) of ABBV-722
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Up to Day 7 in Period 1 and Up to Day 17 in Period 3
Ctrough,ss of Upadacitinib
Area under curve over the dosing interval at steady state (AUCtau,ss) of ABBV-722
Time Frame: Up to day 7 in Period 1, up to day 6 in Period 2, up to day 17 in period 3
AUCtau,ss of ABBV-722
Maximum observed plasma concentration at steady state (Cmax,ss) of ABBV-722
Time Frame: Up to day 7 in Period 1, up to day 6 in Period 2, up to day 17 in period 3
Cmax,ss of ABBV-722
Time to maximum observed plasma concentration (Tmax) of ABBV-722
Time Frame: Up to day 7 in Period 1, up to day 6 in Period 2, up to day 17 in period 3
Tmax of ABBV-722
Observed plasma concentration at the end of the dosing interval at steady state (Ctrough,ss) of ABBV-722
Time Frame: Up to day 7 in Period 1, up to day 6 in Period 2, up to day 17 in period 3
Ctrough,ss of ABBV-722
Maximum observed plasma concentration at steady state (Cmax,ss) of Upadacitinib
Time Frame: Up to day 7 in Period 1, up to day 6 in Period 2, up to day 17 in period 3
Cmax,ss of Upadacitinib
Time to maximum observed plasma concentration (Tmax) of Upadacitinib
Time Frame: Up to day 7 in Period 1, up to day 6 in Period 2, up to day 17 in period 3
Tmax of Upadacitinib
Area under curve over the dosing interval at steady state (AUCtau,ss) of Upadacitinib
Time Frame: Up to day 7 in Period 1, up to day 6 in Period 2, 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
Time Frame: Up to day 7 in Period 1, up to day 6 in Period 2, up to day 17 in period 3
Ctrough,ss of Upadacitinib
Number of Participants with Adverse Events (AEs)
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported