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This is a Phase 1 study to investigate safety and pharmacokinetics of ABBV-722 and Upadacitinib following multiple oral doses in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1: Group 1 | Experimental | Participants will receive multiple doses of Upadacitinib |
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| Period 1: Group 2 | Experimental | Participants will receive multiple doses of Upadacitinib |
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| Period 2: Group 1 | Experimental | Participants will receive multiple doses of ABBV-722 |
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| Period 2: Group 2 | Experimental | Participants will receive multiple doses of ABBV-722 |
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| Period 3: Group 1 | Experimental | Participants will receive multiple doses of ABBV-722 and Upadacitinib |
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| Period 3: Group 2 | Experimental | Participants will receive multiple doses of ABBV-722 and Upadacitinib |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-722 | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration at steady state (Cmax,ss) of ABBV-722 | Cmax,ss of ABBV-722 | 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 | 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 | 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 | 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 | 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 | 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 | Up to Day 7 in Period 1 and Up to Day 17 in Period 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acpru /Id# 279285 | Recruiting | Grayslake | Illinois | 60030 | United States |
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| ID | Term |
|---|---|
| C000613732 | upadacitinib |
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| Upadacitinib | Drug | Oral |
|
| Observed plasma concentration at the end of the dosing interval at steady state (Ctrough,ss) of Upadacitinib | Ctrough,ss of Upadacitinib | Up to Day 7 in Period 1 and Up to Day 17 in Period 3 |
| Number of Participants with Adverse Events (AEs) | 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. | Approximately up to 91 days |