Not provided
Not provided
Not provided
Not provided
Not provided
Strategic considerations
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the pharmacokinetics and safety of cedirogant following oral administration of multiple doses in adult participants with hepatic impairment and normal hepatic function.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Cedirogant | Experimental | Participants will receive cedirogant once daily. |
|
| Group 2: Cedirogant | Experimental | Participants will receive cedirogant once daily. |
|
| Group 3: Cedirogant | Experimental | Participants will receive cedirogant once daily. |
|
| Group 4: Cedirogant | Experimental | Participants will receive cedirogant once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cedirogant | Drug | Capsule, Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Maximum Observed Plasma Concentration | Up to 18 Days |
| Time to maximum observed plasma concentration (Tmax) | Time to maximum observed plasma concentration | Up to 18 Days |
| Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours after dosing (AUC0-24) | AUC from time 0 to 24 hours after dosing | Up to 18 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug. | Up to 44 Days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami /ID# 246573 | Miami | Florida | 33014 | United States | ||
| Orlando Clinical Research Ctr /ID# 246052 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Orlando |
| Florida |
| 32809 |
| United States |
| TX Liver Inst, Americ Res Corp /ID# 246572 | San Antonio | Texas | 78215 | United States |