A Study to Assess Safety of Cedirogant and How Cedirogant Moves Through the Body in Adult Participants With Mild, Moderate and Severe Hepatic Impairment

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of Multiple Doses of Cedirogant (ABBV-157) in Subjects With Mild, Moderate and Severe Hepatic Impairment

Conditions
-----------------
Hepatic Impairment

Intervention / Treatment
-----------------
* Drug: Cedirogant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index (BMI) is ≥ 18.0 to < 40 kg/m2 A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile (except liver function tests for subjects with hepatic impairment), and 12-lead ECG Exclusion Criteria: Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests (except liver function tests for subjects with hepatic impairment) at screening that is assessed as likely to interfere with the objectives of the trial or the safety of the subject. History or evidence of active TB or latent TB infection 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 cervix

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Cedirogant<br>Participants will receive cedirogant once daily. | Drug: Cedirogant<br>* Capsule, Oral<br>|
| Experimental: Group 2: Cedirogant<br>Participants will receive cedirogant once daily. | Drug: Cedirogant<br>* Capsule, Oral<br>|
| Experimental: Group 3: Cedirogant<br>Participants will receive cedirogant once daily. | Drug: Cedirogant<br>* Capsule, Oral<br>|
| Experimental: Group 4: Cedirogant<br>Participants will receive cedirogant once daily. | Drug: Cedirogant<br>* Capsule, Oral<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cedirogant