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

Phase 1

Terminated

• Conditions: Hepatic Impairment
• Interventions: Drug: Cedirogant

• Registration Number: NCT05376839
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-13
• Study First Submitted QC: 2022-05-13
• Study First Posted: 2022-05-17
• Study Start: 2022-07-06
• Primary Completion: 2022-11-08
• Study Completion: 2022-11-08
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-07
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group 3: Cedirogant	Cedirogant	Participants will receive cedirogant once daily.
Group 2: Cedirogant	Cedirogant	Participants will receive cedirogant once daily.
Group 1: Cedirogant	Cedirogant	Participants will receive cedirogant once daily.
Group 4: Cedirogant	Cedirogant	Participants will receive cedirogant once daily.

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours after dosing (AUC0-24)	Up to 18 Days	AUC from time 0 to 24 hours after dosing
Time to maximum observed plasma concentration (Tmax)	Up to 18 Days	Time to maximum observed plasma concentration
Maximum Observed Plasma Concentration (Cmax)	Up to 18 Days	Maximum Observed Plasma Concentration

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	Up to 44 Days	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.

Trial Locations

Locations (3)

Clinical Pharmacology of Miami /ID# 246573; 🇺🇸 Miami, Florida, United States

Orlando Clinical Research Ctr /ID# 246052; 🇺🇸 Orlando, Florida, United States

TX Liver Inst, Americ Res Corp /ID# 246572; 🇺🇸 San Antonio, Texas, United States