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

AbbVie

Status and phase: Terminated; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: Cedirogant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05376839

M23-367

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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6 participants in 4 patient groups

Group 1: Cedirogant

Experimental group

Description:

Participants will receive cedirogant once daily.

Treatment:

Drug: Cedirogant

Group 2: Cedirogant

Experimental group

Description:

Participants will receive cedirogant once daily.

Treatment:

Drug: Cedirogant

Group 3: Cedirogant

Experimental group

Description:

Participants will receive cedirogant once daily.

Treatment:

Drug: Cedirogant

Group 4: Cedirogant

Experimental group

Description:

Participants will receive cedirogant once daily.

Treatment:

Drug: Cedirogant