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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05376839

Enrollment

Registered

2022-05-17

Start date

2022-07-06

Completion date

2022-11-08

Last updated

2022-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Impairment

Keywords

Cedirogant

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.

Interventions

DRUGCedirogant

Capsule, Oral

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Maximum Observed Plasma Concentration (Cmax)	Up to 18 Days	Maximum Observed Plasma Concentration
Time to maximum observed plasma concentration (Tmax)	Up to 18 Days	Time to maximum observed plasma concentration
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

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026