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

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05376839

Collaborator

(none)

Enrollment

Locations

Arms

7.5

Anticipated Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Impairment	Drug: Cedirogant	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 22, 2022

Anticipated Primary Completion Date :

Feb 4, 2023

Anticipated Study Completion Date :

Feb 4, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1: Cedirogant Participants will receive cedirogant once daily.	Drug: Cedirogant Capsule, Oral
Experimental: Group 2: Cedirogant Participants will receive cedirogant once daily.	Drug: Cedirogant Capsule, Oral
Experimental: Group 3: Cedirogant Participants will receive cedirogant once daily.	Drug: Cedirogant Capsule, Oral
Experimental: Group 4: Cedirogant Participants will receive cedirogant once daily.	Drug: Cedirogant Capsule, Oral

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Pharmacology of Miami /ID# 246573	Miami	Florida	United States	33014
2	Orlando Clinical Research Ctr /ID# 246052	Orlando	Florida	United States	32809
3	TX Liver Inst, Americ Res Corp /ID# 246572	San Antonio	Texas	United States	78215

Sponsors and Collaborators

AbbVie

Investigators

Study Director: ABBVIE INC., AbbVie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AbbVie

ClinicalTrials.gov Identifier:

NCT05376839

Other Study ID Numbers:

M23-367

First Posted:

May 17, 2022

Last Update Posted:

Jul 12, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by AbbVie

Cedirogant

Additional relevant MeSH terms:

Liver Diseases

Study Results

No Results Posted as of Jul 12, 2022