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

Hepatic Impairment Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05376839
• Other study ID #: M23-367
• Status: Terminated
• Phase: Phase 1
• Start date: July 6, 2022
• Est. completion date: November 8, 2022

Study information

• Verified date: December 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: November 8, 2022
• Est. primary completion date: November 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• Cedirogant
Capsule, Oral

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

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