Status:
TERMINATED
A Study to Assess Safety of Cedirogant and How Cedirogant Moves Through the Body in Adult Participants With Mild, Moderate and Severe Hepatic Impairment
Lead Sponsor:
AbbVie
Conditions:
Hepatic Impairment
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 hepati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05376839
Start Date
July 6 2022
End Date
November 8 2022
Last Update
December 8 2022
Active Locations (3)
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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