Back to resultsA Study to Assess Safety of Cedirogant and How Cedirogant Moves Through the Body in Adult Participants With Mild, Moderate and Severe Hepatic Impairment
Primary Purpose
Hepatic Impairment
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cedirogant
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Impairment focused on measuring Cedirogant
Eligibility Criteria
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
Sites / Locations
- Clinical Pharmacology of Miami /ID# 246573
- Orlando Clinical Research Ctr /ID# 246052
- TX Liver Inst, Americ Res Corp /ID# 246572
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Group 1: Cedirogant
Group 2: Cedirogant
Group 3: Cedirogant
Group 4: Cedirogant
Arm Description
Participants will receive cedirogant once daily.
Participants will receive cedirogant once daily.
Participants will receive cedirogant once daily.
Participants will receive cedirogant once daily.
Outcomes
Primary Outcome Measures
Maximum Observed Plasma Concentration (Cmax)
Maximum Observed Plasma Concentration
Time to maximum observed plasma concentration (Tmax)
Time to maximum observed plasma concentration
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05376839
Brief Title
A Study to Assess Safety of Cedirogant and How Cedirogant Moves Through the Body in Adult Participants With Mild, Moderate and Severe Hepatic Impairment
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Strategic considerations
Study Start Date
July 6, 2022 (Actual)
Primary Completion Date
November 8, 2022 (Actual)
Study Completion Date
November 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment
Keywords
Cedirogant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Cedirogant
Arm Type
Experimental
Arm Description
Participants will receive cedirogant once daily.
Arm Title
Group 2: Cedirogant
Arm Type
Experimental
Arm Description
Participants will receive cedirogant once daily.
Arm Title
Group 3: Cedirogant
Arm Type
Experimental
Arm Description
Participants will receive cedirogant once daily.
Arm Title
Group 4: Cedirogant
Arm Type
Experimental
Arm Description
Participants will receive cedirogant once daily.
Intervention Type
Drug
Intervention Name(s)
Cedirogant
Intervention Description
Capsule, Oral
Primary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax)
Description
Maximum Observed Plasma Concentration
Time Frame
Up to 18 Days
Title
Time to maximum observed plasma concentration (Tmax)
Description
Time to maximum observed plasma concentration
Time Frame
Up to 18 Days
Title
Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours after dosing (AUC0-24)
Description
AUC from time 0 to 24 hours after dosing
Time Frame
Up to 18 Days
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Description
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.
Time Frame
Up to 44 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Pharmacology of Miami /ID# 246573
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Orlando Clinical Research Ctr /ID# 246052
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
TX Liver Inst, Americ Res Corp /ID# 246572
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Assess Safety of Cedirogant and How Cedirogant Moves Through the Body in Adult Participants With Mild, Moderate and Severe Hepatic Impairment
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