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

NCT05376839 | Terminated Phase 1 FDA Drug

• 1 other identifier: M23-367
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

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.

Conditions

Hepatic Impairment

Keywords

Cedirogant

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax)

  Maximum Observed Plasma Concentration

  Up to 18 Days

• Time to maximum observed plasma concentration (Tmax)

  Time to maximum observed plasma concentration

  Up to 18 Days

• 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 Outcomes (1)

• Number of Participants with Adverse Events

  Up to 44 Days

Study Arms (4)

Group 1: Cedirogant

EXPERIMENTAL

Participants will receive cedirogant once daily.

Drug: Cedirogant

Group 2: Cedirogant

EXPERIMENTAL

Participants will receive cedirogant once daily.

Drug: Cedirogant

Group 3: Cedirogant

EXPERIMENTAL

Participants will receive cedirogant once daily.

Drug: Cedirogant

Group 4: Cedirogant

EXPERIMENTAL

Participants will receive cedirogant once daily.

Drug: Cedirogant

Interventions

Cedirogant DRUG

Capsule, Oral

Group 1: Cedirogant; Group 2: Cedirogant; Group 3: Cedirogant; Group 4: Cedirogant

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (3)

Clinical Pharmacology of Miami /ID# 246573

Miami, Florida, 33014, United States

Location

Orlando Clinical Research Ctr /ID# 246052

Orlando, Florida, 32809, United States

Location

TX Liver Inst, Americ Res Corp /ID# 246572

San Antonio, Texas, 78215, United States

Location

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 17, 2022
• Study Start: July 6, 2022
• Primary Completion: November 8, 2022
• Study Completion: November 8, 2022
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)