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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-06

Study Completion Date

2022-11-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1: Cedirogant

Participants will receive cedirogant once daily.

Group Type EXPERIMENTAL

Cedirogant

Intervention Type DRUG

Capsule, Oral

Group 2: Cedirogant

Participants will receive cedirogant once daily.

Group Type EXPERIMENTAL

Cedirogant

Intervention Type DRUG

Capsule, Oral

Group 3: Cedirogant

Participants will receive cedirogant once daily.

Group Type EXPERIMENTAL

Cedirogant

Intervention Type DRUG

Capsule, Oral

Group 4: Cedirogant

Participants will receive cedirogant once daily.

Group Type EXPERIMENTAL

Cedirogant

Intervention Type DRUG

Capsule, Oral

Interventions

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Cedirogant

Capsule, Oral

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes