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Cedirogant for Liver Disease

Q: Has the FDA granted authorization to Cedirogant?

<p>Cedirogant has yet to be thoroughly evaluated, so its safety rating is 1. This reflects the fact that this Phase 1 trial does not have adequate evidence for both efficacy and security.</p>

Phase 1

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 44 days

Awards & highlights

Study Summary

This trial looks at how well and how safe the drug cedirogant works in people with different levels of liver function.

Eligible Conditions

Liver Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 44 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 44 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 44 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours after dosing (AUC0-24)

Maximum Observed Plasma Concentration (Cmax)

Time to maximum observed plasma concentration (Tmax)

Secondary outcome measures

Number of Participants with Adverse Events

Trial Design

4Treatment groups

Experimental Treatment

Group I: Group 4: CedirogantExperimental Treatment1 Intervention

Participants will receive cedirogant once daily.

Group II: Group 3: CedirogantExperimental Treatment1 Intervention

Participants will receive cedirogant once daily.

Group III: Group 2: CedirogantExperimental Treatment1 Intervention

Participants will receive cedirogant once daily.

Group IV: Group 1: CedirogantExperimental Treatment1 Intervention

Participants will receive cedirogant once daily.

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AbbVieLead Sponsor

958 Previous Clinical Trials

502,378 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

397 Previous Clinical Trials

147,092 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being welcomed into this research endeavor?

"Correct. According to clinicaltrials.gov, this medical research is still actively seeking participants since it was posted on July 6th 2022, and updated most recently on September 5th 2022. 24 individuals must be recruited from 3 distinct sites for the trial to progress."

Answered by AI

Are there still opportunities for patients to participate in this experiment?

"That is correct. According to the details on clinicaltrials.gov, this research endeavour, which was initially advertised on July 6th 2022, is actively recruiting participants. A total of 24 volunteers need to be sourced from 3 different medical centres."

Answered by AI

Are there any age restrictions for participants in this research project?

"The cut-off age for this trial is 18, with the upper limit being 75."

Answered by AI

Is there an opportunity to join this trial?

"For this clinical trial, 24 individuals aged 18-75 who have a diagnosed liver condition are needed. In accordance with the protocol's requirements, each participant must possess a BMI of ≥18 to <40 kg/m2, exhibit good general health based on medical history and physical exam results, as well as 12-lead ECG readings (excluding those with hepatic impairment)."

Answered by AI

Has the FDA granted authorization to Cedirogant?

"Cedirogant has yet to be thoroughly evaluated, so its safety rating is 1. This reflects the fact that this Phase 1 trial does not have adequate evidence for both efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Study to Assess Safety of Cedirogant and How Cedirogant Moves Through the Body in Adult Participants With Mild, Moderate and Severe Hepatic Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05376839.