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DZD9008 for Liver Disease

Q: How extensive is the sample size of this research?

Affirmative. Clinicaltrials.gov reveals that this clinical trial, initially posted on October 17th 2023, is presently open for recruitment. A total of twenty participants are needed between two different medical centres.

Q: Is there any criterion that would make me a candidate for this trial?

To qualify for this research, applicants must have an existing liver condition and fall within the age groups of 18-75. At present, 20 individuals are required to complete the trial.

Q: Is this research initiative seeking consenting adults to participate?

Patients must be in the 18-75 age bracket to qualify for this study. Those younger than 18 and over 65 have 28 and 253 clinical trials, respectively, that they may want to consider instead.

Q: Is enrollment in this investigation still open?

Affirmative. According to clinicaltrials.gov, this study opened on October 17th 2023 and has been actively seeking participants since then; the last update being November 8th 2023. It is planned that only 20 patients will be recruited from two different sites.

Q: What level of risk do participants face when utilizing Healthy Subject?

Our team at Power rated Healthy Subject's safety as a 1 since this is an early Phase 1 trial, meaning there are limited data points validating its efficacy and security.

Phase 1

Recruiting

Led By Eric Lawitz, MD

Research Sponsored by Dizal (Jiangsu) Pharmaceutical Co., Ltd.

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 day 1 to day 14

Awards & highlights

Study Summary

This trial will study how a drug affects people with and without liver problems and how safe it is.

Who is the study for?

This trial is for adults aged 18-75 with liver disease who have normal levels of certain liver enzymes (ALT, AST, ALP) and bilirubin. They must weigh at least 50 kg, have a BMI between 18.0 to 40.0 kg/m2, and a resting pulse rate of ≥40 but <100 bpm without significant deviations.Check my eligibility

What is being tested?

The study is testing DZD9008's effects on people with different levels of liver function. It aims to understand how the drug moves through the body (pharmacokinetics), its safety, and how well it's tolerated compared to those with normal liver function.See study design

What are the potential side effects?

While specific side effects are not listed here, generally such trials monitor for any adverse reactions related to the drug which can range from mild symptoms like headaches or nausea to more serious issues affecting organ functions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 14 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-curve from time zero to last quantifiable concentration (AUClast)

Maximum observed plasma (peak) drug concentration [Cmax]

Secondary outcome measures

12-lead ECG results: tracings, rhythm, RR interval, PR interval, QRS width, QT interval, and QTcF

Adverse events

Apparent total body clearance (CL/F)

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Hepatic impairmentExperimental Treatment1 Intervention

Subjects with hepatic impairment

Group II: Healthy SubjectExperimental Treatment1 Intervention

Subjects with normal hepatic function

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DZD9008

2021

Completed Phase 1

~80

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Dizal (Jiangsu) Pharmaceutical Co., Ltd.Lead Sponsor

2 Previous Clinical Trials

174 Total Patients Enrolled

PPD Development, L.P.UNKNOWN

Eric Lawitz, MDPrincipal InvestigatorTexas Liver Institute

4 Previous Clinical Trials

129 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 extensive is the sample size of this research?

"Affirmative. Clinicaltrials.gov reveals that this clinical trial, initially posted on October 17th 2023, is presently open for recruitment. A total of twenty participants are needed between two different medical centres."

Answered by AI

Is there any criterion that would make me a candidate for this trial?

"To qualify for this research, applicants must have an existing liver condition and fall within the age groups of 18-75. At present, 20 individuals are required to complete the trial."

Answered by AI

Is this research initiative seeking consenting adults to participate?

"Patients must be in the 18-75 age bracket to qualify for this study. Those younger than 18 and over 65 have 28 and 253 clinical trials, respectively, that they may want to consider instead."

Answered by AI

Is enrollment in this investigation still open?

"Affirmative. According to clinicaltrials.gov, this study opened on October 17th 2023 and has been actively seeking participants since then; the last update being November 8th 2023. It is planned that only 20 patients will be recruited from two different sites."

Answered by AI

What level of risk do participants face when utilizing Healthy Subject?

"Our team at Power rated Healthy Subject's safety as a 1 since this is an early Phase 1 trial, meaning there are limited data points validating its efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DZD9008 PK Study in Hepatic Impairment Subjects

2023. "DZD9008 PK Study in Hepatic Impairment Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06084104.