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Part 1: Healthy participants (matched to moderate hepatic impairment) receiving Camlipixant for Cough

Phase 1

Recruiting

Research Sponsored by GlaxoSmithKline

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 96 hours post-dose

Awards & highlights

Study Summary

"This trial aims to understand how liver problems can impact the way a medication called Camlipixant is processed in the body and its safety."

Who is the study for?

This trial is for healthy men and women, as well as those with liver disease, aged 18-75. Participants must agree to use effective contraception methods. Women of childbearing potential should not plan to donate eggs within 30 days after dosing.Check my eligibility

What is being tested?

The study is testing Camlipixant's effects on people with varying levels of liver function. It aims to understand how liver impairment affects the drug's behavior in the body and its safety profile.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones may include reactions at the site of administration, gastrointestinal issues like nausea or diarrhea, headaches, dizziness, and possible allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 96 hours post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 96 hours post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 96 hours post-dose 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 Concentration-time curve from time zero to Infinity (AUC[0 to infinity]) of Camlipixant

Maximum observed plasma concentration (Cmax) of Camlipixant

Secondary outcome measures

Apparent oral clearance (CL/F) of Camlipixant

Apparent oral volume of distribution (Vz/F) of Camlipixant

Half-life (t1/2) of Camlipixant

+3 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: Part 2:Healthy participants(matched to mild and/or severe hepatic impairment)receiving CamlipixantExperimental Treatment1 Intervention

Healthy participants(matched to mild and/or severe hepatic impairment)will receive Camlipixant

Group II: Part 2: Participants with severe hepatic impairment receiving CamlipixantExperimental Treatment1 Intervention

Participants with severe hepatic impairment will receive Camlipixant

Group III: Part 2: Participants with mild hepatic impairment receiving CamlipixantExperimental Treatment1 Intervention

Participants with mild hepatic impairment will receive Camlipixant

Group IV: Part 1: Participants with moderate hepatic impairment receiving CamlipixantExperimental Treatment1 Intervention

Participants with moderate hepatic impairment will receive Camlipixant

Group V: Part 1: Healthy participants (matched to moderate hepatic impairment) receiving CamlipixantExperimental Treatment1 Intervention

Healthy participants (matched to moderate hepatic impairment) will receive Camlipixant

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?

GlaxoSmithKlineLead Sponsor

4,755 Previous Clinical Trials

8,070,803 Total Patients Enrolled

6 Trials studying Cough

151 Patients Enrolled for Cough

Bellus Health Inc. - a GSK companyLead Sponsor

17 Previous Clinical Trials

5,306 Total Patients Enrolled

6 Trials studying Cough

2,150 Patients Enrolled for Cough

Frequently Asked Questions

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

Are there any available opportunities for patients to participate in this ongoing clinical trial?

"The current status of patient enrollment for this trial can be found on clinicaltrials.gov. The initial posting date was 1/19/2024, and the latest update occurred on 3/29/2024."

Answered by AI

Does the FDA support the use of Camlipixant in individuals with moderate hepatic impairment as described in Part 1?

"Given the preliminary nature of this Phase 1 trial concerning individuals with moderate hepatic impairment receiving Camlipixant, our team at Power has rated its safety as a 1 on the scale due to the scarcity of data supporting both safety and efficacy."

Answered by AI

Is there an age restriction for individuals above 30 to participate in this research study?

"Individuals aged between 18 and 75 are eligible to participate in this research study. Separate clinical investigations cater specifically to those under 18 or over 65 years old, with a total of 32 studies targeting the former group and 270 focusing on the latter category."

Answered by AI

What are the anticipated results that this research aims to achieve?

"The primary aim of this research trial, evaluated within approximately Up to 96 hours post-administration, is to determine the Area Under the Concentration-time curve from time zero to Infinity (AUC[0 to infinity]) of Camlipixant. Secondary goals encompass examining the Apparent oral volume of distribution (Vz/F) of Camlipixant - described as Click here for more information -, identifying any participants manifesting clinically relevant alterations in laboratory parameters, vital signs, and electrocardiogram findings through a 12-lead ECG assessment defined as Click here for more details., and calculating the Half-life (t1/2"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Camlipixant in Male and Female Healthy Participants and Participants With Hepatic Impairment Aged 18-75 Years of Age

2024. "A Study of Camlipixant in Male and Female Healthy Participants and Participants With Hepatic Impairment Aged 18-75 Years of Age". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06222892.

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