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Completed Phase 1 Interventional Accepts healthy volunteers

Safety and Pharmacokinetics of CMX001 in Impaired Hepatic Function and Healthy Subjects

ClinicalTrials.gov ID: NCT05391724

Public ClinicalTrials.gov record NCT05391724. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 11:21 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-Label Study to Determine the Safety and Pharmacokinetics of CMX001 in Subjects With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is an open-label, non-randomized, multi-center, sequential group, safety, tolerance, and Pharmacokinetic study of a single dose of CMX001 administered at 2 mg/kg of ideal body weight rounded to the closest 20 mg in fasted healthy control subjects compared with that in fasted subjects with moderate and severe hepatic impairment.

Study identification

NCT ID
NCT05391724
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Jazz Pharmaceuticals
Industry
Enrollment
25 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 2011
Primary completion
Aug 31, 2011
Completion
Aug 31, 2011
Last update posted
May 25, 2022

2011

United States locations

U.S. sites
3
U.S. states
2
U.S. cities
3
Facility City State ZIP Site status
Elite Research Miami Florida 33169
Orlando Clinical Research Center Orlando Florida 32809
DaVita Clinical Research Minneapolis Minnesota 55404

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05391724, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 25, 2022 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05391724 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →