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NCT04332432 · ClinicalTrials.gov registry record · Phase 1
A Single-dose, Open-label, Pharmacokinetic Study of Belapectin (GR-MD-02) in Subjects With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment
A Phase 1 study of Hepatic Impairment, sponsored by Galectin Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 4
- Study locations
NCT04332432: Completed Phase 1 study of Hepatic Impairment, sponsored by Galectin Therapeutics.
NCT04332432 is a Phase 1 study of Hepatic Impairment that has completed, run by Galectin Therapeutics. The registered enrollment target is 38 participants, roughly in line with the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target. The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04332432, a Phase 1 study of Hepatic Impairment, has completed, sponsored by Galectin Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study will assess the pharmacokinetics of belapectin in subjects with mild, moderate, or severe hepatic impairment according to 3 different Child-Pugh categories: mild, moderate, or severe impairment, compared to matched healthy control subjects.
Primary Outcome
Statistical comparison of the pharmacokinetic AUC0-∞ parameters of belapectin in plasma from varying degrees of hepatic impairment to normal hepatic function following a single intravenous dose . AUC0-∞ = area under the concentration-time curve from time 0 to infinity.
Conditions Studied
Interventions
- DRUG belapectin
Study Locations (4)
Texas
- Texas Liver Institute - San Antonio
- Pinnacle Clinical Research - San Antonio
California
- Inland Empire Clinical Trials - Rialto
Florida
- Clinical Pharmacology of Miami, Inc - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2020-06-16 |
| Est. Completion | 2022-03-09 |
| Phase | Phase 1 |
What the finished NCT04332432 record still lists
NCT04332432 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, roughly in line with the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target.
The record links to 1 condition, with Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention - of which belapectin is the first listed.
NCT04332432 reports a single indexed study location in Texas, California, Florida.
Frequently Asked Questions
What is clinical trial NCT04332432 about?
NCT04332432 is a clinical study titled "A Single-dose, Open-label, Pharmacokinetic Study of Belapectin (GR-MD-02) in Subjects With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment". This study will assess the pharmacokinetics of belapectin in subjects with mild, moderate, or severe hepatic impairment according to 3 different Child-Pugh categories: mild, moderate, or severe impairment, compared to matched healthy control subjects.
What is the current status of trial NCT04332432?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2020-06-16. Estimated completion is 2022-03-09.
What conditions does trial NCT04332432 study?
This clinical trial studies the following conditions: Hepatic Impairment.
What interventions are being tested in trial NCT04332432?
The interventions under investigation include: belapectin (DRUG).
Who is sponsoring clinical trial NCT04332432?
This trial is sponsored by Galectin Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04332432 being conducted?
This trial has 4 study locations across California, Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatic Impairment
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04332432's enrollment target sits among peer trials
38 10th of 48 higher than 38 of 48 other Hepatic Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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