Changeflow GovPing Healthcare & Life Sciences Phase 1 VC005 PK, Renal Impairment vs Normal
Routine Notice Added Final

Phase 1 VC005 PK, Renal Impairment vs Normal

Favicon for changeflow.com ClinicalTrials.gov Studies
Detected
Email

Summary

This is a Phase I, single-dose, open-label clinical trial (NCT07551570) evaluating the pharmacokinetics and safety of a single oral dose of 25 mg VC005 tablets in participants with renal impairment compared to participants with normal renal function. The study, scheduled for April 27, 2026, plans to enroll approximately 24 participants across two cohorts under the condition of renal impairment. VC005 tablets is the investigational product under study.

“This study is a Phase I, single-dose, open-label trial designed to evaluate the pharmacokinetics and safety of a single oral dose of 25 mg VC005 tablets in participants with renal impairment compared to participants with normal renal function.”

NIH , verbatim from source
Published by NIH on changeflow.com . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

About this source

ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.

What changed

This is a new clinical trial registration on ClinicalTrials.gov for a Phase I pharmacokinetic study of VC005 tablets. The study will enroll participants with varying degrees of renal impairment and matched participants with normal renal function to evaluate how renal function affects the drug's pharmacokinetic profile after a single 25 mg oral dose. Clinical trial registrations are informational records that do not create compliance obligations. Sponsors and clinical investigators should note this trial for competitive intelligence or patient recruitment purposes.

Pharmaceutical companies developing drugs with potential renal excretion should monitor studies like this as they may inform labeling requirements for renal dosing recommendations. Clinical research organizations may find this trial relevant for capacity planning. The trial's registration provides transparency about ongoing research but does not itself impose regulatory requirements on non-sponsor parties.

Archived snapshot

Apr 27, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

Pharmacokinetics of VC005 Tablets in Subjects With Renal Impairment and Normal Renal Function

Phase 1 NCT07551570 Kind: PHASE1 Apr 27, 2026

Abstract

This study is a Phase I, single-dose, open-label trial designed to evaluate the pharmacokinetics and safety of a single oral dose of 25 mg VC005 tablets in participants with renal impairment compared to participants with normal renal function.

Conditions: Renal Impairment

Interventions: VC005 Tablets

View original document →

Get daily alerts for ClinicalTrials.gov Studies

Daily digest delivered to your inbox.

Free. Unsubscribe anytime.

About this page

What is GovPing?

Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission

What's from the agency?

Source document text, dates, docket IDs, and authority are extracted directly from NIH.

What's AI-generated?

The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.

Last updated

Classification

Agency
NIH
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Pharmaceutical companies Clinical investigators
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Pharmacokinetics study Clinical trial registration Drug safety evaluation
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Healthcare Public Health

Get alerts for this source

We'll email you when ClinicalTrials.gov Studies publishes new changes.

Free. Unsubscribe anytime.

You're subscribed!