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NCT01214993 · ClinicalTrials.gov registry record · Phase 1

A Phase 1, Open Label, Placebo-Controlled Study to Evaluate the Effect of GSK1349572 on Iohexol and Para-Aminohippurate Clearance in Healthy Subjects

A Phase 1 study, sponsored by ViiV Healthcare.

Completed
Registry status
Phase 1
Development phase
38
Enrollment target

NCT01214993: Completed Phase 1 study, sponsored by ViiV Healthcare.

NCT01214993 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01214993, a Phase 1 study, has completed, sponsored by ViiV Healthcare.

COMPLETED
Registry status
Phase 1
Development phase
38 participants
Enrollment target

Study Summary

The current study is designed to confirm the mechanism behind the increase in serum creatinine observed during GSK1349572 therapy; specifically, the study will determine whether GSK1349572 has any effect on glomerular filtration rate (GFR) or effective renal plasma flow. Absent such effects, one may conclude that the small increases in serum creatinine observed are due to the inhibition of the tubular secretion of creatinine via organic cation transporter 2 (OCT2) consistent with in vitro data. .

Interventions

  • DRUG Placebo
  • DRUG GSK1349572
  • DRUG Iohexol Injection
  • DRUG Para-aminohippurate infusion

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2010-10
Est. Completion 2010-11
Phase Phase 1
ViiV Healthcare

182 total trials

What the finished NCT01214993 record still lists

NCT01214993 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT01214993 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01214993 about?

NCT01214993 is a clinical study titled "A Phase 1, Open Label, Placebo-Controlled Study to Evaluate the Effect of GSK1349572 on Iohexol and Para-Aminohippurate Clearance in Healthy Subjects". The current study is designed to confirm the mechanism behind the increase in serum creatinine observed during GSK1349572 therapy; specifically, the study will determine whether GSK1349572 has any effect on glomerular filtration rate (GFR) or effective renal plasma flow. Absent such effects, one may...

What is the current status of trial NCT01214993?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2010-10. Estimated completion is 2010-11.

What interventions are being tested in trial NCT01214993?

The interventions under investigation include: Placebo (DRUG), GSK1349572 (DRUG), Iohexol Injection (DRUG), Para-aminohippurate infusion (DRUG).

Who is sponsoring clinical trial NCT01214993?

This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01214993's enrollment target sits among peer trials

38 1197th of 2000 higher than 797 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01214993, the US trial registry maintained by the National Library of Medicine. NCT01214993 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.