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NCT01812538 · ClinicalTrials.gov registry record · Phase 1
A Randomized, Single-Dose, Comparative, Positive and Placebo Controlled, Four-Way, Four Period, Cross-Over Study to Evaluate the Effect of DIC075V on QTc Intervals in Healthy Subjects
A Phase 1 study of Ventricular Repolarization, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT01812538: Completed Phase 1 study of Ventricular Repolarization, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
NCT01812538 is a Phase 1 study of Ventricular Repolarization that has completed, run by Hospira, now a wholly owned subsidiary of Pfizer. The registered enrollment target is 70 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01812538, a Phase 1 study of Ventricular Repolarization, has completed, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is conducted to evaluate the effectiveness of DIC075V on ventricular repolarization in healthy subjects compared to placebo after a single dose of DIC075V administered intravenously (IV) and to evaluate ECG assay sensitivity by evaluating the baseline-adjusted effect of a single oral (PO) moxifloxacin 400 mg dose on ventricular repolarization in healthy subjects compared to placebo. Other secondary objectives are as follows: * To evaluate the effect of DIC075V on ventricular repolarization in healthy subjects compared to placebo at the Tmax of diclofenac and hydroxypropyl-β-cyclodextrin (HPβCD). * To determine if there is a pharmacokinetic/pharmacodynamic (PK/PD) relationship between the duration of the QTc intervals and diclofenac and HPβCD plasma concentrations. * Obtain additional pharmacokinetic (PK) information on diclofenac and HPβCD in healthy subjects. * Provide additional safety information.
Primary Outcome
The primary ECG endpoint is the time-matched active drug-placebo difference in baseline-adjusted QTc interval using the Fridericia correction formula (QTcF). The QTcF is evaluated at the time point where the maximal baseline and placebo-adjusted value is observed. These measurements are consistent with ICH E14 guidance.
Conditions Studied
Interventions
- DRUG DIC075V
Study Locations (1)
North Dakota
- Cetero Research - Fargo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2009-05 |
| Est. Completion | 2009-07 |
| Phase | Phase 1 |
What the finished NCT01812538 record still lists
NCT01812538 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher).
The record links to 1 condition, with Ventricular Repolarization appearing as the primary indexed condition, and to 1 intervention - of which DIC075V is the first listed.
NCT01812538 reports a single indexed study location in North Dakota.
Frequently Asked Questions
What is clinical trial NCT01812538 about?
NCT01812538 is a clinical study titled "A Randomized, Single-Dose, Comparative, Positive and Placebo Controlled, Four-Way, Four Period, Cross-Over Study to Evaluate the Effect of DIC075V on QTc Intervals in Healthy Subjects". This study is conducted to evaluate the effectiveness of DIC075V on ventricular repolarization in healthy subjects compared to placebo after a single dose of DIC075V administered intravenously (IV) and to evaluate ECG assay sensitivity by evaluating the baseline-adjusted effect of a single oral (PO)...
What is the current status of trial NCT01812538?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2009-05. Estimated completion is 2009-07.
What conditions does trial NCT01812538 study?
This clinical trial studies the following conditions: Ventricular Repolarization.
What interventions are being tested in trial NCT01812538?
The interventions under investigation include: DIC075V (DRUG).
Who is sponsoring clinical trial NCT01812538?
This trial is sponsored by Hospira, now a wholly owned subsidiary of Pfizer, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01812538 being conducted?
This trial has 1 study location across North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01812538's enrollment target sits among peer trials
70 749th of 2000 higher than 1,227 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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