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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 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. The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01812538
The ClinicalTrials.gov registry entry for NCT01812538 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospira, now a wholly owned subsidiary of Pfizer, which has 15 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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