NCT01812538

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Hospira, now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a randomized, single-dose, comparative, positive and placebo controlled, 4 period, 4-way crossover study evaluating the effect of DIC075V on QTc intervals in healthy subjects. Two doses of DIC075V are tested and include moxifloxicin as a positive control and normal saline as the placebo arm. On 4 separate occasions separated by at least 72 hours, subjects are given single IV or oral (moxifloxicin) treatments. ECGs are acquired from a continuous Holter monitor and selected timepoints will be evaluated. These ECGs will be 15 seconds in duration and extracted in triplicate. Monitoring will continue for 24 hours with each treatment. The primary ECG endpoint is the baseline-adjusted QTc using the Fridericia correction (QTcF). Secondary endpoints include the baseline-adjusted QTc using the Bazett correction formula (QTcB). In addition, a population-specific regression model will be constructed with QT plotted against RR (the time elapsed between 2 consecutive R-waves). Finally, QT parameters are explored graphically in relation to PK variables Cmax, Tmax and AUC.

Conditions

• Ventricular Repolarization

Interventions

Type	Name	Description
DRUG	DIC075V	Four single dose treatments: * Placebo (normal saline) * Moxifloxacin (positive control) * DIC075V 37.5 mg * DIC075V 75 mg All subjects receive each of the 4 treatments.

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2013-03-18
• Last updated: 2015-07-24

Locations

1 site across 1 country: United States