CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 60 enrolled
Drug / intervention
CP-690,550 +2 moredrug
Likely dose
CP-690,550 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01743677
NCT01743677Phase 1Completed
CompareCT.gov

A PHASE 1, RANDOMIZED, PLACEBO- AND POSITIVE-CONTROLLED CROSS-OVER STUDY TO DETERMINE THE EFFECT OF SINGLE-DOSE CP-690,550 ON QTC INTERVAL IN HEALTHY VOLUNTEERS

Pfizer·interventional·Posted Dec 6, 2012·Updated Sep 16, 2020

In Brief

A Phase 1 clinical trial evaluating CP-690,550, Placebo, and 1 other intervention for Healthy. Completed, enrolled 60 participants across 2 sites in 2 countries.

Detailed Summary

ICH E14 recommends that a thorough QT/QTc (TQT) study should be performed to determine whether intensive monitoring of QT interval in target patient populations is required during later stages of development. The current study is designed to ascertain whether CP-690,550 is associated with QTc prolongation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesBelgium, Singapore
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 6, 2012
Enrollment StartOct 26, 2007
Primary CompletionFeb 7, 2008
Study CompletionFeb 9, 2008
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 13.6 years ago

Interventions

CP-690,550drug

Single dose 100 mg (5 x 20 mg tablets)

Placebodrug

Single dose placebo tablets (5 tablets)

Moxifloxacindrug

Single dose Avelox 400 mg tablet