MedTrace Logo

CP-690,550 Thorough QTc Study

NCT01743677 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-09-16

Study results available
· View outcomes & findings →

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.

Conditions

  • Healthy

Interventions

DRUG

CP-690,550

Single dose 100 mg (5 x 20 mg tablets)

DRUG

Placebo

Single dose placebo tablets (5 tablets)

DRUG

Moxifloxacin

Single dose Avelox 400 mg tablet

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-26
Primary Completion
2008-02-07
Completion
2008-02-09

Countries

  • Belgium
  • Singapore

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01743677 on ClinicalTrials.gov