Clinical trial NCT01743677: CP-690,550 Thorough QTc Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: TQT study
CP-690
550
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-12-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Detailed description: The current study is designed to ascertain whether CP-690,550 is associated with QTc prolongation

Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Use of tobacco- or nicotine-containing products in excess of equivalent of 5 cigarettes per day.
* 12-lead ECG demonstrating QTc \>450 msec or other clinically significant abnormalities at Screening.
* History of risk factors for QT prolongation or torsades de pointes.
* Pregnant or nursing women; women of childbearing potential unwilling or unable to use an acceptable method of nonhormonal contraception from at least 14 days prior to first dose until completion of follow-up.
* Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to first dose of trial medication.
* Any clinically significant infections within past 3 months or evidence of infection in past 7 days.

Primary outcomes:
measure: Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 0.25 Hour Post-Dose
timeFrame: 0.25 hour post-dose
measure: Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 0.5 Hour Post-Dose
timeFrame: 0.5 hour post-dose
measure: Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 1 Hour Post-Dose
timeFrame: 1 hour post-dose
measure: Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 2 Hours Post-Dose
timeFrame: 2 hours post-dose
measure: Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 4 Hours Post-Dose
timeFrame: 4 hours post-dose
measure: Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 8 Hours Post-Dose
timeFrame: 8 hours post-dose
measure: Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 12 Hours Post-Dose
timeFrame: 12 hours post-dose
measure: Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 16 Hours Post-Dose
timeFrame: 16 hours post-dose
measure: Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 24 Hours Post-Dose
timeFrame: 24 hours post-dose
Secondary outcomes:
measure: Mean Time-Matched Difference in QTcF Intervals Between Moxifloxacin Compared to Placebo
timeFrame: 2 hours post-dose
measure: Mean Time-Matched Difference in QTcB Intervals Between CP-690,550 Compared to Placebo
timeFrame: 0.25, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours post-dose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-690,550
timeFrame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-690,550
timeFrame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose
measure: Maximum Observed Plasma Concentration (Cmax) of CP-690,550
timeFrame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) for CP-690,550
timeFrame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose
measure: Plasma Decay Half-Life (t1/2) of CP-690,550
timeFrame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of CP-690,550 by Cytochrome P450 2C19 (CYP2C19) Genotype
timeFrame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-690,550 by CYP2C19 Genotype
timeFrame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose
measure: Maximum Observed Plasma Concentration (Cmax) of CP-690,550 by CYP2C19 Genotype
timeFrame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-690,550 by CYP2C19 Genotype
timeFrame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose
measure: Plasma Decay Half-Life (t1/2) of CP-690,550 by CYP2C19 Genotype
timeFrame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Clinical Research Unit
city: Singapore
country: Singapore
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: