CP-690,550 Thorough QTc Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: CP-690,550 Drug: Placebo Drug: Moxifloxacin	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title:	A Phase 1, Randomized, Placebo- And Positive-Controlled Crossover Study To Determine The Effect Of Single-Dose CP-690,550 On QTc Interval In Healthy Volunteers

Resource links provided by NLM:

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Time-matched mean differences in QTcF intervals between CP-690,550 and placebo (baseline-adjusted) at each postdose time [ Time Frame: 0.25 hr postdose ] [ Designated as safety issue: Yes ]
Time-matched mean differences in QTcF intervals between CP-690,550 and placebo (baseline-adjusted) at each postdose time [ Time Frame: 0.5 hr postdose ] [ Designated as safety issue: Yes ]
Time-matched mean differences in QTcF intervals between CP-690,550 and placebo (baseline-adjusted) at each postdose time [ Time Frame: 1 hr postdose ] [ Designated as safety issue: Yes ]
Time-matched mean differences in QTcF intervals between CP-690,550 and placebo (baseline-adjusted) at each postdose time [ Time Frame: 2 hr postdose ] [ Designated as safety issue: Yes ]
Time-matched mean differences in QTcF intervals between CP-690,550 and placebo (baseline-adjusted) at each postdose time [ Time Frame: 4 hr postdose ] [ Designated as safety issue: Yes ]
Time-matched mean differences in QTcF intervals between CP-690,550 and placebo (baseline-adjusted) at each postdose time [ Time Frame: 8 hr postdose ] [ Designated as safety issue: Yes ]
Time-matched mean differences in QTcF intervals between CP-690,550 and placebo (baseline-adjusted) at each postdose time [ Time Frame: 12 hr postdose ] [ Designated as safety issue: Yes ]
Time-matched mean differences in QTcF intervals between CP-690,550 and placebo (baseline-adjusted) at each postdose time [ Time Frame: 16 hr postdose ] [ Designated as safety issue: Yes ]
Time-matched mean differences in QTcF intervals between CP-690,550 and placebo (baseline-adjusted) at each postdose time [ Time Frame: 24 hr postdose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Mean Time-Matched Difference in QTcF Intervals Between Moxifloxacin Compared to Placebo [ Time Frame: -1, -0.5, and 0 hrs predose and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hr postdose ] [ Designated as safety issue: Yes ]
Mean Time-Matched Difference in QTcB Intervals Between CP-690,550 Compared to Placebo [ Time Frame: -1, -0.5, and 0 hrs predose and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hr postdose ] [ Designated as safety issue: Yes ]
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(0-infinity)] [ Time Frame: predose, 0.25,0.5,1,2,4,8,12,16 and 24 hr postdose ] [ Designated as safety issue: No ]
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUClast) [ Time Frame: predose, 0.25,0.5,1,2,4,8,12,16 and 24 hr postdose ] [ Designated as safety issue: No ]
Maximum Observed Plasma Concentration (Cmax) [ Time Frame: predose, 0.25,0.5,1,2,4,8,12,16 and 24 hr postdose ] [ Designated as safety issue: No ]
Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: predose, 0.25,0.5,1,2,4,8,12,16 and 24 hr postdose ] [ Designated as safety issue: No ]
Plasma Decay Half-Life (t1/2) [ Time Frame: predose, 0.25,0.5,1,2,4,8,12,16 and 24 hr postdose ] [ Designated as safety issue: No ]
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(0-infinity)] by CYP2C19 Genotype [ Time Frame: predose, 0.25,0.5,1,2,4,8,12,16 and 24 hr postdose ] [ Designated as safety issue: No ]
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) by CYP2C19 Genotype [ Time Frame: predose, 0.25,0.5,1,2,4,8,12,16 and 24 hr postdose ] [ Designated as safety issue: No ]
Maximum Observed Plasma Concentration (Cmax) by CYP2C19 Genotype [ Time Frame: predose, 0.25,0.5,1,2,4,8,12,16 and 24 hr postdose ] [ Designated as safety issue: No ]
Time to Reach Maximum Observed Plasma Concentration (Tmax) by CYP2C19 Genotype [ Time Frame: predose, 0.25,0.5,1,2,4,8,12,16 and 24 hr postdose ] [ Designated as safety issue: No ]
Plasma Decay Half-Life (t1/2) by CYP2C19 Genotype [ Time Frame: predose, 0.25,0.5,1,2,4,8,12,16 and 24 hr postdose ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	November 2007
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CP-690,550 100 mg	Drug: CP-690,550 Single dose 100 mg (5 x 20 mg tablets)
Placebo Comparator: Placebo	Drug: Placebo Single dose placebo tablets (5 tablets)
Active Comparator: Moxifloxacin hydrochloride	Drug: Moxifloxacin Single dose Avelox 400 mg tablet

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743677

Locations

Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01743677 History of Changes
Other Study ID Numbers:	A3921028
Study First Received:	October 25, 2012
Last Updated:	December 4, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

TQT study
CP-690,550

Additional relevant MeSH terms:

Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined

Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013