CP-690,550 Thorough QTc Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01743677
First received: October 25, 2012
Last updated: December 4, 2012
Last verified: December 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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:
Tofacitinib
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014