Phase 1
N=60
CP-690,550 Thorough QTc Study
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01743677 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 0.25 Hour Post-Dose — 416.48; 417.77 milliseconds (msec)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- CP-690,550 (Drug); Placebo (Drug); Moxifloxacin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 0.25 Hour Post-Dose |
416.48; 417.77 | — |
| PRIMARY Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 0.5 Hour Post-Dose |
414.70; 416.12 | — |
| PRIMARY Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 1 Hour Post-Dose |
414.69; 416.98 | — |
| PRIMARY Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 2 Hours Post-Dose |
413.70; 415.05 | — |
| PRIMARY Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 4 Hours Post-Dose |
416.83; 415.76 | — |
| PRIMARY Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 8 Hours Post-Dose |
409.25; 408.39 | — |
| PRIMARY Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 12 Hours Post-Dose |
411.39; 410.24 | — |
| PRIMARY Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 16 Hours Post-Dose |
415.87; 413.72 | — |
| PRIMARY Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 24 Hours Post-Dose |
412.53; 411.18 | — |
| SECONDARY Mean Time-Matched Difference in QTcF Intervals Between Moxifloxacin Compared to Placebo |
426.34; 415.05 | — |
| SECONDARY Mean Time-Matched Difference in QTcB Intervals Between CP-690,550 Compared to Placebo |
416.40; 416.24; 416.69; 414.91; 417.98; 414.99 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-690,550 |
2682.6 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-690,550 |
2669.7 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of CP-690,550 |
563.5 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) for CP-690,550 |
1.000 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) of CP-690,550 |
3.284 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of CP-690,550 by Cytochrome P450 2C19 (CYP2C19) Genotype |
3127.5; 2683.5; 1677.7 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-690,550 by CYP2C19 Genotype |
3114.3; 2670.2; 1673.1 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of CP-690,550 by CYP2C19 Genotype |
647.4; 565.0; 346.9 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-690,550 by CYP2C19 Genotype |
0.500; 1.000; 2.000 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) of CP-690,550 by CYP2C19 Genotype |
3.005; 3.320; 3.201 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01743677). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.