CP-690,550 Thorough QTc Study

NCT01743677 | Completed Phase 1 Results

• 2 other identifiers: A39210282007-004492-19
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

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.

Conditions

Healthy

Keywords

TQT study; CP-690; 550

Outcome Measures

Primary Outcomes (9)

• Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 0.25 Hour Post-Dose

  Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to the beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using the QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Data is reported as Least Squares (LS) mean difference (CP-690,550 minus Placebo, baseline-adjusted).

  0.25 hour post-dose

• Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 0.5 Hour Post-Dose

  Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The QT interval was adjusted for RR interval using the QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Data is reported as LS mean difference (CP-690,550 minus Placebo, baseline-adjusted).

  0.5 hour post-dose

• Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 1 Hour Post-Dose

  Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The QT interval was adjusted for RR interval using the QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Data is reported as LS mean difference (CP-690,550 minus Placebo, baseline-adjusted).

  1 hour post-dose

• Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 2 Hours Post-Dose

  Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The QT interval was adjusted for RR interval using the QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Data is reported as LS mean difference (CP-690,550 minus Placebo, baseline-adjusted).

  2 hours post-dose

• Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 4 Hours Post-Dose

  Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The QT interval was adjusted for RR interval using the QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Data is reported as LS mean difference (CP-690,550 minus Placebo, baseline-adjusted).

  4 hours post-dose

• Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 8 Hours Post-Dose

  Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The QT interval was adjusted for RR interval using the QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Data is reported as LS mean difference (CP-690,550 minus Placebo, baseline-adjusted).

  8 hours post-dose

• Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 12 Hours Post-Dose

  Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The QT interval was adjusted for RR interval using the QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Data is reported as LS mean difference (CP-690,550 minus Placebo, baseline-adjusted).

  12 hours post-dose

• Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 16 Hours Post-Dose

  Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The QT interval was adjusted for RR interval using the QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Data is reported as LS mean difference (CP-690,550 minus Placebo, baseline-adjusted).

  16 hours post-dose

• Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 24 Hours Post-Dose

  Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The QT interval was adjusted for RR interval using the QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Data is reported as LS mean difference (CP-690,550 minus Placebo, baseline-adjusted).

  24 hours post-dose

Secondary Outcomes (12)

• Mean Time-Matched Difference in QTcF Intervals Between Moxifloxacin Compared to Placebo

  2 hours post-dose

• Mean Time-Matched Difference in QTcB Intervals Between CP-690,550 Compared to Placebo

  0.25, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours post-dose

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-690,550

  0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-690,550

  0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose

• Maximum Observed Plasma Concentration (Cmax) of CP-690,550

  0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose

Study Arms (3)

CP-690,550 100 mg

EXPERIMENTAL

Drug: CP-690,550

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Moxifloxacin hydrochloride

ACTIVE COMPARATOR

Drug: Moxifloxacin

Interventions

CP-690,550 DRUG

Single dose 100 mg (5 x 20 mg tablets)

CP-690,550 100 mg

Placebo DRUG

Single dose placebo tablets (5 tablets)

Placebo

Moxifloxacin DRUG

Single dose Avelox 400 mg tablet

Moxifloxacin hydrochloride

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Use of tobacco- or nicotine-containing products in excess of equivalent of 5 cigarettes per day.
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Pfizer Clinical Research Unit

Brussels, 1070, Belgium

Location

Pfizer Clinical Research Unit

Singapore, 188770, Singapore

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

tofacitinib; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: December 6, 2012
• Study Start: October 26, 2007
• Primary Completion: February 7, 2008
• Study Completion: February 9, 2008
• Last Updated: September 16, 2020
• Results First Posted: September 16, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); SG (1)