CP-690,550 Thorough QTc Study

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01743677
• Date of registration: 25/10/2012
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: CP-690,550 Thorough QTc Study
• Scientific 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
• Date of first enrolment: October 26, 2007
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01743677
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Belgium, Singapore

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Moxifloxacin

Drug: CP-690,550

Drug: Placebo

Primary Outcome(s)

Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 1 Hour Post-Dose [Time Frame: 1 hour post-dose]

Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 0.25 Hour Post-Dose [Time Frame: 0.25 hour post-dose]

Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 16 Hours Post-Dose [Time Frame: 16 hours post-dose]

Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 2 Hours Post-Dose [Time Frame: 2 hours post-dose]

Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 4 Hours Post-Dose [Time Frame: 4 hours post-dose]

Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 0.5 Hour Post-Dose [Time Frame: 0.5 hour post-dose]

Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 12 Hours Post-Dose [Time Frame: 12 hours post-dose]

Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 24 Hours Post-Dose [Time Frame: 24 hours post-dose]

Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 8 Hours Post-Dose [Time Frame: 8 hours post-dose]

Secondary Outcome(s)

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-690,550 by CYP2C19 Genotype [Time Frame: 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 by CYP2C19 Genotype [Time Frame: 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 Extrapolated Infinite Time [AUC (0 - 8)] of CP-690,550 by Cytochrome P450 2C19 (CYP2C19) Genotype [Time Frame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose]

Mean Time-Matched Difference in QTcB Intervals Between CP-690,550 Compared to Placebo [Time Frame: 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 - 8)] for CP-690,550 [Time Frame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose]

Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-690,550 by CYP2C19 Genotype [Time Frame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose]

Mean Time-Matched Difference in QTcF Intervals Between Moxifloxacin Compared to Placebo [Time Frame: 2 hours post-dose]

Maximum Observed Plasma Concentration (Cmax) of CP-690,550 [Time Frame: 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 [Time Frame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose]

Plasma Decay Half-Life (t1/2) of CP-690,550 [Time Frame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose]

Plasma Decay Half-Life (t1/2) of CP-690,550 by CYP2C19 Genotype [Time Frame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose]

Time to Reach Maximum Observed Plasma Concentration (Tmax) for CP-690,550 [Time Frame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose]

Secondary ID(s)

2007-004492-19

A3921028

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/09/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01743677