A Phase 1 interventional study of PF-06865571 Immediate release suspension and PF-06865571 Slow release MR tablets in Healthy, sponsored by Pfizer. Completed at 1 site in Belgium. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-17.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
An open-label study to understand the effect of different modified release and immediate release formulations on plasma PF-06865571 concentrations after single oral administration under fed conditions
Exclusion Criteria:
Subjects with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
Treatment
Drug: PF-06865571 Immediate release suspension · Drug: PF-06865571 Slow release MR tablets · Drug: PF-06865571 Fast release MR tablets · Drug: PF-06865571 Immediate release tablets
Suspension
Modified release tablets
Modified release tablets
Immediate release tablets
Maximum Observed Plasma Concentration (Cmax) for PF-06865571
Time frame: 0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period
Time to Reach Maximum Observed Concentration for PF-06865571
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06865571
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time frame: 0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period
Area Under the Curve From Time Zero to Extrapolated Infinite Time for PF-06865571
AUC (0-infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity).
Time frame: 0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period
Plasma Decay Half-Life (t1/2) for PF-06865571
Plasma Decay Half-Life (t1/2)
Time frame: 0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period
Number of subjects with adverse events (AEs)
Number of participants with reported adverse events
Time frame: Baseline up to 35 days after last dose
Number of subjects with laboratory tests findings of potential clinical importance
Number of participants with potentially clinically important laboratory test findings
Time frame: Baseline (Day 0) up to 48 hours after last dose of study medication
Number of subjects with electrocardiogram (ECG) findings of potential clinical importance
Number of participants with potentially clinically important ECG findings
Time frame: Baseline (Day 0) up to 48 hours after last dose of study medication
Number of subjects with vital signs findings of potential clinical importance
Number of participants with potentially clinically important vital sign measurements
Time frame: Baseline (Day 0) up to 48 hours after last dose of study medication
Plan to share: No — Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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