A Phase 1 interventional study of PF-04965842 in HEALTHY, sponsored by Pfizer. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-02.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
The purpose of this study is to assess the pharmacokinetics, safety and tolerability of PF-04965842 after single dose and once-daily multiple-doses in Chinese healthy participants.
This is a Phase 1, open-label, single-arm, single- and multiple-dose study to assess the pharmacokinetics, safety and tolerability of PF-04965842 in Chinese healthy participants.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Following an overnight fast for at least 10 hours, participants will receive PF-04965842 oral single dose of 200 mg (2 × 100 mg tablets) on Day 1, at approximately 08:00 am plus or minus 2 hours in the morning. On Days 3 to 8, participants will receive PF-04965842 oral dose of 200 mg (2 × 100 mg tablets) QD in the morning at approximately similar clock hour as on Day 1. On Day 3 and Day 6-8, the dosing of PF-04965842 will be after collection of pre-dose blood samples (under fasted condition for at least 10 hours). On Day 8, the dosing will be under fasted condition at approximately 8:00 am plus or minus 2 hours in the morning.
Drug: PF-04965842
For this study, the investigational product is PF-04965842 (provided as 100 mg tablet). PF-04965842 100 mg tablets will be provided by Pfizer. Investigational product will be presented to the participants in individual dosing containers
Also known as: Following an overnight fast for at least 10 hours, participants will receive PF-04965842 oral single dose of 200 mg (2 × 100 mg tablets) on Day 1, at approximately 08:00 am plus or, minus 2 hours in the morning, and repeated doses on Day 3 to 8. On Day 8, the dosing will be under fasted, condition at approximately 8:00 am plus or minus 2 hours in the morning.
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
PK parameters derived from plasma PF-04965842 concentration
Time frame: The pharmacokinetic samples will be collected at 0 (within 15 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours after dosing on Day 1
Maximum Observed Plasma Concentration (Cmax)
PK parameters derived from plasma PF-04965842 concentration
Time frame: The pharmacokinetic samples will be collected at 0 (within 15 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours after dosing on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax)
PK parameters derived from plasma PF-04965842 concentration
Time frame: The pharmacokinetic samples will be collected at 0 (within 15 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours after dosing on Day 1
Area under the plasma concentration time profile from time zero to time tau
PK parameters derived from plasma PF-04965842 concentration
Time frame: The pharmacokinetic samples will be collected at 0 (within 15 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours after dosing on Day 1 and Day8
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Screening up to follow up (71 days)
Number of Participants With Clinically Significant Change From Baseline in Laboratory Tests
Clinically significant abnormal laboratory findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Time frame: Screening up to follow up (71 days)
Number of Pariticipants With Clinically Significant Change From Baseline in Vital Signs
Sitting BP will be measured with the participant's arm supported at the level of the heart, with feet flat on the floor and back supported, and recorded to the nearest mm Hg after approximately 5 minutes of rest.
Time frame: Screening up to follow up (71 days)
Number of Participants With Clinically Significant Treatment-emergent Electrocardiogram (ECG) Findings
All scheduled ECGs should be performed after the participant has rested quietly for at least 10 minutes in a supine position.
Time frame: Screening up to follow up (71 days)
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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