Pfizer Clinical Research Unit
Brussels, B-1070, Belgium
NCT Number: NCT02316756
This is first in human (FIH), double-blind, sponsor open, placebo-control trial to examine the safety, tolerability, pharmacokinetics and pharmacodynamics following a single ascending doses of PF-06648671 in healthy subjects.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Brussels, B-1070, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Experimental Pfizer compound which will be dosed as oral suspension
Placebo which will be given as oral suspension
Time frame: 0-6 weeks
Counts of participants who have TEAEs, defined as newly occuring or worsening after first dose. Relatedness to PF-06648671 will be assessed by the investigator (Yes/No). Participants with multiple occurences of an AE within a category will be counted once within the category
Time frame: 0-6 weeks
Measurement of blood pressure and pulse rate
Time frame: 0-6 weeks
Measurement of standard 12-lead ECG, single or triplicate
Time frame: 0-6 weeks
Pre-defined criteria were established for each lab test to identify potential clinical importance
Time frame: 0-72 hours post dose
Time frame: 0-72 hours post dose
Time frame: 0-72 hours post dose
Time frame: 0-72 hours post dose
Time frame: 0-72 hours post dose
Time frame: 0-72 hours post dose
Time frame: 0-72 hours post dose
Time frame: 0-72 hours post dose
Time frame: 0-72 hours post dose
Time frame: 0-72 hours post dose
Time frame: 0-72 hours post dose
Time frame: 0-72 hours post dose
Time frame: 0-72 hours post-dose
Time frame: 0-72 hours post dose
Time frame: 0-72 hours post dose
Time frame: 0-72 hours post-dose
Pfizer
Industry
A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled First-in-human Trial To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06648671 After Administration Of Single Ascending Doses To Fasted And Fed Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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