Pfizer Clinical Research Unit
Brussels, B-1070, Belgium
NCT Number: NCT03656952
A phase 1, 6-sequence, 3-period, subject- and investigator blinded and sponsor-open, crossover study in healthy volunteers to evaluate the PF-06700841 effect on QTc interval. Each subject randomized will receive placebo, PF-06700841 200 mg and moxifloxacin (open label) in one of the 6 sequences. Moxifloxacin is positive control to demonstrate the study sensitivity and PF-06700841 effect on QTc will be assessed by concentration-QT analysis
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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
a single oral dose of 200 mg PF-06700841
Placebo matching PF-06700841
a single oral dose of 400 mg moxifloxacin
Time frame: 0 to 48 hours post-dose
QTc change from baseline at geometric mean of maximum concentrations observed after single doses of 200 mg PF-06700841 and maximum concentrations expected at lower doses of 30 and 60 mg.
Time frame: 0-48 hours post-dose
QTc change from baseline at 3 hours (Tmax) after a single dose of 400 mg moxifloxacin administration
Pfizer
Industry
A PHASE 1, RANDOMIZED, PLACEBO-AND POSITIVE-CONTROLLED CROSSOVER STUDY TO DETERMINE THE EFFECT OF SINGLE-DOSE PF-06700841 ON QTC INTERVAL IN HEALTHY VOLUNTEERS
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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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