A First In Human Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Single Rising Doses In Healthy Adult Volunteers
Completed
Pfizer
Phase 1
The purpose of this first in human (FIH) study is to investigate the safety, tolerability,
pharmacokinetics ( how the body handles the drug) and pharmacodynamics (how the drug affects
the body) of PF-04455242-01 in healthy adult volunteers.
A Study Of Kappa Opioid Receptor Occupancy Of PF-04455242, Using PET (Positron Emission Tomography)
Terminated
Pfizer
Phase 1
This is a subject blind, investigator and sponsor open, randomized study consisting of 2
parts. Up to 15 healthy subjects will be included in the study. In the first part of the
study the test retest reliability of the radiotracer [11C] PF 04767135 binding in man will be
assessed. In the second part of this study, using [11C] PF 04767135, kappa opioid receptor
occupancy (RO) will be assessed in up to three cohorts of subjects.
A Multiple Dose Study To Determine Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Healthy Adult Subjects
Completed
Pfizer
Phase 1
The goals of this study are to evaluate the safety and tolerability of multiple ascending
doses of PF-04455242 administered orally to healthy adult subjects. In addition, the plasma
and urine pharmacokinetics of multiple ascending doses of PF 04455242 administered orally to
healthy adult subjects will be evaluated. Finally, the effect of multiple-doses of
PF-04455242 on serum prolactin concentration will be explored.
Proof Of Mechanism Study To Determine Efficacy Of PF-04455242 In Blocking Spiradoline (PF-00345768) Stimulated Prolactin Release
Completed
Pfizer
Phase 1
This study will be a Proof of Mechanism (POM) study to establish evidence of central
pharmacodynamic activity for PF 04455242, and will be a parallel group, randomized, double
blind, sponsor open study conducted in healthy male subjects. Once subjects achieve steady
state of PF 04455242, they will undergo PF 00345768 (spiradoline) challenge. Data will be
analyzed to determine whether PF-04455242 blocks spiradoline induced prolactin release.
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