Clinical trials referenced in this document:
Documents that mention this clinical trial
A Population Pharmacokinetic Analysis of PF-5190457, a Novel Ghrelin Receptor Inverse Agonist in Healthy Volunteers and in Heavy Alcohol Drinkers
https://doi.org/10.1007/s40262-020-00942-7
Documents that mention this clinical trial
A Population Pharmacokinetic Analysis of PF-5190457, a Novel Ghrelin Receptor Inverse Agonist in Healthy Volunteers and in Heavy Alcohol Drinkers
https://doi.org/10.1007/s40262-020-00942-7
Funding for this research was provided by:
National Institutes of Health (UH2/UH3-TR000963, ZIA-AA000218)
Article History
Accepted: 29 August 2020
First Online: 5 November 2020
Declarations
:
: This work was funded by the National Center for Advancing Translational Sciences grant UH2/UH3-TR000963 (principal investigators: Drs. Lorenzo Leggio and Fatemeh Akhlaghi). This work was also supported by National Institutes of Health intramural funding ZIA-AA000218 (Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology; principal investigator: Dr. Lorenzo Leggio), jointly funded by the Division of Intramural Clinical and Biological Research of the National Institute on Alcohol Abuse and Alcoholism and the Intramural Research Program of the National Institute on Drug Abuse. The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
: Enoch Cobbina, Mary R. Lee, Lorenzo Leggio, and Fatemeh Akhlaghi have no conflicts of interest that are directly relevant to the content of this article.
: Two phase I clinical studies were conducted by Pfizer in healthy volunteers. Studies were conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki, all International Conference on Harmonisation Good Clinical Practice Guidelines, and all local regulatory requirements (in particular, those affording greater protection to the safety of trial participants). Final study protocols and informed consent documents were reviewed and approved by the participating research centers and by an independent ethical committee or institutional review board. The principal investigator was required to inform the independent ethical committee or institutional review board of the study’s progress and any serious and/or unexpected adverse events. The phase Ib study in subjects with alcohol use disorder was approved by the National Institutes of Health Addictions Institutional Review Board and monitored by a data safety monitoring board.
: Written, signed, and dated informed consent was obtained from participants prior to inclusion in the study. The phase Ia study in subjects with alcohol use disorder was conducted under a federal Certificate of Confidentiality. The use of PF-5190457 in this study was under the US Food and Drug Administration Investigational New Drug 119,365.
: Not applicable.
: The NONMEM code for this study can be shared upon request.