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Authors
Kastelein, John J. P.
Ditmarsch, Marc
Hsieh, Andrew
Kling, Douglas
Walker, Ashley
Dicklin, Mary R.
Tayab, Zia
Bouhajib, Mohammed
Davidson, Michael H.
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Clinical Trials BETA
Clinical trials referenced in this document:
nct06081166 at ClinicalTrials.govDocuments that mention this clinical trial
A Drug–Drug Interaction Study Evaluating the Pharmacokinetic Consequences of Obicetrapib Therapy on Atorvastatin or Rosuvastatin Levels in Healthy Volunteers
https://doi.org/10.1007/s40256-025-00740-1
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Funding
Funding for this research was provided by:
New Amsterdam Pharma
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Article History
Accepted: 14 May 2025
First Online: 26 June 2025
Declarations
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: This study was funded by NewAmsterdam Pharma.
: JJPK, MD, AH, DK, AW, and MHD are employees of NewAmsterdam Pharma, and they also report that they receive stock or stock options. MRD is an employee of Midwest Biomedical Research, which provides clinical trial and consulting services for various companies in the nutritional/food and pharmaceutical industries, including NewAmsterdam Pharma. ZT and MB are employees of Pharma Medical Research, Mississauga, ON, Canada.
: JJPK, MD, AH, DK, and MHD contributed to the study design. DK and AW contributed to data acquisition. MRD wrote the first draft of the manuscript. JJPK, MD, AH, MRD, ZT, and MB revised subsequent versions of the manuscript, and all authors approved the final version of the manuscript.
: The data sets generated during this study are available from the corresponding author upon reasonable request.
: The study protocol was approved by Optum Clinical Research, Inc. on September 6, 2023 (an updated version was approved on September 10, 2023, and a protocol clarification letter was acknowledged on November 8, 2023). The study was conducted in compliance with all local regulations, the Declaration of Helsinki, and the International Conference on Harmonization Guidelines for Good Clinical Practice.
: Witten consent, in compliance with local legislation and regulations, was obtained from each study participant before entering the study or performing any procedure on the individual. Each participant was provided with verbal and written information, in non-technical terms, which described the nature, duration, potential risks, and any benefits of the study. Adequate information was provided to individuals to allow them to make an informed decision about their participation. Prior to signing any consent forms, individuals were allowed sufficient time to consider the potential risks associated with their participation and were given the opportunity to ask any questions they may have had.
: Not applicable.
: Not applicable.
