Safety, Tolerability and Pharmacokinetics of Sodium Tungstate (OXO-001) in Healthy Female Volunteers of Childbearing Age: A Randomized, Double-Blind, Dose-Finding, and Placebo-Controlled Phase I Study.
The administration of OXO-001 in volunteers of childbearing age was safe and well tolerated, with consistent PK linear profile within doses studied and without detrimental effect on endometrium or ovary-related variables, with similar effects in healthy weight and overweight participants. The maximum studied dose (300 mg/ day) was safe and well tolerated. These data are sufficient to support further clinical trials (registration number: 2016-001276-30).
Authors
- Ignasi Canals (ORCID: https://orcid.org/0000-0002-3910-3897)
- Jimena Coimbra
- Pol Molina (ORCID: https://orcid.org/0000-0001-8127-7826)
- Joaquím Calaf (ORCID: https://orcid.org/0000-0002-2407-7884)
- Marta Moral-Blanch
- Rosa María Antonijoan
- Rosa J. Torres (ORCID: https://orcid.org/0000-0003-4438-8900)
- Agnès Arbat (ORCID: https://orcid.org/0009-0001-5322-9234)
- Marta Llorens (ORCID: https://orcid.org/0000-0001-8532-0115)
- Josep Perelló
Institutions
- Universidad San Pablo CEU (ES)
- Universitat Autònoma de Barcelona (ES)
- Hospital de Sant Pau (ES)
Publication Details
- Journal
- PubMed
- Published
- 2025-03-11
- DOI
- https://doi.org/10.22074/ijfs.2024.2013704.1554
- Primary Topic
- Electrolyte and hormonal disorders
- Type
- article
- Field-Weighted Citation Impact
- 0.00