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
Coimbra, Jimena (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Llorens, Marta (Oxolife, S.L. (Barcelona))
Torres Blanch, Rosa (Oxolife, S.L. (Barcelona))
Antonijoan Arbós, Rosa Ma (Rosa María) (Institut de Recerca Sant Pau)
Calaf Alsina, Joaquim (Institut de Recerca Sant Pau)
Arbat, Agnès (Universidad CEU San Pablo)
Canals, Ignasi (Oxolife, S.L. (Barcelona))
Molina Perelló, Pol (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Moral-Blanch, Marta (Oxolife, S.L. (Barcelona))
Universitat Autònoma de Barcelona. Departament de Medicina

Data:	2025
Resum:	Phase I study to assess the effects of single oral doses of 100, 200, and 300 mg/day of sodium tungstate (OXO-001) in healthy women of childbearing age. A randomized, double-blind, dose-finding, and placebo-controlled phase I study was conducted in healthy weight (body mass index [BMI] 18. 5-24. 9 kg/m2) and overweight (BMI 25 to ≥30 kg/m2) volunteers who received OXO-001 or placebo during a menstrual cycle (maximum 28 days). Data recorded were adverse events (AEs), vital signs, electrocardiogram (ECG), laboratory tests, pharmacokinetics (PK) parameters, and transvaginal ultrasound. Thirty women were included in the safety analysis, and 29 completed the study. Thirty-eight treatment emergent adverse events (TEAEs) were reported by 20 participants (15 in the OXO-001 group and 5 in the placebo group). TEAEs were related to OXO-001 administration in 13. 2, 10. 5, and 15. 8% of cases of the 100, 200, and 300 mg doses, respectively. None of the participants discontinued the study, and no serious AEs or deaths were recorded. Differences in TEAEs by BMI were not found. The PK profile showed a fast absorption rate and proportional increases of OXO-001 plasma concentration to increasing doses, suggesting linear PK, with higher concentrations in BMI.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Fertility ; Pharmacokinetics ; Phase I study ; Safety ; Sodium Tungstate
Publicat a:	International journal of fertility and sterility, Vol. 19 (March 2025) , p. 177-185, ISSN 2008-0778

DOI: 10.22074/ijfs.2024.2013704.1554
PMID: 40200776

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