Dataset Information

Oral intake of mesoporous silica is safe and well tolerated in male humans.

ABSTRACT:

Background

Precisely engineered mesoporous silica has been shown to induce weight loss in mice, but whether it is safe to use in humans have not investigated.

Objective

The aim was to determine whether oral dosing, up to 9 grams/day, of precisely engineered mesoporous silica as a food additive can be used safely in male humans.

Design

This single blinded safety study consisted of two study arms including 10 males each (18-35 years). One arm consisted of participants with normal weight and one with obesity. After a placebo run-in period, all subjects were given porous silica three times daily, with increasing dose up to 9 grams/day (Phase 1). Subjects with obesity continued the study with highest dose for additional 10 weeks (Phase 2).

Results

All participants completed Phase 1 and 90% completed Phase 2, with approximately 1% missed doses. Participants reported no abdominal discomfort, and changes in bowel habits were minor and inconsistent. The side effects observed were mild and tolerable, biomarkers did not give any safety concern, and no severe adverse events occurred.

Conclusion

Mesoporous silica intake of up to 9 grams/day can be consumed by males without any major adverse events or safety concerns.

SUBMITTER: Hagman E

PROVIDER: S-EPMC7531782 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Publications

Oral intake of mesoporous silica is safe and well tolerated in male humans.

Hagman Emilia E Elimam Amira A Kupferschmidt Natalia N Ekbom Kerstin K Rössner Stephan S Iqbal Muhammad Naeem MN Johnston Eric E Lindgren Maria M Bengtsson Tore T Danielsson Pernilla P

PloS one 20201002 10

<h4>Background</h4>Precisely engineered mesoporous silica has been shown to induce weight loss in mice, but whether it is safe to use in humans have not investigated.<h4>Objective</h4>The aim was to determine whether oral dosing, up to 9 grams/day, of precisely engineered mesoporous silica as a food additive can be used safely in male humans.<h4>Design</h4>This single blinded safety study consisted of two study arms including 10 males each (18-35 years). One arm consisted of participants with no ...[more]

PMID: 33007031

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Project description:IntroductionThere is a need for new therapies in Parkinson's disease that may help to address known limitations of current options. PF-06649751 is a novel, highly selective dopamine D1/D5 agonist targeted for Parkinson's disease treatment.MethodsThe safety, pharmacokinetics, and pharmacodynamics of PF-06649751 were assessed in single ascending dose and multiple ascending dose clinical trials in patients with Parkinson's disease. The single ascending dose study (N = 18) was a double-blind, placebo-controlled study with a three-way crossover design consisting of three treatment periods separated by 7-day study drug washout periods. PF-06649751 doses were 0.75 mg, 1.5 mg, 3 mg, 6 mg, and 9 mg. In the open-label multiple ascending dose study, eligible subjects received once-daily doses of PF-06649751 (N = 45) over 21 days, with up-titration to 5 mg, 15 mg, and 25 mg once daily. Pharmacodynamics were assessed by measuring change from baseline in the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III at different time points post dose.ResultsPF-06649751 was safe and well tolerated across studies and in all cohorts. Peak plasma concentrations were attained 1-4 h post dose across both studies, and exposure increased with increasing dose. PF-06649751 demonstrated sustained pharmacodynamic effects compared with placebo, with mean reductions from baseline in the MDS-UPDRS Part III up to 12 h post dose at 9 mg single dose. MDS-UPDRS Part III changes in the open-label multiple dose study on day 22 also demonstrated sustained pharmacodynamic activity.ConclusionsPF-06649751 represents a novel therapeutic candidate for Parkinson's disease with an initial safety, tolerability, and pharmacokinetic profile and potential for efficacy that merits further study in larger clinical trials.Trial registrationThese studies are registered at www.clinicaltrials.gov as NCT02373072, NCT02224664.FundingPfizer.

Dataset Information

Oral intake of mesoporous silica is safe and well tolerated in male humans.

Background

Objective

Design

Results

Conclusion

Publications

Oral intake of mesoporous silica is safe and well tolerated in male humans.

Similar Datasets

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