Clinical trials: Polysorbate 80
Drug Related Side Effects and Adverse Reactions, Infusion Reactions
Retrospective Kinetic Safety Evaluation of an Intravenous Micellar Excipient Platform
Protocol PICO-RWE-001: The goal of this observational study is to evaluate the kinetic safety and tolerability of an investigational intravenous micellar delivery platform.
- Trial name
- NCT07609069
- Testing
- PIV-850 (850-picometer Dual-NCE Acidic Matrix), Legacy Heterogeneous Payload (Micellar Vehicle)
- Where
- United States
- Volunteers
- 625 people
- Sponsor
- PICO IV, Inc.
Inclisiran Formulation
Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation
The purpose of this study is to compare safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the currently marketed formulation of inclisiran with a new formulation containing polysorbate 80 (PS80), after a…
- Trial name
- NCT07626281
- Testing
- Inclisiran formulation containing PS80, Currently marketed inclisiran formulation
- Where
- 6 sites in United States
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Bile Salt Export Pump (BSEP) Transporter, Polysorbate 80
Impact of Metformin and Polysorbate 80 on Drug Absorption and Disposition
The study employs two-sub-studies that share a common placebo arm. The objective of one sub-study is to assess the impact of metformin on pravastatin and chenodeoxycholic acid pharmacokinetics.
- Trial name
- NCT04640571
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Vaccines, Pneumococcal
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared to a 13-valent pneumococcal conjugate (13vPnC)…
- Trial name
- NCT00366548
- Testing
- 13 valent pneumococcal conjugate vaccine with Polysorbate 80, 13 valent pneumococcal conjugate vaccine without Polysorbate 80
- Where
- 14 sites in Poland
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Neoplasms
Study Evaluating MST-997 in Advanced Malignant Solid Tumors
MST-997 is a taxane analog with the potential to treat subjects with a variety of tumor types. Preclinical data demonstrated that MST-997 inhibited tumor growth when administered intravenously (IV).
- Trial name
- NCT00277836
- Testing
- MST-997
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer