NCT03557138 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Geist BK, Baltzer P, Fueger B, Hamboeck M, Nakuz T, Papp L, Rasul S, Sundar LKS, Hacker M, Staudenherz A
Assessing the kidney function parameters glomerular filtration rate and effective renal plasma flow with dynamic FDG-PET/MRI in healthy subjects. EJNMMI Res. 2018 May 9;8(1):37. doi: 10.1186/s13550-018-0389-1.
Kobayashi M, Shikano N, Nishii R, Kiyono Y, Araki H, Nishi K, Oh M, Okudaira H, Ogura M, Yoshimoto M, Okazawa H, Fujibayashi Y, Kawai K
Comparison of the transcellular transport of FDG and D-glucose by the kidney epithelial cell line, LLC-PK1. Nucl Med Commun. 2010 Feb;31(2):141-6. doi: 10.1097/MNM.0b013e328333bcf5.

Study to Develop a Kinetic Model for FDG and Me4FDG in Kidneys of Type 2 Diabetic Patients With SGLT2 Inhibitor Therapies

Clinical trial NCT03557138 - References