40
Participants
Start Date
September 1, 2025
Primary Completion Date
September 1, 2028
Study Completion Date
September 1, 2030
Metformin (open-label)
Enteric metformin 5mg/kg/day in two divided doses will be given for three days to two subjects
Metformin (open-label)
Enteric metformin 10mg/kg/day in two divided doses will be given for three days to two subjects.
Metformin (open-label)
Enteric metformin 20mg/kg/day in two divided doses will be given for seven days to three subjects.
Metformin (open-label)
Enteric metformin 25mg/kg/day in two divided doses will be given for 14 days to three subjects.
Metformin (open-label)
Enteric metformin 15mg/kg/day in a single daily dose will be given for three days to 3-6 subjects. Depending on tolerance, the next Cohort will increase to 25mg/kg/day (Cohort 2) or decrease to 10mg/kg/day (Cohort 3)
Metformin (open-label)
Enteric metformin 25mg/kg/day in a single daily dose will be given for three days to 3-6 subjects. Depending on tolerance, either 25mg/kg/day or 15mg/kg/day will be dose selected for the next Cohort (Cohort 4)
Metformin (open-label)
Enteric metformin 10mg/kg/day in a single daily dose will be given for three days to 3-6 subjects. Depending on tolerance, either 10mg/kg/day dose selected for the next Cohort (Cohort 4) or the study will be stopped due to excessive toxicity.
Metformin (open-label)
The dose for this cohort will be selected from either Cohort 2 or 3 based on tolerance. Enteric metformin 10-25mg/kg/day in a single daily dose will be given for seven days to 6 subjects.
Metformin (open-label)
The dose for this cohort will be the same as Cohort 4. Enteric metformin 10-25mg/kg/day in a single daily dose will be given for 14 days to 6 subjects.
Children's Wisconsin, Milwaukee
Medical College of Wisconsin
OTHER