Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Phase 1, Randomized, Cross-over, Two-period Pilot Study Investigating Bioequivalence Between a Single Dose of Formulation 2 and Formulation 3 of MEDI0382 in Healthy Adult Subjects
This is a randomized, open label, cross-over, two-period, pilot study in healthy adult subjects to evaluate the bioequivalence between formulation 2 and formulation 3 of MEDI0382 after a single subcutaneous (SC) dose. The study will be conducted at a single US center. Each subject will be randomized to receive a single 100 μg (or equimolar equivalent) SC dose of both formulation 2 and 3 of MEDI0382 on two different in-house periods separated by a washout period of 7 days. Formulation 3 of MEDI0382 has not been administered to humans previously. Blood samples for PK analyses of MEDI0382 concentrations will be taken predose and at 11 time points up to 48 hours after dosing (Days 3 and 12). Bedside plasma glucose levels will be monitored before meals and at bedtime during Days 1 and 10 and will be measured prior to breakfast on Days 2 and 11.
This is a randomized, open label, cross-over, two-period, pilot study in healthy adult
subjects to evaluate the bioequivalence between formulation 2 and formulation 3 of MEDI0382
after a single subcutaneous (SC) dose. The study will be conducted at a single US center.
Each subject will be randomized to receive a single 100 μg (or equimolar equivalent) SC dose
of both formulation 2 and 3 of MEDI0382 on two different in-house periods separated by a
washout period of 7 days. Formulation 3 of MEDI0382 has not been administered to humans
previously.
Subjects will receive the same absolute amount of MEDI0382, when dosed with either
formulation 2 or formulation 3. Formulations of MEDI0382 will be administered via SC
injection in the abdomen of subjects. Subjects will be in the study for a maximum of 59 days,
which includes a screening period of up to 21 days. On Day 1, subjects will admitted to the
clinic and will be randomized to receive formulation 2 and formulation 3 in one of two
sequences; subjects randomized to sequence 1 will receive formulation 2 on Day 1 and
formulation 3 on Day 10 and subjects randomized to sequence 2 will receive formulation 3 on
Day 1 and formulation 2 on Day 10.
On Day 3, subjects will be discharged from the clinic and a 7-day washout period will follow.
Subjects will return to the clinic on Day 10 to receive the second dose of investigational
product and will remain in-house for 3 days. After discharge on Day 12, subjects will return
on Day 38 for the end of study visit. Blood samples for PK analyses of MEDI0382
concentrations will be taken predose and at 11 time points up to 48 hours after dosing (Days
3 and 12). Bedside plasma glucose levels will be monitored before meals and at bedtime during
Days 1 and 10 and will be measured prior to breakfast on Days 2 and 11.
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