A Pilot Study Investigating Bioequivalence Between a Single Dose of Formulation 2 and Formulation 3 of MEDI0382
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): MEDI0382 Formulation 2; MEDI0382 Formulation 3
Intervention type(s): Drug; Drug
Intervention description(s): Sequence 1 Period 1 and Sequence 2 Period 2.; Sequence 1 Period 2 and Sequence 2 Period 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Type 2 Diabetes Mellitus; GLP-1 receptor agonists