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Clinical Trial Details

Trial ID: L5935
Source ID: NCT03341013
Associated Drug: Medi0382 Formulation 2
Title: A Pilot Study Investigating Bioequivalence Between a Single Dose of Formulation 2 and Formulation 3 of MEDI0382
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: MEDI0382 Formulation 2|DRUG: MEDI0382 Formulation 3
Outcome Measures: Primary: Area under the drug concentration curve, To evaluate bioequivalence between formulation 2 and formulation 3 of MEDI0382, 48 hours|Maximum observed plasma concentration of MEDI0382, To evaluate bioequivalence between formulation 2 and formulation 3 of MEDI0382., 48 hours | Secondary: Area under the plasma drug concentration versus time curve from zero to infinity and to last observation, To compare the pharmacokinetic (PK) profiles of MEDI0382 formulation 2 versus formulation 3., 48 hours|Time to maximum observed plasma drug concentration, To compare the pharmacokinetic (PK) profiles of MEDI0382 formulation 2 versus formulation 3., 48 hours|Terminal phase elimination half-life, To compare the pharmacokinetic (PK) profiles of MEDI0382 formulation 2 versus formulation 3., 48 hours|Apparent clearance, To compare the pharmacokinetic (PK) profiles of MEDI0382 formulation 2 versus formulation 3., 48 hours|Adverse Events, To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3., 38 days|12 lead electrocardiogram including RR, PR, QRS, QT, and QTc intervals, To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3., 38 days|Anti-drug antibody titer, To evaluate the immunogenicity of a single dose of MEDI0382 in formulation 2 and 3., 38 days|Vital signs (temperature), To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3, 38 days|Anti-drug antibody incidence, To evaluate the immunogenicity of a single dose of MEDI0382 in formulation 2 and 3., 38 days|Clinical laboratory assessments (hematology), To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3, 38 days|Vital signs (systolic and diastolic blood pressure), To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3., 38 days|Vital signs (pulse rate and respiratory rate), To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3, 38 days|Clinical laboratory assessments (serum chemistry), To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3, 38 days|Clinical laboratory assessments (urinalysis), To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3, 38 days
Sponsor/Collaborators: Sponsor: MedImmune LLC
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2017-11-30
Completion Date: 2018-01-29
Results First Posted:
Last Update Posted: 2018-02-14
Locations: Research Site, Dallas, Texas, 75247, United States
URL: https://clinicaltrials.gov/show/NCT03341013