This is a randomized, open label, cross-over study in healthy adult subjects to investigate cotadutide exposure after subcutaneous injection at 3 different anatomical sites. The study will be conducted at a single US center. Each subject will be randomized to receive a single SC dose of 100 μg cotadutide via a pen device according to 6 sequences of dosing. Each SC injection will be administered by a health care provider at a different injection site (arm, thigh, or abdomen) in each period. SC injection in the abdomen will be used as the reference treatment to determine the relative PK of cotadutide 100 μg SC injections in the arm and thigh. Each SC injection of cotadutide will be separated by 7 days washout. Blood samples for PK analyses of cotadutide will be taken pre dose and at 11 time points up to 48 hours after dosing (Days 3, 10, and 17).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
36
SC injection in the upper arm
SC injection in the lower abdomen
SC injection in the thigh
Research Site
Daytona Beach, Florida, United States
Area under the plasma concentration time curve
To evaluate exposure following a single subcutaneous dose of cotadutide at each of 3 different sites of injection.
Time frame: 48 hours
Maximum observed plasma drug concentration
To evaluate exposure following a single subcutaneous dose of cotadutide at each of 3 different sites of injection.
Time frame: 48 hours
Area under the plasma concentration time curve from zero to infinity
To evaluate exposure following a single subcutaneous dose of cotadutide at each of 3 different sites of injection
Time frame: 48 hours
Time to maximum observed plasma drug concentration
To evaluate exposure following a single subcutaneous dose of cotadutide at each of 3 different sites of injection
Time frame: 48 hours
Terminal phase elimination half life
To evaluate exposure following a single subcutaneous dose of cotadutide at each of 3 different sites of injection
Time frame: 48 hours
Apparent clearance
To evaluate exposure following a single subcutaneous dose of cotadutide at each of 3 different sites of injection.
Time frame: 48 hours
Anti drug antibody incidence and titer
To evaluate the immunogenicity of a single subcutaneous dose of cotadutide at each of 3 different sites of injection
Time frame: 43 Days
Incidence of treatment-emergent adverse events, including those related to changes in vital signs (including body temperature, heart rate, blood pressure) and safety laboratory evaluations (including hematology, chemistry, plasma glucose, urinalysis).
To evaluate the safety and tolerability of a single subcutaneous dose of cotadutide at each of 3 different sites of injection.
Time frame: 43 Days
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