NCT04091373

A Study Investigating the Pharmacokinetics of a Single Dose Administration of Cotadutide

A Phase 1, Randomized, Open-label, Single Center, Three Period Cross-over Study to Evaluate the Pharmacokinetics of Single Dose Administration of Cotadutide in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
COMBINATION_PRODUCT	cotadutide multidose pen injection	SC injection in the upper arm
COMBINATION_PRODUCT	cotadutide multidose pen injection	SC injection in the lower abdomen
COMBINATION_PRODUCT	cotadutide multidose pen injection	SC injection in the thigh

Timeline

• Start date: 2019-09-27
• Primary completion: 2020-03-06
• Completion: 2020-03-06
• First posted: 2019-09-16
• Last updated: 2020-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study