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

NCT04091373 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-04-07

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-27
Primary Completion
2020-03-06
Completion
2020-03-06
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04091373 on ClinicalTrials.gov