GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT02394314

CompletedPhase 1

A Phase 1, Single Dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Healthy Volunteers

A Phase 1, Single-ascending-dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Healthy Volunteers

Lead sponsor

MedImmune LLC

Asset

Cotadutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

—

Enrollment

362

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 22-30•Healthy volunteers

Primary endpoints

•Treatment-emergent AEs (any)•Nausea (Nausea, Vomiting)•Adverse events as a measure of safety and tolerability of MEDI0382

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02394314

Org study IDD5670C00001

Timeline

Milestones

Study first posted2015-03-20estimated

Last update posted2015-09-09estimated

Study start2015-02 (month precision)

Primary completion2015-08actual (month precision)

Study completion2015-08actual (month precision)

Assets

Investigational agents

Cotadutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Healthy Volunteers, ages 18-45

•Must provide written informed consent

•BMI >22 and <30 kg/m2 and body weight >70kg

•Venous access suitable for multiple cannulations

•Vital signs within normal specified ranges

•Females must be non-lactating and non-childbearing potential

•Males must practice 2 effective contraceptive measures if sexually active

Exclusion criteria

•Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product

•History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs

•History of cancer, with the exception of non-melanoma skin cancer

•Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing

•Positive Hepatitis B, Hepatitis C or HIV test or use of antiretroviral medications at screening.

•Concurrent or previous use of a GLP-1 receptor agonist

•Current or previous use of systemic corticosteroids within the past 28 days prior to screening

•Use of any medicinal products or herbal preparations licensed for control of body weight or appetite is prohibited.

•Known or suspected history of alcohol or drug abuse within the past 3 years.

•Positive drug screen

•Current smoker

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.