A Phase 1, Single- and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MEDI4166 in Subjects With Type 2 Diabetes

Completed · Phase 1 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

A Phase 1, combined Single Ascending Dose (SAD) and Multiple-ascending Dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MEDI4166 in Subjects with Type 2 Diabetes Mellitus (T2D).

Key facts

Study ID

NCT02524782

Run by

MedImmune LLC

People needed

103

Starts

2015-10-07

Expected to finish

2017-04-14

Last updated by the study team

2019-03-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 2 Diabetes, ages 18-65
• Must provide written informed consent
• BMI>=25 and =<42
• 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

You may not qualify if…

• 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 basal cell carcinoma or carcinoma of the cervix
• 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
• 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 weight loss is prohibited.
• Positive drug screen
• Type 1 diabetes

Where it is running

• Research Site — Anniston, Alabama, United States
• Research Site — Chula Vista, California, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — South Miami, Florida, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Raleigh, North Carolina, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Knoxville, Tennessee, United States
• Research Site — San Antonio, Texas, United States
• Research Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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