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



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:3/15/2019
Start Date:October 7, 2015
End Date:April 14, 2017

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A Phase 1, Combined Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of MEDI4166 in Subjects With Type 2 Diabetes Mellitus (T2D)

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).

This study is a first time in human (FTIH), Phase 1, randomized, double-blind study to
evaluate the safety, tolerability, PK, and PD of MEDI4166 administered as both single and
multiple ascending doses to subjects with T2D.

Inclusion Criteria:

- 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

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 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
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10
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283
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Knoxville, TN
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Anniston, AL
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Chula Vista, CA
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Cincinnati, OH
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354
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Durham, NC
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Jacksonville, FL
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Miami, FL
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371
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Raleigh, NC
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1144
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San Antonio, TX
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997
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South Miami, FL
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