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 |
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).
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.
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
We found this trial at
10
sites
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