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

Type 2 Diabetes Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02524782
• Other study ID #: D6240C00001
• Status: Completed
• Phase: Phase 1
• Start date: October 7, 2015
• Est. completion date: April 14, 2017

Study information

• Verified date: March 2018
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: April 14, 2017
• Est. primary completion date: April 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Biological:
• MEDI-4166
MEDI-4166 administered subcutaneously
• Placebo
Placebo administered subcutaneously

Locations

Country	Name	City	State
United States	Research Site	Anniston	Alabama
United States	Research Site	Chula Vista	California
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Durham	North Carolina
United States	Research Site	Jacksonville	Florida
United States	Research Site	Knoxville	Tennessee
United States	Research Site	Miami	Florida
United States	Research Site	Raleigh	North Carolina
United States	Research Site	San Antonio	Texas
United States	Research Site	San Antonio	Texas
United States	Research Site	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166	Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)	43 days post dosing
Primary	Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166	12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals	43 days post dosing
Primary	Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166	Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rate)	43 days post dosing
Primary	Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166	Clinical laboratory assessments (serum chemistry, hematology, urinalysis)	43 days post dosing
Primary	Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166	Physical examination	43 days post dosing
Primary	Part B: Change in glucose AUC measured up to 240 minutes after mixed meal tolerance test (MMTT) from baseline to Day 36	Part B: Change in glucose AUC measured up to 240 minutes after mixed meal tolerance test (MMTT) from baseline to Day 36	36 days post dosing
Primary	Part B: Change in LDL-C from baseline to Day 36	Part B: Change in LDL-C from baseline to Day 36	36 days post dosing
Secondary	Part A: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)	Part A: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)	43 days post dosing
Secondary	Part A: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)	Part A: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)	43 days post dosing
Secondary	Part A: Change from baseline in LDL-C	Part A: Change from baseline in LDL-C	43 days post dosing
Secondary	Part A: Proportion of subjects with Anti-drug Antibodies (ADA) to MEDI4166	Part A: Proportion of subjects with ADA to MEDI4166	43 days post dosing
Secondary	Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166	Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)	71 days post dosing
Secondary	Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166	12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals	71 days post dosing
Secondary	Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166	Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rate)	71 days post dosing
Secondary	Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166	Clinical laboratory assessments (serum chemistry, hematology, urinalysis)	71 days post dosing
Secondary	Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166	Physical examination	71 days post dosing
Secondary	Part B: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)	Part B: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)	71 days post dosing
Secondary	Part B: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)	Part B: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)	71 days post dosing
Secondary	Part B: Change from baseline in fructosamine levels	Part B: Change from baseline in fructosamine levels	36 days post dosing
Secondary	Part B: Proportion of subjects with ADA to MEDI4166	Part B: Proportion of subjects with ADA to MEDI4166	71 days post dosing
Secondary	Part A: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)	Part A: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)	43 days post dosing
Secondary	Part A: Change from baseline in glucose AUC up to 240 minutes	Part A: Change from baseline in glucose AUC up to 240 minutes	43 days post dosing
Secondary	Part B: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)	Part B: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)	71 days post dosing