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

Sponsor
MedImmune LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT02524782
Collaborator
(none)
103
Enrollment
11
Locations
2
Arms
18.2
Actual Duration (Months)
9.4
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Biological: MEDI-4166
  • Biological: Placebo
 Phase 1

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
103 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Oct 7, 2015
Actual Primary Completion Date :
Apr 14, 2017
Actual Study Completion Date :
Apr 14, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: MEDI-4166

MEDI-4166 administered subcutaneously

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

Placebo administered subcutaneously

Biological: Placebo
Placebo administered subcutaneously

Outcome Measures

Primary Outcome Measures

  1. Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 [43 days post dosing]

    Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)

  2. Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 [43 days post dosing]

    12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals

  3. Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 [43 days post dosing]

    Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rate)

  4. Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 [43 days post dosing]

    Clinical laboratory assessments (serum chemistry, hematology, urinalysis)

  5. Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 [43 days post dosing]

    Physical examination

  6. 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]

    Part B: Change in glucose AUC measured up to 240 minutes after mixed meal tolerance test (MMTT) from baseline to Day 36

  7. Part B: Change in LDL-C from baseline to Day 36 [36 days post dosing]

    Part B: Change in LDL-C from baseline to Day 36

Secondary Outcome Measures

  1. Part A: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax) [43 days post dosing]

    Part A: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)

  2. Part A: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC) [43 days post dosing]

    Part A: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)

  3. Part A: Change from baseline in LDL-C [43 days post dosing]

    Part A: Change from baseline in LDL-C

  4. Part A: Proportion of subjects with Anti-drug Antibodies (ADA) to MEDI4166 [43 days post dosing]

    Part A: Proportion of subjects with ADA to MEDI4166

  5. Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 [71 days post dosing]

    Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)

  6. Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 [71 days post dosing]

    12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals

  7. Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 [71 days post dosing]

    Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rate)

  8. Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 [71 days post dosing]

    Clinical laboratory assessments (serum chemistry, hematology, urinalysis)

  9. Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 [71 days post dosing]

    Physical examination

  10. Part B: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax) [71 days post dosing]

    Part B: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)

  11. Part B: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC) [71 days post dosing]

    Part B: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)

  12. Part B: Change from baseline in fructosamine levels [36 days post dosing]

    Part B: Change from baseline in fructosamine levels

  13. Part B: Proportion of subjects with ADA to MEDI4166 [71 days post dosing]

    Part B: Proportion of subjects with ADA to MEDI4166

  14. Part A: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax) [43 days post dosing]

    Part A: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)

  15. Part A: Change from baseline in glucose AUC up to 240 minutes [43 days post dosing]

    Part A: Change from baseline in glucose AUC up to 240 minutes

  16. Part B: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax) [71 days post dosing]

    Part B: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site Anniston Alabama United States 36207
2 Research Site Chula Vista California United States 91911
3 Research Site Jacksonville Florida United States 32216
4 Research Site Miami Florida United States 33014
5 Research Site South Miami Florida United States 33143
6 Research Site Durham North Carolina United States 27710
7 Research Site Raleigh North Carolina United States 27612
8 Research Site Cincinnati Ohio United States 45227
9 Research Site Knoxville Tennessee United States 37920
10 Research Site San Antonio Texas United States 78209
11 Research Site San Antonio Texas United States 78229

Sponsors and Collaborators

  • MedImmune LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT02524782
Other Study ID Numbers:
  • D6240C00001
First Posted:
Aug 17, 2015
Last Update Posted:
Mar 13, 2019
Last Verified:
Mar 1, 2018
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by MedImmune LLC
MEDI-4166, diabetes
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Mar 13, 2019