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

March 12, 2019 updated by: MedImmune LLC

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Research Site
    • California
      • Chula Vista, California, United States, 91911
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Research Site
      • Miami, Florida, United States, 33014
        • Research Site
      • South Miami, Florida, United States, 33143
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Research Site
      • Raleigh, North Carolina, United States, 27612
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • Research Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Research Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Research Site
      • San Antonio, Texas, United States, 78209
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo administered subcutaneously
Biological: Placebo
Placebo administered subcutaneously
Experimental: MEDI-4166
MEDI-4166 administered subcutaneously
Biological: MEDI-4166
MEDI-4166 administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166
Time Frame: 43 days post dosing
Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)
43 days post dosing
Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166
Time Frame: 43 days post dosing
12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals
43 days post dosing
Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166
Time Frame: 43 days post dosing
Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rate)
43 days post dosing
Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166
Time Frame: 43 days post dosing
Clinical laboratory assessments (serum chemistry, hematology, urinalysis)
43 days post dosing
Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166
Time Frame: 43 days post dosing
Physical examination
43 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
Time Frame: 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
36 days post dosing
Part B: Change in LDL-C from baseline to Day 36
Time Frame: 36 days post dosing
Part B: Change in LDL-C from baseline to Day 36
36 days post dosing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part A: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)
Time Frame: 43 days post dosing
Part A: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)
43 days post dosing
Part A: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)
Time Frame: 43 days post dosing
Part A: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)
43 days post dosing
Part A: Change from baseline in LDL-C
Time Frame: 43 days post dosing
Part A: Change from baseline in LDL-C
43 days post dosing
Part A: Proportion of subjects with Anti-drug Antibodies (ADA) to MEDI4166
Time Frame: 43 days post dosing
Part A: Proportion of subjects with ADA to MEDI4166
43 days post dosing
Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166
Time Frame: 71 days post dosing
Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)
71 days post dosing
Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166
Time Frame: 71 days post dosing
12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals
71 days post dosing
Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166
Time Frame: 71 days post dosing
Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rate)
71 days post dosing
Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166
Time Frame: 71 days post dosing
Clinical laboratory assessments (serum chemistry, hematology, urinalysis)
71 days post dosing
Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166
Time Frame: 71 days post dosing
Physical examination
71 days post dosing
Part B: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)
Time Frame: 71 days post dosing
Part B: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)
71 days post dosing
Part B: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)
Time Frame: 71 days post dosing
Part B: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)
71 days post dosing
Part B: Change from baseline in fructosamine levels
Time Frame: 36 days post dosing
Part B: Change from baseline in fructosamine levels
36 days post dosing
Part B: Proportion of subjects with ADA to MEDI4166
Time Frame: 71 days post dosing
Part B: Proportion of subjects with ADA to MEDI4166
71 days post dosing
Part A: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)
Time Frame: 43 days post dosing
Part A: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)
43 days post dosing
Part A: Change from baseline in glucose AUC up to 240 minutes
Time Frame: 43 days post dosing
Part A: Change from baseline in glucose AUC up to 240 minutes
43 days post dosing
Part B: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)
Time Frame: 71 days post dosing
Part B: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)
71 days post dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MedImmune LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 14, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 14, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D6240C00001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings