A Pilot Study Investigating Bioequivalence Between a Single Dose of Formulation 2 and Formulation 3 of MEDI0382

February 13, 2018 updated by: MedImmune LLC

A Phase 1, Randomized, Cross-over, Two-period Pilot Study Investigating Bioequivalence Between a Single Dose of Formulation 2 and Formulation 3 of MEDI0382 in Healthy Adult Subjects

This is a randomized, open label, cross-over, two-period, pilot study in healthy adult subjects to evaluate the bioequivalence between formulation 2 and formulation 3 of MEDI0382 after a single subcutaneous (SC) dose. The study will be conducted at a single US center. Each subject will be randomized to receive a single 100 μg (or equimolar equivalent) SC dose of both formulation 2 and 3 of MEDI0382 on two different in-house periods separated by a washout period of 7 days. Formulation 3 of MEDI0382 has not been administered to humans previously. Blood samples for PK analyses of MEDI0382 concentrations will be taken predose and at 11 time points up to 48 hours after dosing (Days 3 and 12). Bedside plasma glucose levels will be monitored before meals and at bedtime during Days 1 and 10 and will be measured prior to breakfast on Days 2 and 11.

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 is a randomized, open label, cross-over, two-period, pilot study in healthy adult subjects to evaluate the bioequivalence between formulation 2 and formulation 3 of MEDI0382 after a single subcutaneous (SC) dose. The study will be conducted at a single US center. Each subject will be randomized to receive a single 100 μg (or equimolar equivalent) SC dose of both formulation 2 and 3 of MEDI0382 on two different in-house periods separated by a washout period of 7 days. Formulation 3 of MEDI0382 has not been administered to humans previously.

Subjects will receive the same absolute amount of MEDI0382, when dosed with either formulation 2 or formulation 3. Formulations of MEDI0382 will be administered via SC injection in the abdomen of subjects. Subjects will be in the study for a maximum of 59 days, which includes a screening period of up to 21 days. On Day 1, subjects will admitted to the clinic and will be randomized to receive formulation 2 and formulation 3 in one of two sequences; subjects randomized to sequence 1 will receive formulation 2 on Day 1 and formulation 3 on Day 10 and subjects randomized to sequence 2 will receive formulation 3 on Day 1 and formulation 2 on Day 10.

On Day 3, subjects will be discharged from the clinic and a 7-day washout period will follow. Subjects will return to the clinic on Day 10 to receive the second dose of investigational product and will remain in-house for 3 days. After discharge on Day 12, subjects will return on Day 38 for the end of study visit. Blood samples for PK analyses of MEDI0382 concentrations will be taken predose and at 11 time points up to 48 hours after dosing (Days 3 and 12). Bedside plasma glucose levels will be monitored before meals and at bedtime during Days 1 and 10 and will be measured prior to breakfast on Days 2 and 11.

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.
24

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
    • Texas
      • Dallas, Texas, United States, 75247
        • 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 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy subjects age 18 through 45 years at the time of screening.
  2. Provision of signed and dated written informed consent prior to study-specific procedures.
  3. Body mass index between 19 and 30 kg/m2 (inclusive) at screening
  4. Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG, vital signs, and blood and urinary laboratory assessments.
  5. Female subjects of childbearing potential must have a negative pregnancy test at screening and randomization and must not be lactating.
  6. Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception (see Section 10.2 for definition of females of childbearing potential and for a description of highly effective methods of contraception) from screening and must agree to continue using such precautions through to the end of the study. It is strongly recommended for the male partner of a female subject to also use a male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.

Exclusion Criteria:

  1. History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, put the subject at risk, influence the subject's ability to participate, or affect the interpretation of the results of the study
  2. Impaired renal function, defined as s-creatinine ≥ 130 µmol/L
  3. Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2
  4. Blood pressure and heart rate in supine position outside the ranges of 90-140 mmHg systolic, 50-90 mmHg diastolic and heart rate 40-100 beats/min following a 10-minute rest period.
  5. Any clinically significant abnormal ECG, as judged by the investigator
  6. Active hepatitis B, measured by positive tests of surface antigen HBsAg and/or active hepatitis C, measured by positive hepatitis C virus antibody tests
  7. Positive human immunodeficiency virus antibodies
  8. Known or suspected allergy to MEDI0382, any component of the formulation, or related products
  9. Use of any prescription or nonprescription medication, except for paracetamol, hormonal contraceptives, and vitamins within the last 72 hours prior to check-in
  10. History of alcoholism or drug abuse during the last 12 months
  11. Smoking of cigarettes or other tobacco products
  12. Habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the investigator
  13. Blood donation within the last 3 months
  14. Participation in any other trial investigating other products or involving blood sampling within the past 30 days
  15. Potentially noncompliant or uncooperative, as judged by the investigator
  16. Substance dependence likely to impact subject safety or compliance with study procedures
  17. Psychiatric illness such that subjects have been committed to an institution by way of official or judicial order
  18. Involvement of any AstraZeneca, MedImmune, the contract research organization, or the study site employee or their close relatives

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

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.
Experimental: Sequence 1
formulation 2 on Day 1 and formulation 3 on Day 10
Drug: MEDI0382 Formulation 2
Sequence 1 Period 1 and Sequence 2 Period 2.
Drug: MEDI0382 Formulation 3
Sequence 1 Period 2 and Sequence 2 Period 1
Experimental: Sequence 2
formulation 3 on Day 1 and formulation 2 on Day 10
Drug: MEDI0382 Formulation 2
Sequence 1 Period 1 and Sequence 2 Period 2.
Drug: MEDI0382 Formulation 3
Sequence 1 Period 2 and Sequence 2 Period 1

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
Area under the drug concentration curve
Time Frame: 48 hours
To evaluate bioequivalence between formulation 2 and formulation 3 of MEDI0382
48 hours
Maximum observed plasma concentration of MEDI0382
Time Frame: 48 hours
To evaluate bioequivalence between formulation 2 and formulation 3 of MEDI0382.
48 hours

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
Area under the plasma drug concentration versus time curve from zero to infinity and to last observation
Time Frame: 48 hours
To compare the pharmacokinetic (PK) profiles of MEDI0382 formulation 2 versus formulation 3.
48 hours
Time to maximum observed plasma drug concentration
Time Frame: 48 hours
To compare the pharmacokinetic (PK) profiles of MEDI0382 formulation 2 versus formulation 3.
48 hours
Terminal phase elimination half-life
Time Frame: 48 hours
To compare the pharmacokinetic (PK) profiles of MEDI0382 formulation 2 versus formulation 3.
48 hours
Apparent clearance
Time Frame: 48 hours
To compare the pharmacokinetic (PK) profiles of MEDI0382 formulation 2 versus formulation 3.
48 hours
Adverse Events
Time Frame: 38 days
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3.
38 days
12 lead electrocardiogram including RR, PR, QRS, QT, and QTc intervals
Time Frame: 38 days
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3.
38 days
Anti-drug antibody titer
Time Frame: 38 days
To evaluate the immunogenicity of a single dose of MEDI0382 in formulation 2 and 3.
38 days
Vital signs (temperature)
Time Frame: 38 days
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3
38 days
Anti-drug antibody incidence
Time Frame: 38 days
To evaluate the immunogenicity of a single dose of MEDI0382 in formulation 2 and 3.
38 days
Clinical laboratory assessments (hematology)
Time Frame: 38 days
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3
38 days
Vital signs (systolic and diastolic blood pressure)
Time Frame: 38 days
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3.
38 days
Vital signs (pulse rate and respiratory rate)
Time Frame: 38 days
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3
38 days
Clinical laboratory assessments (serum chemistry)
Time Frame: 38 days
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3
38 days
Clinical laboratory assessments (urinalysis)
Time Frame: 38 days
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3
38 days

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

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.
November 30, 2017

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.
January 29, 2018

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.
January 29, 2018

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).
October 11, 2017

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.
November 8, 2017

First Posted (Actual)

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.
November 14, 2017

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.
February 14, 2018

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.
February 13, 2018

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.
February 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.
  • D5670C00003

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.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on MEDI0382 Formulation 2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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