Type 2 Diabetes MellitusPhase 1NCT03341013
A Pilot Study Investigating Bioequivalence Between a Single Dose of Formulation 2 and Formulation 3 of MEDI0382
A Phase 1 study testing MEDI0382 Formulation 2 and MEDI0382 Formulation 3 in people with Type 2 Diabetes Mellitus, run by MedImmune LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- MEDI0382 Formulation 2 and MEDI0382 Formulation 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2017to 29 Jan 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects age 18 through 45 years at the time of screening.
- Provision of signed and dated written informed consent prior to study-specific procedures.
- Body mass index between 19 and 30 kg/m2 (inclusive) at screening
- 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.
- Female subjects of childbearing potential must have a negative pregnancy test at screening and randomization and must not be lactating.
- 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.
Who cannot join
- 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
- Impaired renal function, defined as s-creatinine ≥ 130 µmol/L
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2
- 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.
- Any clinically significant abnormal ECG, as judged by the investigator
- Active hepatitis B, measured by positive tests of surface antigen HBsAg and/or active hepatitis C, measured by positive hepatitis C virus antibody tests
Show all 18Show fewer
- Positive human immunodeficiency virus antibodies
- Known or suspected allergy to MEDI0382, any component of the formulation, or related products
- Use of any prescription or nonprescription medication, except for paracetamol, hormonal contraceptives, and vitamins within the last 72 hours prior to check-in
- History of alcoholism or drug abuse during the last 12 months
- Smoking of cigarettes or other tobacco products
- 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
- Blood donation within the last 3 months
- Participation in any other trial investigating other products or involving blood sampling within the past 30 days
- Potentially noncompliant or uncooperative, as judged by the investigator
- Substance dependence likely to impact subject safety or compliance with study procedures
- Psychiatric illness such that subjects have been committed to an institution by way of official or judicial order
- Involvement of any AstraZeneca, MedImmune, the contract research organization, or the study site employee or their close relatives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- MEDI0382 Formulation 2, MEDI0382 Formulation 3
- Keywords
- Type 2 Diabetes Mellitus, GLP-1 receptor agonists
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI0382 Formulation 2Drug
Sequence 1 Period 1 and Sequence 2 Period 2.
MEDI0382 Formulation 3Drug
Sequence 1 Period 2 and Sequence 2 Period 1
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | formulation 2 on Day 1 and formulation 3 on Day 10 Receives: Drug: MEDI0382 Formulation 2; Drug: MEDI0382 Formulation 3 |
| Sequence 2 | Experimental | formulation 3 on Day 1 and formulation 2 on Day 10 Receives: Drug: MEDI0382 Formulation 2; Drug: MEDI0382 Formulation 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the drug concentration curve
To evaluate bioequivalence between formulation 2 and formulation 3 of MEDI0382
Measured: 48 hours
Maximum observed plasma concentration of MEDI0382
To evaluate bioequivalence between formulation 2 and formulation 3 of MEDI0382.
Measured: 48 hours
Secondary outcomes (14)
Area under the plasma drug concentration versus time curve from zero to infinity and to last observation
To compare the pharmacokinetic (PK) profiles of MEDI0382 formulation 2 versus formulation 3.
Measured: 48 hours
Time to maximum observed plasma drug concentration
To compare the pharmacokinetic (PK) profiles of MEDI0382 formulation 2 versus formulation 3.
Measured: 48 hours
Terminal phase elimination half-life
To compare the pharmacokinetic (PK) profiles of MEDI0382 formulation 2 versus formulation 3.
Measured: 48 hours
Apparent clearance
To compare the pharmacokinetic (PK) profiles of MEDI0382 formulation 2 versus formulation 3.
Measured: 48 hours
Adverse Events
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3.
Measured: 38 days
12 lead electrocardiogram including RR, PR, QRS, QT, and QTc intervals
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3.
Measured: 38 days
Anti-drug antibody titer
To evaluate the immunogenicity of a single dose of MEDI0382 in formulation 2 and 3.
Measured: 38 days
Vital signs (temperature)
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3
Measured: 38 days
Anti-drug antibody incidence
To evaluate the immunogenicity of a single dose of MEDI0382 in formulation 2 and 3.
Measured: 38 days
Clinical laboratory assessments (hematology)
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3
Measured: 38 days
Vital signs (systolic and diastolic blood pressure)
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3.
Measured: 38 days
Vital signs (pulse rate and respiratory rate)
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3
Measured: 38 days
Clinical laboratory assessments (serum chemistry)
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3
Measured: 38 days
Clinical laboratory assessments (urinalysis)
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3
Measured: 38 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start30 Nov 2017
- Primary completion29 Jan 2018
- Study completion29 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341013
- Sponsor's protocol ID
- D5670C00003
- Status last verified
- Feb 2018
- First submitted
- 11 Oct 2017
- Last updated
- 14 Feb 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03341013
- Acronym / sponsor ID
- D5670C00003
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, GLP-1 receptor agonists
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 29 Jan 2018 (actual)
- Study completion
- 29 Jan 2018 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: MEDI0382 Formulation 2, Drug: MEDI0382 Formulation 3formulation 2 on Day 1 and formulation 3 on Day 10 |
| Sequence 2 | Experimental | Drug: MEDI0382 Formulation 2, Drug: MEDI0382 Formulation 3formulation 3 on Day 1 and formulation 2 on Day 10 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy subjects age 18 through 45 years at the time of screening.
- Provision of signed and dated written informed consent prior to study-specific procedures.
- Body mass index between 19 and 30 kg/m2 (inclusive) at screening
- 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.
- Female subjects of childbearing potential must have a negative pregnancy test at screening and randomization and must not be lactating.
Key exclusion criteria (18 listed)
- 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
- Impaired renal function, defined as s-creatinine ≥ 130 µmol/L
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2
- 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.
- Any clinically significant abnormal ECG, as judged by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDI0382 Formulation 2Sequence 1 Period 1 and Sequence 2 Period 2. | Drug | Sequence 1, Sequence 2 |
| MEDI0382 Formulation 3Sequence 1 Period 2 and Sequence 2 Period 1 | Drug | Sequence 1, Sequence 2 |
Primary outcome
Area under the drug concentration curve
Time frame: 48 hours
To evaluate bioequivalence between formulation 2 and formulation 3 of MEDI0382
Maximum observed plasma concentration of MEDI0382
Time frame: 48 hours
To evaluate bioequivalence between formulation 2 and formulation 3 of MEDI0382.
14 secondary outcomes
Area under the plasma drug concentration versus time curve from zero to infinity and to last observation
Time frame: 48 hours
Time to maximum observed plasma drug concentration
Time frame: 48 hours
Terminal phase elimination half-life
Time frame: 48 hours
Apparent clearance
Time frame: 48 hours
Adverse Events
Time frame: 38 days
12 lead electrocardiogram including RR, PR, QRS, QT, and QTc intervals
Time frame: 38 days
Anti-drug antibody titer
Time frame: 38 days
Vital signs (temperature)
Time frame: 38 days
Anti-drug antibody incidence
Time frame: 38 days
Clinical laboratory assessments (hematology)
Time frame: 38 days
Vital signs (systolic and diastolic blood pressure)
Time frame: 38 days
Vital signs (pulse rate and respiratory rate)
Time frame: 38 days
Clinical laboratory assessments (serum chemistry)
Time frame: 38 days
Clinical laboratory assessments (urinalysis)
Time frame: 38 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI0382 Formulation 2 and MEDI0382 Formulation 3 in people with Type 2 Diabetes Mellitus, run by MedImmune LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the drug concentration curve (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.