Type 2 Diabetes MellitusPhase 1NCT04091373
A Study Investigating the Pharmacokinetics of a Single Dose Administration of Cotadutide
A Phase 1 study testing cotadutide multidose pen injection 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 study in healthy adult subjects to investigate cotadutide exposure after subcutaneous injection at 3 different anatomical sites. The study will be conducted at a single US center. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- cotadutide multidose pen injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2019to 6 Mar 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects aged 18 through 60 years (inclusive) at the time of screening.
- Electronic and/or written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- BMI 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 electrocardiogram (ECG), vital signs, and blood and urinary laboratory assessments.
- Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of investigational product, and must not be breastfeeding.
- Female subjects of childbearing potential who are sexually active with a male partner must be using at least one highly effective method of contraception from screening and up to 4 weeks after the last dose of investigational product. As applicable, at least one method must be in effect prior to receiving the first dose of investigational product.
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 interpretation of subject safety or study results.
- Inflammatory bowel disease, gastroparesis or other severe disease or surgery affecting the upper GI tract, which may affect gastric emptying or could affect the interpretation of safety and tolerability data.
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2; eGFR will be determined by the chronic kidney disease - epidemiology collaboration (CKD-EPI) equation.
- BP 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.
- Active hepatitis B, measured by positive tests of surface antigen HBsAg and/or active hepatitis C, measured by positive hepatitis C virus antibody tests.
- Positive human immunodeficiency virus (HIV) antibodies.
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- Subjects with a history of acute or chronic pancreatitis.
- Subjects with a history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, and subjects with a screening/baseline serum calcitonin ≥ 50 ng/L.
- Signs or symptoms of severe hepatic impairment AND any of the following laboratory values at screening: Aspartate transaminase (AST) ≥ 3 × upper limit of normal (ULN), alanine transaminase (ALT) ≥ 3 × ULN, or total bilirubin (TBL) ≥ 2 × ULN. Alternatively, AST ≥ 5 × ULN, ALT ≥ 5 × ULN, or TBL ≥ 2 × ULN regardless of signs and symptoms. An isolated increase in TBL in subjects with known Gilbert's syndrome is not a reason for exclusion.
- Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight loss), a history of type 1 diabetes mellitus or diabetic ketoacidosis.
- History of neoplastic disease within 5 years prior to screening except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
- Known or suspected allergy to cotadutide, any component of the formulation, or related products.
- Use of any prescription or nonprescription medication, with the exception of permitted concomitant medications, within the last 72 hours prior to Day 1.
- History of alcoholism or drug abuse during the last 12 months.
- Current smoker of cigarettes or other tobacco products.
- Habitual excessive consumption of methylxanthine containing (theophylline, caffeine, or theobromine) beverages and foods (eg, coffee, tea, red bull, cola, chocolate) as judged by the investigator.
- Blood donation within the last 3 months.
- Participation in any other study 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, to include a positive test result for drugs of abuse and/or alcohol at screening or prior to administration of investigational product on Day 1.
- 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 center employee or their close relatives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Open-label, Single Center, Three Period Cross-over Study to Evaluate the Pharmacokinetics of Single Dose Administration of Cotadutide in Healthy Subjects
This is a randomized, open label, cross-over study in healthy adult subjects to investigate cotadutide exposure after subcutaneous injection at 3 different anatomical sites. The study will be conducted at a single US center. Each subject will be randomized to receive a single SC dose of 100 μg cotadutide via a pen device according to 6 sequences of dosing. Each SC injection will be administered by a health care provider at a different injection site (arm, thigh, or abdomen) in each period. SC injection in the abdomen will be used as the reference treatment to determine the relative PK of cotadutide 100 μg SC injections in the arm and thigh. Each SC injection of cotadutide will be separated by 7 days washout. Blood samples for PK analyses of cotadutide will be taken pre dose and at 11 time points up to 48 hours after dosing (Days 3, 10, and 17).
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- cotadutide multidose pen injection
- 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.
cotadutide multidose pen injectionCombination product
SC injection in the upper arm
cotadutide multidose pen injectionCombination product
SC injection in the lower abdomen
cotadutide multidose pen injectionCombination product
SC injection in the thigh
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | 100ug SC injection cotadutide in the upper arm on Day 1, in the lower abdomen on Day 8, and in the thigh on Day 15 Receives: Combination Product: cotadutide multidose pen injection |
| Sequence 2 | Experimental | 100ug SC injection cotadutide in the thigh on Day 1, in the upper arm on Day 8, and in the lower abdomen on Day 15 Receives: Combination Product: cotadutide multidose pen injection |
| Sequence 3 | Experimental | 100ug SC injection cotadutide in the lower abdomen on Day 1, in the thigh on Day 8, and in the upper arm on Day 15 Receives: Combination Product: cotadutide multidose pen injection |
| Sequence 4 | Experimental | 100ug SC injection cotadutide in the thigh on Day 1, in the lower abdomen on Day 8, and in the upper arm on Day 15 Receives: Combination Product: cotadutide multidose pen injection |
| Sequence 5 | Experimental | 100ug SC injection cotadutide in the lower abdomen on Day 1, in the upper arm on Day 8, and in the thigh on Day 15 Receives: Combination Product: cotadutide multidose pen injection |
| Sequence 6 | Experimental | 100ug SC injection cotadutide in the upper arm on Day 1, in the thigh on Day 8, and in the lower abdomen on Day 15 Receives: Combination Product: cotadutide multidose pen injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration time curve
To evaluate exposure following a single subcutaneous dose of cotadutide at each of 3 different sites of injection.
Measured: 48 hours
Secondary outcomes (7)
Maximum observed plasma drug concentration
To evaluate exposure following a single subcutaneous dose of cotadutide at each of 3 different sites of injection.
Measured: 48 hours
Area under the plasma concentration time curve from zero to infinity
To evaluate exposure following a single subcutaneous dose of cotadutide at each of 3 different sites of injection
Measured: 48 hours
Time to maximum observed plasma drug concentration
To evaluate exposure following a single subcutaneous dose of cotadutide at each of 3 different sites of injection
Measured: 48 hours
Terminal phase elimination half life
To evaluate exposure following a single subcutaneous dose of cotadutide at each of 3 different sites of injection
Measured: 48 hours
Apparent clearance
To evaluate exposure following a single subcutaneous dose of cotadutide at each of 3 different sites of injection.
Measured: 48 hours
Anti drug antibody incidence and titer
To evaluate the immunogenicity of a single subcutaneous dose of cotadutide at each of 3 different sites of injection
Measured: 43 Days
Incidence of treatment-emergent adverse events, including those related to changes in vital signs (including body temperature, heart rate, blood pressure) and safety laboratory evaluations (including hematology, chemistry, plasma glucose, urinalysis).
To evaluate the safety and tolerability of a single subcutaneous dose of cotadutide at each of 3 different sites of injection.
Measured: 43 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start27 Sep 2019
- Primary completion6 Mar 2020
- Study completion6 Mar 2020
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
- 36 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
- NCT04091373
- Sponsor's protocol ID
- D5670C00025
- Status last verified
- Apr 2020
- First submitted
- 28 Aug 2019
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-label, Single Center, Three Period Cross-over Study to Evaluate the Pharmacokinetics of Single Dose Administration of Cotadutide in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04091373
- Acronym / sponsor ID
- D5670C00025
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 16 Sep 2019 (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 study in healthy adult subjects to investigate cotadutide exposure after subcutaneous injection at 3 different anatomical sites. The study will be conducted at a single US center. Each subject will be randomized to receive a single SC dose of 100 μg cotadutide via a pen device according to 6 sequences of dosing. Each SC injection will be administered by a health care provider at a different injection site (arm, thigh, or abdomen) in each period. SC injection in the abdomen will be used as the reference treatment to determine the relative PK of cotadutide 100 μg SC injections in the arm and thigh. Each SC injection of cotadutide will be separated by 7 days washout. Blood samples for PK analyses of cotadutide will be taken pre dose and at 11 time points up to 48 hours after dosing (Days 3, 10, and 17).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Combination Product: cotadutide multidose pen injection100ug SC injection cotadutide in the upper arm on Day 1, in the lower abdomen on Day 8, and in the thigh on Day 15 |
| Sequence 2 | Experimental | Combination Product: cotadutide multidose pen injection100ug SC injection cotadutide in the thigh on Day 1, in the upper arm on Day 8, and in the lower abdomen on Day 15 |
| Sequence 3 | Experimental | Combination Product: cotadutide multidose pen injection100ug SC injection cotadutide in the lower abdomen on Day 1, in the thigh on Day 8, and in the upper arm on Day 15 |
| Sequence 4 | Experimental | Combination Product: cotadutide multidose pen injection100ug SC injection cotadutide in the thigh on Day 1, in the lower abdomen on Day 8, and in the upper arm on Day 15 |
| Sequence 5 | Experimental | Combination Product: cotadutide multidose pen injection100ug SC injection cotadutide in the lower abdomen on Day 1, in the upper arm on Day 8, and in the thigh on Day 15 |
| Sequence 6 | Experimental | Combination Product: cotadutide multidose pen injection100ug SC injection cotadutide in the upper arm on Day 1, in the thigh on Day 8, and in the lower abdomen on Day 15 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy subjects aged 18 through 60 years (inclusive) at the time of screening.
- Electronic and/or written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- BMI 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 electrocardiogram (ECG), vital signs, and blood and urinary laboratory assessments.
- Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of investigational product, and must not be breastfeeding.
Key exclusion criteria (22 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 interpretation of subject safety or study results.
- Inflammatory bowel disease, gastroparesis or other severe disease or surgery affecting the upper GI tract, which may affect gastric emptying or could affect the interpretation of safety and tolerability data.
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2; eGFR will be determined by the chronic kidney disease - epidemiology collaboration (CKD-EPI) equation.
- BP 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.
- Active hepatitis B, measured by positive tests of surface antigen HBsAg and/or active hepatitis C, measured by positive hepatitis C virus antibody tests.
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 |
|---|---|---|
| cotadutide multidose pen injectionSC injection in the upper arm | Combination product | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| cotadutide multidose pen injectionSC injection in the lower abdomen | Combination product | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| cotadutide multidose pen injectionSC injection in the thigh | Combination product | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
Area under the plasma concentration time curve
Time frame: 48 hours
To evaluate exposure following a single subcutaneous dose of cotadutide at each of 3 different sites of injection.
7 secondary outcomes
Maximum observed plasma drug concentration
Time frame: 48 hours
Area under the plasma concentration time curve from zero to infinity
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
Anti drug antibody incidence and titer
Time frame: 43 Days
Incidence of treatment-emergent adverse events, including those related to changes in vital signs (including body temperature, heart rate, blood pressure) and safety laboratory evaluations (including hematology, chemistry, plasma glucose, urinalysis).
Time frame: 43 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 7 Apr 2020.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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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 cotadutide multidose pen injection 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 22 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 7 Apr 2020. 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 plasma concentration time curve (time frame: 48 hours). 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 7 Apr 2020.