A Phase 1 interventional study of MEDI0382 and Warfarin in Healthy Volunteers, sponsored by MedImmune LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-25.
Sponsored by MedImmune LLC (part of AstraZeneca) · Phase 1, Interventional, and Treatment
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Among 15 studies testing cotadutide in Diabetes Mellitus, Type 2 — none open to participants now, none under way, none of them phase 3. cotadutide · Diabetes Mellitus, Type 2.
Among the 15 studies testing cotadutide in Diabetes Mellitus, Type 2, this one is the 11th largest by enrollment, is one of 4 that started in 2017, is one of 5 in phase 1, and was the 5th registered.
10,382 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,411 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →None of the 15 studies testing cotadutide in Diabetes Mellitus, Type 2 is open now. The open studies under Diabetes Mellitus, Type 2, anywhere →
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 205 take healthy volunteers.
This study: 18 Years to 45 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 10
First in 2015; this study’s year is marked. 4 started in 2017.
This study's enrollment of 22 is below the median of 80 across 8,359 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 41 across the 15 interventional studies. Of the 15 that completed or were terminated, 10 (67%) have results posted.
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15 of 15 have an industry lead sponsor. The 2 most frequent:
This study is registered under MedImmune LLC, one of the names counted as AstraZeneca. Under that name alone:
MedImmune LLC is the lead sponsor of 270 studies on the registry; none are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 29 (56%) have results posted.
345 studies in Diabetes Mellitus, Type 2 by AstraZeneca: 13 open now, 15 under way, 9 of them phase 3. Of 325 finished, 149 (46%) have results posted.
Among the 345 studies in Diabetes Mellitus, Type 2 by AstraZeneca, this one is the 252nd largest by enrollment of the 280 interventional ones that give a count, is one of 22 that started in 2017, is one of 86 in phase 1, and was the 289th registered.
AstraZeneca’s Diabetes Mellitus, Type 2 studies by the year they started, since 2001.
None of the studies under way reaches primary completion within a year.
Among the 15 studies testing cotadutide in Diabetes Mellitus, Type 2, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among AstraZeneca’s 345 in Diabetes Mellitus, Type 2:
This tab as a report to print or save as PDF → With an account.
A Phase 1 study to evaluate the effect of MEDI0382 on PK and PD of warfarin and esmolol in healthy subjects.
This is a Phase 1 open label, one-sequence, crossover study to evaluate the effect of MEDI0382 on PK and PD of warfarin and esmolol in healthy subjects. The safety and tolerability of MEDI0382 in combination with warfarin and esmolol will also be evaluated. Following screening, the study consists of 2 5-day inpatient stays followed by outpatient visits.
Inclusion Criteria:.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colors or preservatives.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colors or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will receive MEDI0382.
Biological: MEDI0382
All participants will receive Warfarin
Drug: Warfarin
All participants will receive Esmolol
Drug: Esmolol
Maximum international normalized ratio (INRmax)
To assess the INR max in the absence and presence of Warfarin on a steady state MEDI0382
Time frame: Days 2-8 and Days 27-33
Change in heart rate from resting after a 9-minute excercise treadmill test (Bruce Protocol, first 3 stages)
To assess the effects of MEDI0382 on the hear rate-lowering effect of esmolol during treadmill test.
Time frame: Days 1 and 26
Maximum international normalized ratio (INRmax)
To assess the AUC INR in the absence and presence of Warfarin on a steady state MEDI0382
Time frame: Days 2-8 and Days 27-33
PK(AUC) of R-Warfarin and S-Warfarin
To assess AUC of R-warfarin and S-warfarin in the presence and absence of steady state MEDI0382
Time frame: Days 2 and 27
PK (Cmax) of R-Warfarin and S-Warfarin
To assess Cmax of R-warfarin and S-warfarin in the presence and absence of steady state MEDI0382
Time frame: Days 2 and 27
Number of patients with Adverse Events (AEs)
To assess the adverse events as a criteria of safety and tolerability variables.
Time frame: 33 Days
12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals
To assess the cardiovascular system functioning as a criteria of safety and tolerability variables.
Time frame: Day 1, Day 8, Day 13, and Day 18
Anti-drug antibody titer incidence
To evaluate the safety and tolerability of multiple doses of MEDI0382 in conjunction with Warfarin and Esmolol.
Time frame: Days 1 and 33
Clinical laboratory assessments (hematology)
To assess hematology as a criteria of safety and tolerability variables..
Time frame: Days 1 and 33
Vital signs (systolic and diastolic blood pressure)
To assess the vital signs as a criteria of safety and tolerability variables
Time frame: Days 1-8, Days 12 and 13, Days 25-33
Vital signs (pulse rate and respiratory rate
To assess the vital signs as a criteria of safety and tolerability variables
Time frame: Days 1-8, Days 12 and 13, Days 25-33
Clinical laboratory assessments (serum chemistry)
To assess clinical chemistry as a criteria of safety and tolerability variables.
Time frame: Day -1, Day 8, Day 17, Day 25 and Day 33
Clinical laboratory assessment (urinalysis)
To assess urinalysis as a criteria of safety and tolerability variables.
Time frame: Day -1
Ran from Nov 2017 to primary completion in Apr 2018, 4 months.
Of 453 industry-sponsored phase 1 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 11. This study's 4 months is below that.
Counting every sponsor, half of 515 studies reached it within 6 months; a quarter within 2 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cotadutide