Healthy VolunteersPhase 1NCT03347968
Study to Compare Pharmacokinetics & Pharmacodynamics of Warfarin & Esmolol in the Absence & Presence of MEDI0382
A Phase 1 study testing MEDI0382, Warfarin and Esmolol in people with Healthy Volunteers, run by MedImmune LLC at 1 site in United States.
Trial summary
A Phase 1 study to evaluate the effect of MEDI0382 on PK and PD of warfarin and esmolol in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MEDI0382, Warfarin and Esmolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2017to 9 Apr 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 volunteers aged ≥ 18 to 45 years
- BMI between 18 -30 kg/m2
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception
Who cannot join
- Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
- Receipt of investigational product as part of a clinical study or a GLP-1 analogue containing preparation within the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening.
- Concurrent participation in another study of any kind
- Severe allergy/hypersensitivity to any of the proposed study treatments or excipients.
- History or presence of gastrointestinal (GI), hepatic, or renal disease or any other conditions known to interfere with absorption, distribution, metabolism or excretion of drugs.
- Impaired renal function is defined as estimated glomerular filtration rate (eGFR) < 60 mL/minute/1.73 m2 at screening.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of screening.
- History of hemophilia, von Willebrand's disease, lupus anticoagulant, or other diseases/syndromes that can either alter or increase the propensity for bleeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Study to Compare the Pharmacokinetics and Pharmacodynamics of Warfarin and Esmolol in the Absence and Presence of MEDI0382 in Healthy Subjects
A Phase 1 study to evaluate the effect of MEDI0382 on PK and PD of warfarin and esmolol in healthy subjects.
Read the detailed description
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.
- Conditions
- Healthy Volunteers
- Being tested
- MEDI0382, Warfarin, Esmolol
- Keywords
- type 2 Diabetes Mellitus, MEDI0382
- 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.
MEDI0382Biological
All participants will receive MEDI0382
WarfarinDrug
All participants will receive Warfarin
EsmololDrug
All participants will receive Esmolol
| Study group | Role | What they receive |
|---|---|---|
| MEDI0382 | Experimental | All participants will receive MEDI0382. Receives: Biological: MEDI0382 |
| Warfarin | Active comparator | All participants will receive Warfarin Receives: Drug: Warfarin |
| Esmolol | Active comparator | All participants will receive Esmolol Receives: Drug: Esmolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum international normalized ratio (INRmax)
To assess the INR max in the absence and presence of Warfarin on a steady state MEDI0382
Measured: 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.
Measured: 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
Measured: Days 2-8 and Days 27-33
Secondary outcomes (10)
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
Measured: 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
Measured: Days 2 and 27
Number of patients with Adverse Events (AEs)
To assess the adverse events as a criteria of safety and tolerability variables.
Measured: 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.
Measured: 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.
Measured: Days 1 and 33
Clinical laboratory assessments (hematology)
To assess hematology as a criteria of safety and tolerability variables..
Measured: Days 1 and 33
Vital signs (systolic and diastolic blood pressure)
To assess the vital signs as a criteria of safety and tolerability variables
Measured: 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
Measured: 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.
Measured: 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.
Measured: Day -1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start27 Nov 2017
- Primary completion9 Apr 2018
- Study completion9 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Armando Flor, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347968
- Sponsor's protocol ID
- D5670C00009
- Status last verified
- Apr 2018
- First submitted
- 16 Oct 2017
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Compare the Pharmacokinetics and Pharmacodynamics of Warfarin and Esmolol in the Absence and Presence of MEDI0382 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03347968
- Acronym / sponsor ID
- D5670C00009
- Conditions
- Healthy Volunteers
- Keywords
- type 2 Diabetes Mellitus, MEDI0382
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 9 Apr 2018 (actual)
- First posted
- 20 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.
A Phase 1 study to evaluate the effect of MEDI0382 on PK and PD of warfarin and esmolol in healthy subjects.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MEDI0382 | Experimental | Biological: MEDI0382All participants will receive MEDI0382. |
| Warfarin | Active comparator | Drug: WarfarinAll participants will receive Warfarin |
| Esmolol | Active comparator | Drug: EsmololAll participants will receive Esmolol |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteers aged ≥ 18 to 45 years
- BMI between 18 -30 kg/m2
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception
Key exclusion criteria (8 listed)
- Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
- Receipt of investigational product as part of a clinical study or a GLP-1 analogue containing preparation within the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening.
- Concurrent participation in another study of any kind
- Severe allergy/hypersensitivity to any of the proposed study treatments or excipients.
- History or presence of gastrointestinal (GI), hepatic, or renal disease or any other conditions known to interfere with absorption, distribution, metabolism or excretion of drugs.
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 |
|---|---|---|
| MEDI0382All participants will receive MEDI0382 | Biological | MEDI0382 |
| WarfarinAll participants will receive Warfarin | Drug | Warfarin |
| EsmololAll participants will receive Esmolol | Drug | Esmolol |
Primary outcome
Maximum international normalized ratio (INRmax)
Time frame: Days 2-8 and Days 27-33
To assess the INR max in the absence and presence of Warfarin on a steady state MEDI0382
Change in heart rate from resting after a 9-minute excercise treadmill test (Bruce Protocol, first 3 stages)
Time frame: Days 1 and 26
To assess the effects of MEDI0382 on the hear rate-lowering effect of esmolol during treadmill test.
Maximum international normalized ratio (INRmax)
Time frame: Days 2-8 and Days 27-33
To assess the AUC INR in the absence and presence of Warfarin on a steady state MEDI0382
10 secondary outcomes
PK(AUC) of R-Warfarin and S-Warfarin
Time frame: Days 2 and 27
PK (Cmax) of R-Warfarin and S-Warfarin
Time frame: Days 2 and 27
Number of patients with Adverse Events (AEs)
Time frame: 33 Days
12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals
Time frame: Day 1, Day 8, Day 13, and Day 18
Anti-drug antibody titer incidence
Time frame: Days 1 and 33
Clinical laboratory assessments (hematology)
Time frame: Days 1 and 33
Vital signs (systolic and diastolic blood pressure)
Time frame: Days 1-8, Days 12 and 13, Days 25-33
Vital signs (pulse rate and respiratory rate
Time frame: Days 1-8, Days 12 and 13, Days 25-33
Clinical laboratory assessments (serum chemistry)
Time frame: Day -1, Day 8, Day 17, Day 25 and Day 33
Clinical laboratory assessment (urinalysis)
Time frame: Day -1
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 25 Apr 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.
Armando Flor study director
MedImmune LLC
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, Warfarin and Esmolol in people with Healthy Volunteers, 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 3 inclusion and 8 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 25 Apr 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?
Maximum international normalized ratio (INRmax) (time frame: Days 2-8 and Days 27-33). The study lists 3 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 25 Apr 2018.