Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 54 of 226 for:    warfarin AND International

Study to Compare Pharmacokinetics & Pharmacodynamics of Warfarin & Esmolol in the Absence & Presence of MEDI0382

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03347968
Recruitment Status : Completed
First Posted : November 20, 2017
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Brief Summary:
A Phase 1 study to evaluate the effect of MEDI0382 on PK and PD of warfarin and esmolol in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Biological: MEDI0382 Drug: Warfarin Drug: Esmolol Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 27, 2017
Actual Primary Completion Date : April 9, 2018
Actual Study Completion Date : April 9, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: MEDI0382
All participants will receive MEDI0382.
Biological: MEDI0382
All participants will receive MEDI0382

Active Comparator: Warfarin
All participants will receive Warfarin
Drug: Warfarin
All participants will receive Warfarin

Active Comparator: Esmolol
All participants will receive Esmolol
Drug: Esmolol
All participants will receive Esmolol




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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


Secondary Outcome Measures :
  1. PK(AUC) of R-Warfarin and S-Warfarin [ Time Frame: Days 2 and 27 ]
    To assess AUC of R-warfarin and S-warfarin in the presence and absence of steady state MEDI0382

  2. PK (Cmax) of R-Warfarin and S-Warfarin [ Time Frame: Days 2 and 27 ]
    To assess Cmax of R-warfarin and S-warfarin in the presence and absence of steady state MEDI0382

  3. Number of patients with Adverse Events (AEs) [ Time Frame: 33 Days ]
    To assess the adverse events as a criteria of safety and tolerability variables.

  4. 12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals [ Time Frame: Day 1, Day 8, Day 13, and Day 18 ]
    To assess the cardiovascular system functioning as a criteria of safety and tolerability variables.

  5. Anti-drug antibody titer incidence [ Time Frame: Days 1 and 33 ]
    To evaluate the safety and tolerability of multiple doses of MEDI0382 in conjunction with Warfarin and Esmolol.

  6. Clinical laboratory assessments (hematology) [ Time Frame: Days 1 and 33 ]
    To assess hematology as a criteria of safety and tolerability variables..

  7. Vital signs (systolic and diastolic blood pressure) [ Time Frame: Days 1-8, Days 12 and 13, Days 25-33 ]
    To assess the vital signs as a criteria of safety and tolerability variables

  8. Vital signs (pulse rate and respiratory rate [ Time Frame: Days 1-8, Days 12 and 13, Days 25-33 ]
    To assess the vital signs as a criteria of safety and tolerability variables

  9. Clinical laboratory assessments (serum chemistry) [ Time Frame: Day -1, Day 8, Day 17, Day 25 and Day 33 ]
    To assess clinical chemistry as a criteria of safety and tolerability variables.

  10. Clinical laboratory assessment (urinalysis) [ Time Frame: Day -1 ]
    To assess urinalysis as a criteria of safety and tolerability variables.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:.

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347968


Locations
Layout table for location information
United States, Florida
Research Site
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
MedImmune LLC
Investigators
Layout table for investigator information
Study Director: Armando Flor MedImmune LLC

Layout table for additonal information
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT03347968     History of Changes
Other Study ID Numbers: D5670C00009
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MedImmune LLC:
type 2 Diabetes Mellitus, MEDI0382
Additional relevant MeSH terms:
Layout table for MeSH terms
Warfarin
Esmolol
Anticoagulants
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs