NCT03347968

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

November 27, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2018

Completed
Last Updated

April 25, 2018

Status Verified

April 1, 2018

Enrollment Period

4 months

First QC Date

October 16, 2017

Last Update Submit

April 24, 2018

Conditions

Healthy Volunteers

Keywords

type 2 Diabetes Mellitus, MEDI0382

Outcome Measures

Primary Outcomes (3)

  • Maximum international normalized ratio (INRmax)

    To assess the INR max in the absence and presence of Warfarin on a steady state MEDI0382

    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.

    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

    Days 2-8 and Days 27-33

Secondary Outcomes (10)

  • PK(AUC) of R-Warfarin and S-Warfarin

    Days 2 and 27

  • PK (Cmax) of R-Warfarin and S-Warfarin

    Days 2 and 27

  • Number of patients with Adverse Events (AEs)

    33 Days

  • 12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals

    Day 1, Day 8, Day 13, and Day 18

  • Anti-drug antibody titer incidence

    Days 1 and 33

  • +5 more secondary outcomes

Study Arms (3)

MEDI0382

EXPERIMENTAL

All participants will receive MEDI0382.

Biological: MEDI0382

Warfarin

ACTIVE COMPARATOR

All participants will receive Warfarin

Drug: Warfarin

Esmolol

ACTIVE COMPARATOR

All participants will receive Esmolol

Drug: Esmolol

Interventions

MEDI0382BIOLOGICAL

All participants will receive MEDI0382

MEDI0382
WarfarinDRUG

All participants will receive Warfarin

Warfarin
EsmololDRUG

All participants will receive Esmolol

Esmolol

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

cotadutideWarfarinesmolol

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Armando Flor

    MedImmune LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2017

First Posted

November 20, 2017

Study Start

November 27, 2017

Primary Completion

April 9, 2018

Study Completion

April 9, 2018

Last Updated

April 25, 2018

Record last verified: 2018-04

Locations

US(1)