NCT02394314

Brief Summary

A Phase 1, single dose study with 8 cohorts of ascending doses designed to evaluate the safety and pharmacokinetics of MEDI0382 in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
362

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Feb 2015

Typical duration for phase_1 healthy-volunteers

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

Study Start

First participant enrolled

February 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

6 months

First QC Date

February 26, 2015

Last Update Submit

September 8, 2015

Conditions

Healthy Volunteers

Keywords

MEDI0382, diabetes

Outcome Measures

Primary Outcomes (5)

  • Number of subjects with adverse events as a measure of safety and tolerability of MEDI0382

    Treatment emergent adverse events (TEAEs) and serious adverse events (STEAEs)

    28 days post dosing

  • Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382

    GI symptomatology (a composite of nausea and vomiting)

    28 days post dosing

  • Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382

    Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rate)

    28 days post dosing

  • Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382

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

    28 days post dosing

  • Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382

    Clinical laboratory assessments (serum chemistry, hematology, urinalysis)

    28 days post dosing

Secondary Outcomes (3)

  • Pharmacokinetics of MEDI0382, maximum plasma concentration (Cmax)

    72 hours postdose

  • Pharmacokinetics of MEDI0382, area under the curve concentration (AUC)

    72 hours post dose

  • Proportion of subjects with ADA to MEDI0382

    28 days post dose

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo administered subcutaneously

Drug: Placebo

MEDI0382

EXPERIMENTAL

MEDI0382 administered subcutaneously

Drug: MEDI0382

Interventions

MEDI0382DRUG

MEDI0382 administered subcutaneously

MEDI0382
PlaceboDRUG

Placebo administered subcutaneously

Placebo

Eligibility Criteria

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

You may qualify if:

  • Healthy Volunteers, ages 18-45
  • Must provide written informed consent
  • BMI \>22 and \<30 kg/m2 and body weight \>70kg
  • Venous access suitable for multiple cannulations
  • Vital signs within normal specified ranges
  • Females must be non-lactating and non-childbearing potential
  • Males must practice 2 effective contraceptive measures if sexually active

You may not qualify if:

  • Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
  • History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
  • History of cancer, with the exception of non-melanoma skin cancer
  • Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing
  • Positive Hepatitis B, Hepatitis C or HIV test or use of antiretroviral medications at screening.
  • Concurrent or previous use of a GLP-1 receptor agonist
  • Current or previous use of systemic corticosteroids within the past 28 days prior to screening
  • Use of any medicinal products or herbal preparations licensed for control of body weight or appetite is prohibited.
  • Known or suspected history of alcohol or drug abuse within the past 3 years.
  • Positive drug screen
  • Current smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Berlin, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

cotadutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2015

First Posted

March 20, 2015

Study Start

February 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 9, 2015

Record last verified: 2015-09

Locations

DE(1)