NCT03235375

Brief Summary

A phase 1 open-label, single-dose study to evaluate the pharmacokinetics (PK), safety, tolerability and immunogenicity of MEDI0382 in subjects with renal impairment.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_1

Geographic Reach
2 countries

4 active sites

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

July 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

October 27, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2018

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

6 months

First QC Date

July 27, 2017

Last Update Submit

April 30, 2018

Conditions

Renal Insufficiency

Keywords

Kidney Failure, Kidney Insufficiency, Renal Failure, Renal Insufficiency, MEDI0382

Outcome Measures

Primary Outcomes (2)

  • Maximum Observed Concentration of MEDI0382 (Cmax)

    The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data

    0-48 hours

  • Area under the Concentration Time Curve (AUC) of MEDI0382

    The area under the plasma concentration-time curve to 48 hours concentration determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations

    0-48 hours

Secondary Outcomes (8)

  • Time to maximum observed concentration (Tmax)

    0-48 hours

  • apparent clearance (Cl/F)

    0-48 hours

  • AUCinf

    0-48 hours

  • Half-life (T1/2)

    0-48 hours

  • Anti-drug Antibody (ADA) titer

    Day -1 to day 28

  • +3 more secondary outcomes

Study Arms (4)

Group 1: End Stage Renal Disease (ESRD)

EXPERIMENTAL

Subjects with CrCl \<20ml/min will receive MEDI0382 administered subcutaneously

Drug: MEDI0382

Group 2: Severe and ESRD Subjects

EXPERIMENTAL

Subjects with CrCl \>20 and \< 30 ml/min will receive MEDI0382 administered subcutaneously

Drug: MEDI0382

Group 3: Healthy Subjects

ACTIVE COMPARATOR

Subjects with CrCl \>90 ml/min will receive MEDI0382 administered subcutaneously

Drug: MEDI0382

Group 4: Moderate Renal Disease

EXPERIMENTAL

Subjects with CrCl \> or equal to 30 and \< 60 mL/min will receive MEDI0382 administered subcutaneously

Drug: MEDI0382

Interventions

MEDI0382DRUG

MEDI0382 administered subcutaneously

Group 1: End Stage Renal Disease (ESRD)Group 2: Severe and ESRD SubjectsGroup 3: Healthy SubjectsGroup 4: Moderate Renal Disease

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must provide written informed consent
  • BMI greater than or equal to 17 and less than or equal to 40 kg/m2
  • Creatinine clearance rate greater than or equal to 90 (healthy); or renally impaired (less than 60 mL/min)
  • Females of childbearing potential must use a highly effective form of contraception.

You may not qualify if:

  • Any history of or concurrent condition that in the opinion of the investigator would compromise the subjects safety.
  • Subjects on dialysis
  • Subjects with pancreatitis
  • Renal transplant subjects
  • Females pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

Kiel, 24105, Germany

Location

Research Site

München, 81241, Germany

Location

Research Site

Auckland, 1010, New Zealand

Location

Research Site

Christchurch, 8011, New Zealand

Location

Related Publications (1)

  • Klein G, Petrone M, Yang Y, Hoang T, Hazlett S, Hansen L, Flor A. Pharmacokinetics and Safety of Cotadutide, a GLP-1 and Glucagon Receptor Dual Agonist, in Individuals with Renal Impairment: A Single-Dose, Phase I, Bridging Study. Clin Pharmacokinet. 2023 Jun;62(6):881-890. doi: 10.1007/s40262-023-01239-1. Epub 2023 May 4.

    PMID: 37140727DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

cotadutide

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2017

First Posted

August 1, 2017

Study Start

October 27, 2017

Primary Completion

April 24, 2018

Study Completion

April 24, 2018

Last Updated

May 1, 2018

Record last verified: 2018-04

Locations

DE(2)NZ(2)