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A Study to Evaluate Pharmacokinetics, Safety and Tolerability of MEDI0382 in Renal Impairment Subjects

NCT ID: NCT03235375

Last Updated: 2018-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-27

Study Completion Date

2018-04-24

Brief Summary

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

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Detailed Description

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This is an open-label, single-dose, parallel group study to evaluate the PK, safety, tolerability, and immunogenicity of MEDI0382 in subjects with renal impairment. Enrollment of approximately 40 subjects across multiple sites is planned. Subjects will be divided into 4 groups based on renal function.

Conditions

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Renal Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group 1: End Stage Renal Disease (ESRD)

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

Group Type EXPERIMENTAL

MEDI0382

Intervention Type DRUG

MEDI0382 administered subcutaneously

Group 2: Severe and ESRD Subjects

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

Group Type EXPERIMENTAL

MEDI0382

Intervention Type DRUG

MEDI0382 administered subcutaneously

Group 3: Healthy Subjects

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

Group Type ACTIVE_COMPARATOR

MEDI0382

Intervention Type DRUG

MEDI0382 administered subcutaneously

Group 4: Moderate Renal Disease

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

Group Type EXPERIMENTAL

MEDI0382

Intervention Type DRUG

MEDI0382 administered subcutaneously

Interventions

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MEDI0382

MEDI0382 administered subcutaneously

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedImmune LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Kiel, , Germany

Site Status

Research Site

München, , Germany

Site Status

Research Site

Auckland, , New Zealand

Site Status

Research Site

Christchurch, , New Zealand

Site Status

Countries

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Germany New Zealand

References

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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.

Reference Type DERIVED
PMID: 37140727 (View on PubMed)

Other Identifiers

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D5670C00008

Identifier Type: -

Identifier Source: org_study_id

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