Study to Evaluate Pharmacokinetics of ITCA 650 in Subjects With Renal Impairment Compared to Normal Subjects

June 2, 2016 updated by: Intarcia Therapeutics

A Phase 1 Study to Evaluate the Pharmacokinetics of ITCA 650 in Subjects With Mild and Moderate Renal Impairment Compared to the Pharmacokinetics of Subjects With Normal Renal Function

A Phase 1 study to evaluate the pharmacokinetics of ITCA 650 in subjects with mild and moderate renal impairment compared to the pharmacokinetics of subjects with normal renal function

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Kiel, Germany
        • Study Site
      • Mannheim, Germany
        • Study Site
      • Moenchengladbach, Germany
        • Study Site
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02210
        • Intarcia Therapeutics Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index between 22 and 40 kg/m²

  • Subjects meeting pre-defined estimated glomerular filtration rate criteria and creatinine clearance rate

    • Normal (≥90 mL/min/1.73 m2)
    • Mild (60-89 mL/min/1.73 m2)
    • Moderate (45-59 mL/min/1.73 m2)
    • Moderate (>30-44 mL/min/1.73 m2)

Exclusion Criteria:

  • History of acute metabolic complications
  • Uncontrolled Hypertension
  • History of Hypersensitivity to Exenatide
  • Cardiovascular Disease
  • History of Acute or chronic pancreatitis
  • Personal or family history of Multiple endocrine neoplasia type 2
  • History of Medullary thyroid cancer
  • Severe renal failure, End stage renal disease or dialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Normal
Normal Subjects estimated creatinine clearance (eGFR) ≥90 mL/min/1.73 m2
Drug: ITCA 650 (Exenatide in osmotic mini pump)
Experimental: Group 2: Mild Renal Dysfunction
Subjects with Mild Renal Dysfunction estimated creatinine clearance (eGFR) 60-89 mL/min/1.73 m2
Drug: ITCA 650 (Exenatide in osmotic mini pump)
Experimental: Goup 3: Moderate Renal Dysfunction
Subjects with Moderate Renal Dysfunction estimated creatinine clearance (eGFR) 45-59 mL/min/1.73 m2
Drug: ITCA 650 (Exenatide in osmotic mini pump)
Experimental: Group 4: Moderate Renal Dysfunction
Subjects with Moderate Renal Dysfunction estimated creatinine clearance (eGFR) >30-44 mL/min/1.73 m2
Drug: ITCA 650 (Exenatide in osmotic mini pump)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
24-h Area under the Curve at steady state (AUCt,ss)
Time Frame: Approximately 67 Days
Approximately 67 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of adverse events
Time Frame: Approximately 67 Days
Approximately 67 Days
Severity of adverse events
Time Frame: Approximately 67 Days
Approximately 67 Days
Safety laboratory parameters
Time Frame: Approximately 67 Days
Approximately 67 Days
Vital signs
Time Frame: Approximately 67 Days
Approximately 67 Days
Electrocardiogram
Time Frame: Approximately 67 Days
Approximately 67 Days
Physical exam
Time Frame: Approximately 67 Days
Approximately 67 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intarcia Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

November 26, 2014

First Submitted That Met QC Criteria

December 15, 2014

First Posted (Estimate)

December 19, 2014

Study Record Updates

Last Update Posted (Estimate)

June 3, 2016

Last Update Submitted That Met QC Criteria

June 2, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITCA 650 CLP-109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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