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

Renal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02320045
• Other study ID #: ITCA 650 CLP-109
• Status: Completed
• Phase: Phase 1
• First received: November 26, 2014
• Last updated: June 2, 2016
• Start date: November 2014
• Est. completion date: July 2015

Study information

• Verified date: June 2016
• Source: Intarcia Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

Drug:
• ITCA 650 (Exenatide in osmotic mini pump)

Locations

Country	Name	City	State
Germany	Study Site	Kiel
Germany	Study Site	Mannheim
Germany	Study Site	Moenchengladbach
United States	Intarcia Therapeutics Inc.	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Intarcia Therapeutics

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-h Area under the Curve at steady state (AUCt,ss)		Approximately 67 Days	No
Secondary	Rate of adverse events		Approximately 67 Days	No
Secondary	Severity of adverse events		Approximately 67 Days	No
Secondary	Safety laboratory parameters		Approximately 67 Days	No
Secondary	Vital signs		Approximately 67 Days	No
Secondary	Electrocardiogram		Approximately 67 Days	No
Secondary	Physical exam		Approximately 67 Days	No