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

Phase 1

Completed

• Conditions: Renal Insufficiency
• Interventions: Drug: ITCA 650 (Exenatide in osmotic mini pump)

• Registration Number: NCT02320045
• Lead Sponsor: Intarcia Therapeutics

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-26
• Study First Submitted QC: 2014-12-15
• Study First Posted: 2014-12-19
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-02
• Last Update Posted: 2016-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
24-h Area under the Curve at steady state (AUCt,ss)	Approximately 67 Days

Secondary Outcome Measures

Name	Time	Method
Safety laboratory parameters	Approximately 67 Days
Vital signs	Approximately 67 Days
Rate of adverse events	Approximately 67 Days
Severity of adverse events	Approximately 67 Days
Physical exam	Approximately 67 Days
Electrocardiogram	Approximately 67 Days

Trial Locations

Locations (2)

Intarcia Therapeutics Inc.; 🇺🇸 Boston, Massachusetts, United States

Study Site; 🇩🇪 Moenchengladbach, Germany