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

NCT ID: NCT02320045

Last Updated: 2016-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-07-31

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

Conditions

Renal Insufficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1: Normal

Normal Subjects estimated creatinine clearance (eGFR) ≥90 mL/min/1.73 m2

Group Type: EXPERIMENTAL

ITCA 650 (Exenatide in osmotic mini pump)

Intervention Type: DRUG

Group 2: Mild Renal Dysfunction

Subjects with Mild Renal Dysfunction estimated creatinine clearance (eGFR) 60-89 mL/min/1.73 m2

Group Type: EXPERIMENTAL

ITCA 650 (Exenatide in osmotic mini pump)

Intervention Type: DRUG

Goup 3: Moderate Renal Dysfunction

Subjects with Moderate Renal Dysfunction estimated creatinine clearance (eGFR) 45-59 mL/min/1.73 m2

Group Type: EXPERIMENTAL

ITCA 650 (Exenatide in osmotic mini pump)

Intervention Type: DRUG

Group 4: Moderate Renal Dysfunction

Subjects with Moderate Renal Dysfunction estimated creatinine clearance (eGFR) \>30-44 mL/min/1.73 m2

Group Type: EXPERIMENTAL

ITCA 650 (Exenatide in osmotic mini pump)

Intervention Type: DRUG

Interventions

ITCA 650 (Exenatide in osmotic mini pump)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Intarcia Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Intarcia Therapeutics Inc.

Boston, Massachusetts, United States

Study Site

Kiel, , Germany

Study Site

Mannheim, , Germany

Study Site

Mönchengladbach, , Germany

Countries

United States; Germany

Other Identifiers

ITCA 650 CLP-109

Identifier Type: -

Identifier Source: org_study_id