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

Phase 1CompletedNCT02320045

Intarcia Therapeutics38 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Insufficiency

Interventions

ITCA 650 (Exenatide in osmotic mini pump)DRUG

Eligibility

Sex: ALLMin age: 25 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Intarcia Therapeutics Inc.

Boston, Massachusetts, United States

Study Site

Kiel, Germany

Study Site

Mannheim, Germany

Study Site

Mönchengladbach, Germany