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

Intarcia Therapeutics

Status and phase: Completed; Phase 1

Conditions: Renal Insufficiency

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02320045

ITCA 650 CLP-109

Details and patient eligibility

About

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

Enrollment: 38 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 4 patient groups

Group 1: Normal

Experimental group

Description:

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

Treatment:

Drug: ITCA 650 (Exenatide in osmotic mini pump)

Group 2: Mild Renal Dysfunction

Experimental group

Description:

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

Treatment:

Drug: ITCA 650 (Exenatide in osmotic mini pump)

Goup 3: Moderate Renal Dysfunction

Experimental group

Description:

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

Treatment:

Drug: ITCA 650 (Exenatide in osmotic mini pump)

Group 4: Moderate Renal Dysfunction

Experimental group

Description:

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

Treatment:

Drug: ITCA 650 (Exenatide in osmotic mini pump)