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Completed

NCT Number: NCT02320045

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

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

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Key information

Conditions

Renal Insufficiency Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Study Site, Kiel, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ITCA 650 (Exenatide in osmotic mini pump)

Drug

Primary outcomes

  1. 24-h Area under the Curve at steady state (AUCt,ss)

    Time frame: Approximately 67 Days

Secondary outcomes

  1. Rate of adverse events

    Time frame: Approximately 67 Days

  2. Severity of adverse events

    Time frame: Approximately 67 Days

  3. Safety laboratory parameters

    Time frame: Approximately 67 Days

  4. Vital signs

    Time frame: Approximately 67 Days

  5. Electrocardiogram

    Time frame: Approximately 67 Days

  6. Physical exam

    Time frame: Approximately 67 Days

Sponsors and collaborators

Lead sponsor

Intarcia Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 19, 2014
Registry last updated
Jun 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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