Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00008819

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00008819
  •   2015/08/12
  •   2014/11/26
  •   no
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Secondary IDs

  •   NCT02320045  (ClinicalTrials.gov)
  •   ITCA 650 CLP-109  (Intarcia Therapeutics)
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Health Condition or Problem studied

  •   Renal Insufficiency
  •   N19 -  Unspecified kidney failure
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Interventions/Observational Groups

  •   Drug: ITCA 650 (Exenatide in osmotic mini pump)
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Treatment
  •   Parallel
  •   I
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Primary Outcome

- 24-h Area under the Curve at steady state (AUCt,ss); time frame: Approximately 67 Days

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Secondary Outcome

- Rate of adverse events; time frame: Approximately 67 Days
- Severity of adverse events; time frame: Approximately 67 Days
- Safety laboratory parameters; time frame: Approximately 67 Days
- Vital signs; time frame: Approximately 67 Days
- Electrocardiogram; time frame: Approximately 67 Days
- Physical exam; time frame: Approximately 67 Days

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Countries of Recruitment

  •   United States
  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2014/11/30
  •   40
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   25   Years
  •   80   Years
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Additional 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)

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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

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Addresses

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    • Intarcia Therapeutics
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    • Michelle Baron, MD, FACE 
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    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Michelle Baron, MD, FACE 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2015/06/17
* This entry means the parameter is not applicable or has not been set.