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Feasibility Study of Exenatide by Continuous Subcutaneous Infusion

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ClinicalTrials.gov Identifier: NCT01857895
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : October 19, 2017
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This is an open-label study to investigate the feasibility of administering exenatide by continuous subcutaneous infusion to healthy subjects. Study will consist of two parts i.e. Part A and B. In Part A 2 healthy subjects will receive exenatide infusion over 24 hours followed by a follow-up visit 10 to 14 days after discharge from clinic. In Part B approximately 6 healthy subjects will receive subcutaneous infusions of exenatide for maximum of 7 days followed by a follow-up visit 10 to 14 days after discharge from clinic.

Condition or disease Intervention/treatment Phase
Obesity Drug: Exenatide Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Exploratory Study to Investigate the Feasibility of Administering Exenatide by Continuous Subcutaneous Infusion to Healthy Subjects
Actual Study Start Date : May 16, 2013
Actual Primary Completion Date : November 1, 2013
Actual Study Completion Date : November 1, 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arm Intervention/treatment
Experimental: Exenatide infusion in Part A
Subjects in Part A will receive exenatide as a subcutaneous infusion at a constant rate for 24 hours.
Drug: Exenatide
Prefilled pen containing 2.4 mL of drug will be transferred into MiniMed Paradigm Real-Time Revel device for subcutaneous infusion.

Experimental: Exenatide infusion in Part B
Subjects in Part B will receive exenatide with daily increases in the infusion rate.
Drug: Exenatide
Prefilled pen containing 2.4 mL of drug will be transferred into MiniMed Paradigm Real-Time Revel device for subcutaneous infusion.




Primary Outcome Measures :
  1. Characterization of interruptions or deviations from prescribed exenatide infusion in Part A [ Time Frame: 2 days ]
    To investigate the feasibility of administering exenatide via continuous subcutaneous infusion

  2. Characterization of interruptions or deviations from prescribed exenatide infusion in Part B [ Time Frame: 8 days ]
    To investigate the feasibility of administering exenatide via continuous subcutaneous infusion

  3. Infusion rate adjustments when nausea/vomiting occurs in Part B [ Time Frame: 8 days ]
    To investigate the feasibility of administering exenatide via continuous subcutaneous infusion. Infusion rate adjustment will be done to achieve tolerable infusion rate when nausea/vomiting occurs

  4. Number of participants with adverse events (AEs) in Part A [ Time Frame: 17 days ]
    AEs will be collected from the Day -1 and until the follow-up contact. AE data will be collected to evaluate the ability to monitor and maintain acceptable safety

  5. Number of participants with AEs in Part B [ Time Frame: 23 days ]
    AEs will be collected from the Day -1 and until the follow-up contact. AE data will be collected to evaluate the ability to monitor and maintain acceptable safety

  6. Laboratory parameter assessment in Part A [ Time Frame: 17 days ]
    Laboratory parameters include: hematology, clinical chemistry, and urinalysis

  7. Laboratory parameter assessment in Part B [ Time Frame: 23 days ]
    Laboratory parameters include: hematology, clinical chemistry, and urinalysis

  8. Vital sign assessment in Part A [ Time Frame: 17 days ]
    Vital signs measurement include: systolic and diastolic blood pressure, and pulse rate

  9. Vital sign assessment in Part B [ Time Frame: 23 days ]
    Vital signs measurement include: systolic and diastolic blood pressure, and pulse rate


Secondary Outcome Measures :
  1. Pharmacokinetic (PK) profile of exenatide in Part A [ Time Frame: PK samples will be collected at pre-dose, and at 0.5, 1, 2, 4, 6, 10, 14, 24, and 26 hours post dose. ]
    PK parameters include: area under concentration time curve from time 0 to 24 hours (AUC0 to24), maximum observed concentration from time 0 to 24 hours (Cmax0 to 24), and average concentration from time 0 to 24 hours (Cavg0 to 24) versus time

  2. Pharmacokinetic (PK) profile of exenatide in Part B [ Time Frame: 8 days ]
    PK parameters include: AUC0-24, Cmax0 to 24, and Cavg0 to 24 versus time for each of 7 days and AUC0 to 168, Cmax0 to 168, and Cavg0 to 168 versus time over entire infusion period.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Male/females aged between 18 and 60 years of age inclusive, at the time of signing the informed consent.
  • Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and 12-lead ECG. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator agrees and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures and objectives.
  • Body Mass Index within the range 18 to 35 kilograms/meter squared (kg/m^2) inclusive.
  • A female subject is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. In questionable cases a blood sample with simultaneous follicle stimulating hormone > 40 milli international unit/mililiter (mL) and estradiol <40 picogram/mL (<147 picomoles/Liter) is confirmatory. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.
  • Child-bearing potential females must agree to use one of the contraception methods. This criterion must be followed from the time of the first dose of study medication until follow up visit.
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Based on QT interval corrected for heart rate (QTc) of single electrocardiogram (ECG): QTc by Fridericia's formula <450 millisecond (msec).
  • Aspartate aminotransferase and Alanine aminotransferase <2x upper limit of normal (ULN); alkaline phosphatase and bilirubin <= 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

Exclusion Criteria

  • Subjects with a personal or family history of thyroid carcinoma or Type 2 Familial Endocrine Neoplasia.
  • History of uncorrected thyroid dysfunction or an abnormal thyroid functions as assessed by thyroid stimulating hormones.
  • Subjects with a history of severe gastrointestinal disease, or abnormal renal function.
  • Subjects with previous exposure to a Glucagon-like peptide-1 mimetic.
  • History of chronic or acute pancreatitis. Note: Subjects with a lipase value above 1.5X ULN at screening are excluded.
  • Current or chronic history of liver disease, or hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 grams of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy.

Criteria Based Upon Diagnostic Assessments

  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
  • A positive pre-study drug/alcohol screen.
  • A subject with a positive urine cotinine test result will be excluded from the study unless in the judgment of the Investigator the subject will be able to abstain from using tobacco for the duration of the in-house period of the study.
  • A positive test for human immuno virus antibody.

Other Criteria

  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857895


Locations
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United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
GlaxoSmithKline
Parexel
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 200016
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 200016
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 200016
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 200016
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 200016
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 200016
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 200016
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01857895    
Other Study ID Numbers: 200016
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Keywords provided by GlaxoSmithKline:
Nausea
subcutaneous infusion
exenatide
Additional relevant MeSH terms:
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Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists