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Trial record 20 of 31 for:    Metreleptin

Pharmacokinetics of Leptin Administration During Fasting

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ClinicalTrials.gov Identifier: NCT00140205
Recruitment Status : Completed
First Posted : September 1, 2005
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Christos Mantzoros, Beth Israel Deaconess Medical Center

Brief Summary:
The purpose of this study will be to determine the correct dose of leptin, a natural hormone secreted by the fat cells, to give to people when they are fasting and also to determine whether giving leptin to a person when he or she is fasting will reverse the changes in hormone levels that occur with fasting.

Condition or disease Intervention/treatment Phase
Energy Deficiency Due to Short-term Fasting Drug: r-metHuLeptin Phase 1

Detailed Description:

Leptin is a newly-identified hormone secreted by fat cells under normal conditions that acts in the brain to decrease appetite and increase long term energy usage. Leptin levels usually go down when people are not eating for extended periods of time. Changes in metabolism and certain hormone levels also occur with fasting. By studying the pharmacokinetics of leptin administration, we can evaluate the changes of leptin levels in response to giving different doses of leptin as well as acute changes of other hormones in response to leptin levels. Investigations such as this one have important implications for the future therapeutic use of leptin, including determining the appropriate dose of leptin to use in future studies involving leptin administration.

Comparison: subjects receiving leptin at 3 different doses in the fed state compared to the fasting state


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pharmacokinetics of Leptin Administration During Fasting
Study Start Date : February 2001
Actual Primary Completion Date : June 2004
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Metreleptin

Arm Intervention/treatment
Experimental: Fed state or fasting state

1-day fed studies with administration of r-metHuLeptin at three different doses (0.01 mg/kg, 0.1 mg/kg, 0.3 mg/kg). All subjects participated in 3 studies in the fed condition (Part A) and 3 separate 72-hour fasting studies.

Intervention administered was-r-metreleptin in 3 different doses

Drug: r-metHuLeptin
r-metreleptin was given in 3 different dose in fed and fasting states
Other Name: Recombinant leptin




Primary Outcome Measures :
  1. Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg [ Time Frame: 3 DAY ]
    72-hour fasting Day 3 Leptin dose 0.01 mg/kg

  2. Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg [ Time Frame: 3 DAY ]
    72-hour fasting Day 3 Leptin dose 0.01 mg/kg

  3. Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg [ Time Frame: 3 DAY ]
    72-hour fasting Day 3 Leptin dose 0.01 mg/kg

  4. Leptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg [ Time Frame: 3 DAY ]
    72-hour fasting Day 3 Leptin dose 0.1 mg/kg

  5. Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg [ Time Frame: 3 DAY ]
    72-hour fasting Day 3 Leptin dose 0.1 mg/kg

  6. Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg [ Time Frame: 3 DAY ]
    72-hour fasting Day 3 Leptin dose 0.1 mg/kg

  7. Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg [ Time Frame: 3 DAY ]
    72-hour fasting Day 3 Leptin dose 0.3 mg/kg

  8. Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg [ Time Frame: 3 DAY ]
    72-hour fasting Day 3 Leptin dose 0.3 mg/kg

  9. Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg [ Time Frame: 3 DAY ]
    72-hour fasting Day 3 Leptin dose 0.3 mg/kg

  10. Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.3 mg/kg [ Time Frame: 1 DAY ]
    24-hour fed Leptin dose 0.3 mg/kg

  11. Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.3 mg/kg [ Time Frame: 1 DAY ]
    24-hour fed Leptin dose 0.3 mg/kg

  12. Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.3 mg/kg [ Time Frame: 1 DAY ]
    24-hour fed Leptin dose 0.3 mg/kg

  13. Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.01 mg/kg [ Time Frame: 1 DAY ]
    24-hour fed Leptin dose 0.01 mg/kg

  14. Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.01 mg/kg [ Time Frame: 1 DAY ]
    24-hour fed Leptin dose 0.01 mg/kg

  15. Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.01 mg/kg [ Time Frame: 1 DAY ]
    24-hour fed Leptin dose 0.01 mg/kg

  16. Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.1 mg/kg [ Time Frame: 1 DAY ]
    24-hour fed Leptin dose 0.1 mg/kg

  17. Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.1 mg/kg [ Time Frame: 1 DAY ]
    24-hour fed Leptin dose 0.1 mg/kg

  18. Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.1 mg/kg [ Time Frame: 1 DAY ]
    24-hour fed Leptin dose 0.1 mg/kg


Secondary Outcome Measures :
  1. Cytokine Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg) [ Time Frame: 1 DAY or DAY 3 ]
    Data were collected neither in Fed nor in Fasting state for the different doses of leptin

  2. Neuroendocrine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg) [ Time Frame: 1 DAY or DAY 3 ]
    Data were collected neither in Fed nor in Fasting state for the different doses of leptin

  3. Adipokine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg) [ Time Frame: day 3 of fasting and day 1 of fed state ]
    Data were collected neither in Fed nor in Fasting state for the different doses of leptin



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy men with body mass indices (BMI) <25 kg/m2)
  • overweight otherwise healthy men with BMI > 27 kg/m2
  • healthy lean women with BMI<25 kg/m2
  • overweight otherwise healthy women with BMI > 27 kg/m2

Exclusion Criteria:

  • history of any illness that may affect the concentrations of the hormones that will be studied (such as anemia, infectious diseases, renal or hepatic failure, diabetes mellitus, cancer, lymphoma, hypogonadism, malabsorption or malnourishment, hypo or hyperthyroidism, hypercortisolism, alcoholism or drug abuse, eating disorders)
  • on medications known to affect the hormones to be measured in this study (such as glucocorticoids, anti-seizure medications or thyroid hormones)
  • known history of anaphylaxis or anaphylactoid-like reactions or who have a known hypersensitivity to E. Coli derived proteins
  • women who are breast feeding, pregnant, or wanting to become pregnant during the next 6 months

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): NCT00140205


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Amgen
Investigators
Principal Investigator: Christos S Mantzoros, MD DSc FACP FACE Beth Israel Deaconess Medical Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christos Mantzoros, Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00140205     History of Changes
Other Study ID Numbers: 2001P000260
First Posted: September 1, 2005    Key Record Dates
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018
Last Verified: May 2017

Keywords provided by Christos Mantzoros, Beth Israel Deaconess Medical Center:
leptin
fasting
pharmacokinetics