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Evaluation of Liposomal Curcumin in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01403545
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : May 26, 2014
Sponsor:
Information provided by (Responsible Party):
Michael Wolzt, M.D., Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE July 26, 2011
First Posted Date  ICMJE July 27, 2011
Last Update Posted Date May 26, 2014
Study Start Date  ICMJE August 2011
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2011)
Safety and tolerability of increasing doses of intravenous liposomal Curcumin in healthy subjects by means of adverse events, vital signs and safety laboratory assessments. [ Time Frame: From Baseline until 7 days after the study day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01403545 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2011)
Investigation of the pharmacokinetics of increasing doses of intravenous liposomal Curcumin in healthy subjects. [ Time Frame: From Baseline until 48 hours after IMP administration ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Liposomal Curcumin in Healthy Volunteers
Official Title  ICMJE Safety, Tolerability and Pharmacokinetics of Liposomal Curcumin in Healthy Volunteers - A Phase I Dose Escalation Study
Brief Summary

Aim of the present study is:

  • To evaluate the safety and tolerability of increasing doses of intravenous liposomal Curcumin in healthy subjects by means of adverse events, vital signs and safety laboratory assessments.
  • To investigate the pharmacokinetics of increasing doses of intravenous liposomal Curcumin in healthy subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Drug Safety
Intervention  ICMJE
  • Drug: Liposomal Curcumin
    Single dose intravenous infusion of liposomal Curcumin at 10, 20, 40, 80, 120, 180 mg/m² over 120 minutes
  • Other: Placebo
    5% glucose infusion over 120 minutes
Study Arms  ICMJE
  • Experimental: Liposomal Curcumin
    Single dose, dose escalation
    Intervention: Drug: Liposomal Curcumin
  • Placebo Comparator: 5% Glucose
    Intervention: Other: Placebo
Publications * Storka A, Vcelar B, Klickovic U, Gouya G, Weisshaar S, Aschauer S, Bolger G, Helson L, Wolzt M. Safety, tolerability and pharmacokinetics of liposomal curcumin in healthy humans. Int J Clin Pharmacol Ther. 2015 Jan;53(1):54-65. doi: 10.5414/CP202076.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 23, 2014)
50
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2011)
30
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and female subjects.
  • Age between 18-45 years.
  • Body mass index between 18-27 kg/m2
  • Vital signs within the normal range after 5 minutes in supine position (SBP: ≥90 mmHg and ≤140 mmHg, DBP: ≥45 mmHg and ≤90 mmHg, Heart rate: ≥45 bpm and ≤90 bpm).
  • Normal ECG (PR-interval ≤ 210 ms, QRS duration ≤ 140 ms, QTc ≤ 450 ms).
  • Adequate bone marrow function as evidenced by an absolute neutrophil count ≥1500 cells/µl, all normal red blood cell indices, hemoglobin greater than 11 g/dl and a platelet count greater than 150,000/µl.
  • Normal renal function.
  • Normal hepatic function as evidenced by serum total bilirubin ≤1.2 mg/dl, or less than or equal to the upper limit of normal, and alkaline phosphatase less than or equal to the upper limits of normal, and ASAT and ALAT less than or equal to the upper limits of normal.
  • Normal coagulation profile, and activated partial thromboplastin time (aPTT).
  • Normal urine analysis.
  • Signed informed consent.

Exclusion Criteria:

  • Intake of steroids within 2 weeks prior to the first dose of study drug.
  • Concomitant medications (especially anticoagulants and aspirin) or herbal supplements.
  • Active infection, or a fever > 38.5°C within three days prior to the first scheduled day of study drug dosing.
  • Current or past history evidence of disease (e.g. hemolytic diathesis, anemia requiring substitution therapy, hemochromatosis) that could be exacerbated by administration of liposomal curcumin.
  • History of prior malignancy within the past five years except for curatively treated non-melanoma skin cancer or cervical intraepithelial neoplasia.
  • Allergy requiring medical treatment within the last four weeks.
  • Known hypersensitivity to any of the components of turmeric.
  • Participation in another clinical trial within 4 weeks before study initiation.
  • NYHA Class 2 or congestive heart failure, uncontrolled hypertension, or arrhythmias.
  • Positive HIV serology or evidence of active hepatitis.
  • Unstable medical condition or any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with the patient's ability to sign the informed consent form, or his ability to cooperate and participate in the study, or to interfere with the interpretation of the results.
  • History of treated or active seizure disorder or any CNS or PNS neurological disorder.
  • Subjects who are pregnant or breast feeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01403545
Other Study ID Numbers  ICMJE Lipocurc1001
2011-001861-41 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Wolzt, M.D., Medical University of Vienna
Study Sponsor  ICMJE SignPath Pharma, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Wolzt, MD Medical University of Vienna, Department of Clinical Pharmacology
PRS Account SignPath Pharma, Inc.
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP