Evaluation of Liposomal Curcumin in Healthy Volunteers

• ClinicalTrials.gov Identifier: NCT01403545
• Recruitment Status: Completed
• First Posted: July 27, 2011
• Last Update Posted: May 26, 2014
• Sponsor: SignPath Pharma, Inc.
• Information provided by (Responsible Party): Michael Wolzt, M.D., Medical University of Vienna

Tracking Information

• First Submitted Date: July 26, 2011
• First Posted Date: July 27, 2011
• Last Update Posted Date: May 26, 2014
• Study Start Date: August 2011
• Actual Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT01403545 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of Liposomal Curcumin in Healthy Volunteers
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Drug Safety

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 23, 2014): 50
• Original Estimated Enrollment (submitted: July 26, 2011): 30
• Actual Study Completion Date: August 2012
• Actual Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria

Administrative Information

• NCT Number: NCT01403545
• Other Study ID Numbers: Lipocurc1001; 2011-001861-41 ( EudraCT Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Michael Wolzt, M.D., Medical University of Vienna
• Study Sponsor: SignPath Pharma, Inc.
• Collaborators: Not Provided

Investigators

• Principal Investigator: Michael Wolzt, MD; Medical University of Vienna, Department of Clinical Pharmacology

• PRS Account: SignPath Pharma, Inc.
• Verification Date: May 2014