Evaluation of Liposomal Curcumin in Healthy Volunteers

Safety, Tolerability and Pharmacokinetics of Liposomal Curcumin in Healthy Volunteers - A Phase I Dose Escalation Study

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.

Study Overview

• Status: Completed
• Conditions: Drug Safety
• Intervention / Treatment: Drug: Liposomal Curcumin; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna, Department of Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liposomal Curcumin; Single dose, dose escalation	Drug: Liposomal Curcumin; Single dose intravenous infusion of liposomal Curcumin at 10, 20, 40, 80, 120, 180 mg/m² over 120 minutes
Placebo Comparator: 5% Glucose	Other: Placebo; 5% glucose infusion over 120 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability of increasing doses of intravenous liposomal Curcumin in healthy subjects by means of adverse events, vital signs and safety laboratory assessments.	From Baseline until 7 days after the study day

Secondary Outcome Measures

Outcome Measure	Time Frame
Investigation of the pharmacokinetics of increasing doses of intravenous liposomal Curcumin in healthy subjects.	From Baseline until 48 hours after IMP administration

Collaborators and Investigators

• Sponsor: SignPath Pharma, Inc.
• Investigators: Principal Investigator: Michael Wolzt, MD, Medical University of Vienna, Department of Clinical Pharmacology

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: July 26, 2011
• First Submitted That Met QC Criteria: July 26, 2011
• First Posted (Estimate): July 27, 2011

Study Record Updates

• Last Update Posted (Estimate): May 26, 2014
• Last Update Submitted That Met QC Criteria: May 23, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Tolerability; Liposomal Curcumin
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: Lipocurc1001; 2011-001861-41 (EudraCT Number)