Evaluation of Liposomal Curcumin in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Wolzt, M.D., Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01403545
First received: July 26, 2011
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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.

Condition Intervention Phase
Drug Safety
Drug: Liposomal Curcumin
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Safety, Tolerability and Pharmacokinetics of Liposomal Curcumin in Healthy Volunteers - A Phase I Dose Escalation Study

Resource links provided by NLM:


Further study details as provided by SignPath Pharma, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Investigation of the pharmacokinetics of increasing doses of intravenous liposomal Curcumin in healthy subjects. [ Time Frame: From Baseline until 48 hours after IMP administration ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: August 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403545

Locations
Austria
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
SignPath Pharma, Inc.
Investigators
Principal Investigator: Michael Wolzt, MD Medical University of Vienna, Department of Clinical Pharmacology
  More Information

No publications provided

Responsible Party: Michael Wolzt, M.D., Ao. Univ. Prof. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01403545     History of Changes
Other Study ID Numbers: Lipocurc1001, 2011-001861-41
Study First Received: July 26, 2011
Last Updated: May 23, 2014
Health Authority: Austria: Agency for Health and Food Safety (AGES)

Keywords provided by SignPath Pharma, Inc.:
Safety
Tolerability
Pharmacokinetics
Liposomal Curcumin

Additional relevant MeSH terms:
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014