Clinical trial NCT01403545: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Safety
Keywords: Safety
Tolerability
Pharmacokinetics
Liposomal Curcumin
Lead sponsor: SignPath Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Safety and tolerability of increasing doses of intravenous liposomal Curcumin in healthy subjects by means of adverse events, vital signs and safety laboratory assessments.
timeFrame: From Baseline until 7 days after the study day
Secondary outcomes:
measure: Investigation of the pharmacokinetics of increasing doses of intravenous liposomal Curcumin in healthy subjects.
timeFrame: From Baseline until 48 hours after IMP administration
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Clinical Pharmacology
Study officials:
affiliation: Medical University of Vienna, Department of Clinical Pharmacology
name: Michael Wolzt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.