Evaluation of Liposomal Curcumin in Healthy Volunteers

Study Overview
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Brief Summary
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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.

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

Conditions
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Drug Safety

Intervention / Treatment
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* Drug: Liposomal Curcumin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Tolerability, Pharmacokinetics, Liposomal Curcumin