Evaluation of Liposomal Curcumin in Healthy Volunteers

Drug Safety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01403545
• Other study ID #: Lipocurc1001
• Secondary ID: 2011-001861-41
• Status: Completed
• Phase: Phase 1
• First received: July 26, 2011
• Last updated: May 23, 2014
• Start date: August 2011
• Est. completion date: August 2012

Study information

• Verified date: May 2014
• Source: SignPath Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety (AGES)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• 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

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of Clinical Pharmacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
SignPath Pharma, Inc.

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Investigation of the pharmacokinetics of increasing doses of intravenous liposomal Curcumin in healthy subjects.		From Baseline until 48 hours after IMP administration	No