Drug SafetyPhase 1NCT01403545
Evaluation of Liposomal Curcumin in Healthy Volunteers
A Phase 1 study testing Liposomal Curcumin in people with Drug Safety, run by SignPath Pharma, Inc. at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Safety
- What is being tested?
- Liposomal Curcumin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2011to Aug 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, State of Vienna, 1090
About this study
Official title: 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.
- Conditions
- Drug Safety
- Being tested
- Liposomal Curcumin, Placebo
- Keywords
- Safety, Tolerability, Pharmacokinetics, Liposomal Curcumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal CurcuminDrug
Single dose intravenous infusion of liposomal Curcumin at 10, 20, 40, 80, 120, 180 mg/m² over 120 minutes
PlaceboOther
5% glucose infusion over 120 minutes
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Curcumin | Experimental | Single dose, dose escalation Receives: Drug: Liposomal Curcumin |
| 5% Glucose | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of increasing doses of intravenous liposomal Curcumin in healthy subjects by means of adverse events, vital signs and safety laboratory assessments.
Measured: From Baseline until 7 days after the study day
Secondary outcomes (1)
Investigation of the pharmacokinetics of increasing doses of intravenous liposomal Curcumin in healthy subjects.
Measured: From Baseline until 48 hours after IMP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- SignPath Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Michael Wolzt, M.D., Medical University of Vienna
- Investigators
- Michael Wolzt, MD, Principal investigator, Medical University of Vienna, Department of Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403545
- Sponsor's protocol ID
- Lipocurc1001
- Other IDs
- 2011-001861-41
- Status last verified
- May 2014
- First submitted
- 26 Jul 2011
- Last updated
- 26 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 25500488
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics of Liposomal Curcumin in Healthy Volunteers - A Phase I Dose Escalation Study
- ClinicalTrials.gov ID
- NCT01403545
- Acronym / sponsor ID
- Lipocurc1001
- Conditions
- Drug Safety
- Keywords
- Safety, Tolerability, Pharmacokinetics, Liposomal Curcumin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- SignPath Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 27 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Curcumin | Experimental | Drug: Liposomal CurcuminSingle dose, dose escalation |
| 5% Glucose | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal CurcuminSingle dose intravenous infusion of liposomal Curcumin at 10, 20, 40, 80, 120, 180 mg/m² over 120 minutes | Drug | Liposomal Curcumin |
| Placebo5% glucose infusion over 120 minutes | Other | 5% Glucose |
Primary outcome
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
1 secondary outcome
Investigation of the pharmacokinetics of increasing doses of intravenous liposomal Curcumin in healthy subjects.
Time frame: From Baseline until 48 hours after IMP administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
- Derived from this study: PubMed 25500488Storka 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Wolzt, MD principal investigator
Medical University of Vienna, Department of Clinical Pharmacology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Liposomal Curcumin in people with Drug Safety, run by SignPath Pharma, Inc. at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: From Baseline until 7 days after the study day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01403545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2014.