Absorption; ChemicalsNCT03807050
Safety and Pharmacokinetics of Phaffia Rhodozyma Astaxanthin
A study testing Astaxanthin in people with Absorption; Chemicals, run by NextFerm Technologies LTD at 1 site in Israel.
Trial summary
Astaxanthin is a xanthophyll carotenoid, a naturally occurring lipid-soluble red pigment. Apart from its coloring ability it is also a strong antioxidative ingredient and contains health-promoting properties. Read more about this study
- Who is it for?
- Ages 18 to 46 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Absorption; Chemicals
- What is being tested?
- Astaxanthin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- 19 Nov 2018to 1 Feb 2019
- Phase
- Interventional
- 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 46 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers between 18 and <46 years of age.
- Subjects who provide written informed consent to participate in the study.
- BMI ranging from 18.0 to <30.0, calculated as Weight (Kg)/Height (m2).
- Non-smoking (by declaration) for a period of at least 6 months.
- No known history of significant neurological, renal, cardiovascular (including known structural cardiac abnormalities or hypertension), respiratory (asthma), endocrine, gastrointestinal, hepatic or hematopoietic disease, neoplasm, psychiatric or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medications.
- No history of drug or alcohol abuse.
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- No known allergy or hypersensitivity to any drug or food.
- No clinically significant abnormalities in screening physical exam.
- No clinically significant abnormalities in clinical laboratory parameters (hematology, biochemistry and urinalysis) at Screening, as determined by the study physicians.
- Negative HIV antibody, Hepatitis B surface antigen and Hepatitis C antibody tests at Screening.
- No significant abnormalities in electrocardiogram.at Screening.
- Subjects with negative urinary drugs of abuse screen determined at Screening and on admission to the clinical research center prior to dosing day.
- Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- Subjects must satisfy a medical examiner about their fitness to participate in the study.
Who cannot join
- Subjects with any clinically significant abnormality upon physical examination or in the clinical laboratory test values.
- Subjects with a history of clinically defined peptic ulcer or any gastrointestinal surgery other than appendectomy or herniotomy, or with any gastrointestinal disorder likely to influence supplement absorption, or with any history of severe gastrointestinal narrowing, or frequent nausea or emesis, regardless of etiology.
- Subjects with significant allergic response to any drug or history of food allergies deemed clinically significant or exclusionary for the study.
- Adherence (for whatever reason) to an abnormal diet during the 4 weeks prior to the study, or subjects with recent significant change in body weight.
- Treatment with prescription or over-the-counter drugs, nutraceuticals including vitamins, herbal medications, food supplements and other prescription drugs not mentioned above, within 7 days prior to first dosing day.
- Use of paracetamol (acetaminophen) less than 24 hours before the first dosing day.
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- Subjects who donated blood or received blood or plasma derivatives in the three months preceding the first study dosing.
- Participation in another clinical trial with drugs within 3 months prior to first study dosing day (calculated from the previous study's last dosing date).
- Subjects with an inability to communicate well with the investigators and Clinical research Center staff (i.e., language problem, poor mental development or impaired cerebral function).
- Subjects that have difficulty fasting or consuming the standard meals that will be provided.
- Subjects with any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the Principal Investigator.
- Subjects who are non-cooperative or unwilling to sign the consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Pharmacokinetics of Astaxanthin-Rich Carotenoid Extract (AstaFerm™) Administered as a Single Oral Dose to Healthy Adults
Astaxanthin is a xanthophyll carotenoid, a naturally occurring lipid-soluble red pigment. Apart from its coloring ability it is also a strong antioxidative ingredient and contains health-promoting properties.
Study aim is to monitor the safety and tolerability of AstaFerm™, an astaxanthin dietary supplement derived from the yeast Phaffia rhodozyma. Pharmacokinetics profile is tested in 12 healthy male adults who received a single dose of AstaFerm™ in a single-center, open-label, non-randomized, single-dose study. Subjects are admitted to the clinical research center on the evening before dosing. On the next morning, after overnight fast, pre-dosing plasma sampling is performed, then they receive a fat balanced breakfast followed by a single administration of AstaFerm™ capsules. The capsules contain 50 milligram astaxanthin derived from Phaffia rhodozyma. Following dosing, blood sampling is performed for 24 hours in-house (2, 4, 6, 8, 10, 12 and 24-hours post-dose) and ambulatory at 48, 72- and 168-hours post-dose. Blood for antioxidant activity assessment is also drawn.
- Conditions
- Absorption; Chemicals
- Being tested
- Astaxanthin
- Keywords
- Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AstaxanthinDietary supplement
Also called AstaFerm
Capsules containing astaxanthin derived from the yeast Phaffia rhodozyma .
| Study group | Role | What they receive |
|---|---|---|
| Astaxanthin | Experimental | Astaxanthin capsules containing 50 milligram astaxanthin derived from the yeast Phaffia rhodozyma (Xanthophyllomyces dendrorhous) Receives: Dietary Supplement: Astaxanthin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
The maximum plasma concentration obtained in average of 12 subjects
Measured: Estimated to be at 8 to 10 hours after dosing
AUC 0-t
Calculate Area under the plasma concentration versus time curve from time =0 h to time of the last measurable concentration of 12 subjects
Measured: 168 hours after dosing
Time max
Time at which Cmax occurs
Measured: Estimated to be at 8 to 10 hours after dosing
Secondary outcomes (1)
Adverse Events (AEs)
Number of subjects that reported incidence of adverse events and details of adverse events that were reported
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start19 Nov 2018
- Primary completion23 Dec 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Absorption; ChemicalsStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- NextFerm Technologies LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oren Shibolet, Prof., Principal investigator, Tel Aviv Sourasky Medical Center Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807050
- Sponsor's protocol ID
- AstaFerm 001
- Status last verified
- Jan 2019
- First submitted
- 9 Jan 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetics of Astaxanthin-Rich Carotenoid Extract (AstaFerm™) Administered as a Single Oral Dose to Healthy Adults
- ClinicalTrials.gov ID
- NCT03807050
- Acronym / sponsor ID
- AstaFerm 001
- Conditions
- Absorption; Chemicals
- Keywords
- Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- NextFerm Technologies LTDIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 23 Dec 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 16 Jan 2019 (actual)
- 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.
Astaxanthin is a xanthophyll carotenoid, a naturally occurring lipid-soluble red pigment. Apart from its coloring ability it is also a strong antioxidative ingredient and contains health-promoting properties.
Study aim is to monitor the safety and tolerability of AstaFerm™, an astaxanthin dietary supplement derived from the yeast Phaffia rhodozyma. Pharmacokinetics profile is tested in 12 healthy male adults who received a single dose of AstaFerm™ in a single-center, open-label, non-randomized, single-dose study. Subjects are admitted to the clinical research center on the evening before dosing. On the next morning, after overnight fast, pre-dosing plasma sampling is performed, then they receive a fat balanced breakfast followed by a single administration of AstaFerm™ capsules. The capsules contain 50 milligram astaxanthin derived from Phaffia rhodozyma. Following dosing, blood sampling is performed for 24 hours in-house (2, 4, 6, 8, 10, 12 and 24-hours post-dose) and ambulatory at 48, 72- and 168-hours post-dose. Blood for antioxidant activity assessment is also drawn.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Astaxanthin | Experimental | Dietary Supplement: AstaxanthinAstaxanthin capsules containing 50 milligram astaxanthin derived from the yeast Phaffia rhodozyma (Xanthophyllomyces dendrorhous) |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy male volunteers between 18 and <46 years of age.
- Subjects who provide written informed consent to participate in the study.
- BMI ranging from 18.0 to <30.0, calculated as Weight (Kg)/Height (m2).
- Non-smoking (by declaration) for a period of at least 6 months.
- No known history of significant neurological, renal, cardiovascular (including known structural cardiac abnormalities or hypertension), respiratory (asthma), endocrine, gastrointestinal, hepatic or hematopoietic disease, neoplasm, psychiatric or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medications.
Key exclusion criteria (12 listed)
- Subjects with any clinically significant abnormality upon physical examination or in the clinical laboratory test values.
- Subjects with a history of clinically defined peptic ulcer or any gastrointestinal surgery other than appendectomy or herniotomy, or with any gastrointestinal disorder likely to influence supplement absorption, or with any history of severe gastrointestinal narrowing, or frequent nausea or emesis, regardless of etiology.
- Subjects with significant allergic response to any drug or history of food allergies deemed clinically significant or exclusionary for the study.
- Adherence (for whatever reason) to an abnormal diet during the 4 weeks prior to the study, or subjects with recent significant change in body weight.
- Treatment with prescription or over-the-counter drugs, nutraceuticals including vitamins, herbal medications, food supplements and other prescription drugs not mentioned above, within 7 days prior to first dosing day.
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 |
|---|---|---|
| AstaxanthinAlso: AstaFermCapsules containing astaxanthin derived from the yeast Phaffia rhodozyma . | Dietary supplement | Astaxanthin |
Primary outcome
Cmax
Time frame: Estimated to be at 8 to 10 hours after dosing
The maximum plasma concentration obtained in average of 12 subjects
AUC 0-t
Time frame: 168 hours after dosing
Calculate Area under the plasma concentration versus time curve from time =0 h to time of the last measurable concentration of 12 subjects
Time max
Time frame: Estimated to be at 8 to 10 hours after dosing
Time at which Cmax occurs
1 secondary outcome
Adverse Events (AEs)
Time frame: 15 days
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 21 Mar 2019.
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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.
Oren Shibolet, Prof. principal investigator
Tel Aviv Sourasky Medical Center Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Astaxanthin in people with Absorption; Chemicals, run by NextFerm Technologies LTD at 1 site in Israel.
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 14 inclusion and 12 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 21 Mar 2019. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Cmax (time frame: Estimated to be at 8 to 10 hours after dosing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2019.