Clinical trial NCT03807050: Safety and Pharmacokinetics of Phaffia Rhodozyma Astaxanthin
Official title: Safety and Pharmacokinetics of Astaxanthin-Rich Carotenoid Extract (AstaFerm™) Administered as a Single Oral Dose to Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Absorption; Chemicals
Keywords: Pharmacokinetics
Lead sponsor: NextFerm Technologies LTD
Sponsor class: INDUSTRY
First posted: 2019-01-16
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

1. Healthy male volunteers between 18 and \<46 years of age.
2. Subjects who provide written informed consent to participate in the study.
3. BMI ranging from 18.0 to \<30.0, calculated as Weight (Kg)/Height (m2).
4. Non-smoking (by declaration) for a period of at least 6 months.
5. 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.
6. No history of drug or alcohol abuse.
7. No known allergy or hypersensitivity to any drug or food.
8. No clinically significant abnormalities in screening physical exam.
9. No clinically significant abnormalities in clinical laboratory parameters (hematology, biochemistry and urinalysis) at Screening, as determined by the study physicians.
10. Negative HIV antibody, Hepatitis B surface antigen and Hepatitis C antibody tests at Screening.
11. No significant abnormalities in electrocardiogram.at Screening.
12. Subjects with negative urinary drugs of abuse screen determined at Screening and on admission to the clinical research center prior to dosing day.
13. Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
14. Subjects must satisfy a medical examiner about their fitness to participate in the study.

Exclusion Criteria:

1. Subjects with any clinically significant abnormality upon physical examination or in the clinical laboratory test values.
2. 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.
3. Subjects with significant allergic response to any drug or history of food allergies deemed clinically significant or exclusionary for the study.
4. 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.
5. 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.
6. Use of paracetamol (acetaminophen) less than 24 hours before the first dosing day.
7. Subjects who donated blood or received blood or plasma derivatives in the three months preceding the first study dosing.
8. 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).
9. 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).
10. Subjects that have difficulty fasting or consuming the standard meals that will be provided.
11. 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.
12. Subjects who are non-cooperative or unwilling to sign the consent form.

Primary outcomes:
measure: Cmax
timeFrame: Estimated to be at 8 to 10 hours after dosing
measure: AUC 0-t
timeFrame: 168 hours after dosing
measure: Time max
timeFrame: Estimated to be at 8 to 10 hours after dosing
Secondary outcomes:
measure: Adverse Events (AEs)
timeFrame: 15 days
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
affiliation: Tel Aviv Sourasky Medical Center Israel
name: Oren Shibolet, Prof.
role: PRINCIPAL_INVESTIGATOR
References: