Status:
COMPLETED
Phase I Study of PH100 (Ecklonia Cava Phlorotannins)
Lead Sponsor:
Phloronol Inc.
Collaborating Sponsors:
Worldwide Clinical Trials
Conditions:
Safety Issues
Eligibility:
All Genders
40-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study was to determine the safety and tolerability of PH100, a purified phlorotannins from a brown alga Ecklonia cava and the pharmacokinetics of its major compounds 8,8'-bieckol, ...
Detailed Description
This was a single-center, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers in which subjects received either placebo or a 100 mg, 200 mg, 400 mg, 800 mg,...
Eligibility Criteria
Inclusion
- Male or nonpregnant, nonbreastfeeding female;
- Between 40 and 75 years of age (inclusive);
- Body mass index (BMI) between 18 and 30 kg/m2 (inclusive), and minimum weight of 50 kg (110 lbs);
- If female, subject was considered postmenopausal or surgically sterile and had status confirmed by one of the following:
- Physiologicallypostmenopausalbasedonnomensesforatleast2years(not due to lactational amenorrhea) and follicle stimulating hormone (FSH) levels equal to or greater than 40.0 mIU/mL at screening; or
- Bilateraloophorectomy,hysterectomy,orbilateraltuballigation(post 6 months). Or
- If female and of childbearing potential, subject agreed to use one of the following forms of birth control from 3 months prior through 12 days after study drug administration:
- Vasectomizedpartner(atleast6monthspriortodosing);
- Doublebarrier(diaphragmwithspermicide;condomswithspermicide);
- Intrauterinedevice(IUD);
- Abstinence(agreedtouseadoublebarriermethodiftheybecamesexually active during the study);
- Implantedorintrauterinehormonalcontraceptives;or
- Oral,patch,orinjectedcontraceptives,orvaginalhormonaldevice (i.e. NuvaRing®).
- If male, subject had a documented vasectomy or agreed to use a double-barrier local contraception (i.e., condom with spermicide) when engaging in sexual activity with women of childbearing potential from prior to the first dose of study drug through 28 days after the last dose of study drug;
- If male, subject agreed to refrain from sperm donation from prior to the first dose of study drug through 28 days after the last dose of study drug;
- Voluntarily consented to participate in this study and provided their written informed consent prior to start of any study-specific procedures;
- Able to communicate with the Investigator, and understand and comply with the requirements of the protocol;
- Willing and able to remain in the study unit for the entire duration of the confinement period and return for an outpatient visit;
- Had screening blood pressure (measured sitting after 3 minutes rest) 140/90 mmHg. Out-of-range blood pressure could be repeated once; and
- Willing and able to swallow up to eight size AAA capsules with water at dose administration. Size AAA capsules are 0.642 inches (16.31 mm) in length and 0.450 inches (11.44 mm) in diameter).
Exclusion
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, GI, endocrine (including thyroid), immunologic, dermatologic, neurologic, oncologic, respiratory, lymphatic, musculoskeletal, genitourinary, infective, inflammatory, connective tissue, or psychiatric disease or disorder or any other condition that, in the opinion of the Investigator, would have jeopardized the safety of the subject or the validity of the study results;
- Clinically relevant history or presence of cardiac arrhythmia, narrow angle glaucoma, benign prostatic hypertrophy (men only), Hashimoto's thyroiditis, lymphocytic thyroiditis, or uncontrolled diabetes;
- Had a clinically significant abnormal finding on the physical exam, medical history, ECG, or clinical laboratory results at screening;
- History or presence of allergic or adverse response to PH100 (product names: Seapolynol, Fibroboost, Fibronol, Seanol Longevity Plus, Circulate, Alginol, PC Ecklonia Cava, Seanol, Seanol-F, Seanol-EX, Seanol-TX, Venusen, Memories with Seanol-P, Astaxanthol, Brilliant Vision with Seanol-P, Gly-Control, Gyne-Andro-Plex, Lipid Balance, Seanol with Broccoraphanin, and Marine D3) or related drugs;
- Had used PH100 (product names: Seapolynol, Fibroboost, Fibronol, Seanol Longevity Plus, Circulate, Alginol, PC Ecklonia Cava, Seanol, Seanol-F, Seanol-EX, Seanol-TX, Venusen, Memories with Seanol-P, Astaxanthol, Brilliant Vision with Seanol-P, Gly-Control, Gyne-Andro-Plex, Lipid Balance, Seanol with Broccoraphanin, and Marine D3) as a supplement within 30 days prior to the first dose of study medication;
- Had been on a significantly abnormal diet during the 4 weeks preceding the first dose of study medication;
- Had donated blood or plasma within 30 days prior to the first dose of study medication;
- Had participated in another clinical trial (randomized subjects only) within 30 days prior to first dose of study medication;
- Had used any over-the-counter (OTC) medication, including nutritional supplements, within 5 half-lives or 14 days (whichever was longer) prior to the first dose of study medication;
- Had used any prescription medication, except hormonal contraceptives for women of childbearing potential or hormone replacement therapy, within 5 half-lives or 14 days (whichever was longer) prior to the first dose of study medication;
- Had ingested drinks or foods containing grapefruit or St. John's Wort within 14 days prior to the first dose of study medication;
- Had been treated with any known drugs that are moderate or strong inhibitors/inducers of CYP enzymes such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication and that in the Investigator's judgment may have impacted subject safety or the validity of the study results;
- Had discontinued the use of implanted, intrauterine, or injected hormonal contraceptives less than 6 months prior to the first dose of study medication;
- Had discontinued the use of oral, patch, or vaginal hormonal contraceptives less than 1 month prior to the first dose of study medication;
- Had smoked or used tobacco products within 6 months prior to the first dose of study medication;
- Had a history of substance abuse or treatment (including alcohol);
- Was a female who had a positive pregnancy test result or was nursing, lactating, or trying to become pregnant;
- Had a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates), alcohol, or cotinine;
- Had a positive test for hepatitis B surface antigen (HbSAg), hepatitis C antibody, or human immunodeficiency virus (HIV) at screening or had been previously treated for hepatitis B, hepatitis C, or HIV infection; or
- Had difficulty swallowing up to eight capsules.
Key Trial Info
Start Date :
September 25 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2014
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04335045
Start Date
September 25 2013
End Date
December 8 2014
Last Update
April 6 2020
Active Locations (1)
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1
Worldwide Clinical Trials Early Phase Services, LLC
San Antonio, Texas, United States, 78217