AzTrials
AzTrials

Safety IssuesPhase 1NCT04335045

Phase I Study of PH100 (Ecklonia Cava Phlorotannins)

A Phase 1 study testing PH100 100mg, PH100 200mg and PH100 400mg in people with Safety Issues, run by Phloronol Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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, dieckol, and phlorofucofuroeckol A (PFF-A), after single, ascending, oral doses of PH100 Capsules (over-encapsulated… Read more about this study

Who is it for?
Ages 40 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Safety Issues
What is being tested?
PH100 100mg, PH100 200mg and PH100 400mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteUnited States
Study dates
25 Sep 2013to 8 Dec 2014
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 40 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 20Show fewer
  • 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).

Who cannot join

  • 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;
Show all 20Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Worldwide Clinical Trials Early Phase Services, LLC

    San Antonio, Texas, 78217

Other trials in United States

About this study

Official title: A Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PH100 Capsules in Healthy Adult Volunteers

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, dieckol, and phlorofucofuroeckol A (PFF-A), after single, ascending, oral doses of PH100 Capsules (over-encapsulated tablets) in healthy adult volunteers.

Read the 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, 1200 mg, or 1600 mg dose of PH100 capsules (over-encapsulated tablets containing purified Ecklonia cava phlorotannins as an active ingredient) in escalating dose groups (six cohorts). A total of 48 subjects were enrolled. Each cohort comprised eight subjects. Within each cohort, six subjects received PH100 and two subjects received placebo. The first cohort was dosed as a single group with PH100 (100 mg) or placebo. The subsequent five cohorts were dosed sequentially with 200 mg, 400 mg, 800 mg, 1200 mg, and 1600 mg of PH100 or placebo. Safety and pharmacokinetic data were collected and evaluated following each cohort. Dose escalation occurred after review of the safety and pharmacokinetic data from the preceding cohort(s). Doses were administered with subjects in the fasted condition.

Conditions
Safety Issues
Being tested
Placebo, PH100 100mg, PH100 200mg, PH100 400mg, PH100 800mg
Keywords
Safety, Tolerability, Pharmacokinetics, PH100, Ecklonia cava, Phlorotannin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    1~8 Placebo capsule(s) corresponding to each PH100 dose

  • PH100 100mgDrug

    1 x 100 mg PH100 oral capsule

  • PH100 200mgDrug

    1 x 200 mg PH100 oral capsule

  • PH100 400mgDrug

    2 x 200 mg PH100 oral capsules

  • PH100 800mgDrug

    4 x 200 mg PH100 oral capsules

  • PH100 1200mgDrug

    6 x 200 mg PH100 oral capsules

  • PH100 1600mgDrug

    8 x 200 mg PH100 oral capsules

Study groups in NCT04335045
Study groupRoleWhat they receive
100mg DoseActive comparator1 x 100 mg PH100 capsule (n=6)
Receives: Drug: PH100 100mg
Control for 100mg DosePlacebo comparator1 placebo capsule (n=2)
Receives: Drug: Placebo
200mg DoseActive comparator1 x 200 mg PH100 capsule (n=6)
Receives: Drug: PH100 200mg
Control for 200mg DosePlacebo comparator1 placebo capsule (n=2)
Receives: Drug: Placebo
400mg DoseActive comparator2 x 200 mg PH100 capsules (n=6)
Receives: Drug: PH100 400mg
Control for 400mg DosePlacebo comparator2 placebo capsules (n=2)
Receives: Drug: Placebo
800mg DoseActive comparator4 x 200 mg PH100 capsules (n=6)
Receives: Drug: PH100 800mg
Control for 800mg DosePlacebo comparator4 placebo capsules (n=2)
Receives: Drug: Placebo
1200mg DoseActive comparator6 x 200 mg PH100 capsules (n=6)
Receives: Drug: PH100 1200mg
Control for 1200mg DosePlacebo comparator6 placebo capsules (n=2)
Receives: Drug: Placebo
1600mg DoseActive comparator8 x 200 mg PH100 capsules (n=6)
Receives: Drug: PH100 1600mg
Control for 1600mg DosePlacebo comparator8 placebo capsules (n=2)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment emergent adverse events

    Subjects were instructed to inform the study physician and/or research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the beginning of confinement through the end-of-study visit (96 hours after dose administration). Reported or observed AEs were documented and followed to resolution.

    Measured: 96 hours postdose

  2. Hematocrit (%)

    Safety Assessment in Hematology

    Measured: 48 hours postdose

  3. Hemoglobin (g/dL)

    Safety Assessment in Hematology

    Measured: 48 hours postdose

  4. Erythrocytes (10^6/uL)

    Safety Assessment in Hematology

    Measured: 48 hours postdose

  5. Leukocytes (10^3/uL)

    Safety Assessment in Hematology

    Measured: 48 hours postdose

  6. Basophils (10^3/uL)

    Safety Assessment in Hematology

    Measured: 48 hours postdose

  7. Basophils/Leukocytes (%)

    Safety Assessment in Hematology

    Measured: 48 hours postdose

  8. Eosinophils (10^3/uL)

    Safety Assessment in Hematology

    Measured: 48 hours postdose

  9. Eosinophils/Leukocytes (%)

    Safety Assessment in Hematology

    Measured: 48 hours postdose

  10. Lymphocytes (10^3/uL)

    Safety Assessment in Hematology

    Measured: 48 hours postdose

  11. Lymphocytes/Leukocytes (%)

    Safety Assessment in Hematology

    Measured: 48 hours postdose

  12. Monocytes (10^3/uL)

    Safety Assessment in Hematology

    Measured: 48 hours postdose

  13. Monocytes/Leukocytes (%)

    Safety Assessment in Hematology

    Measured: 48 hours postdose

  14. Neutrophils (10^3/uL)

    Safety Assessment in Hematology

    Measured: 48 hours postdose

  15. Neutrophils/Leukocytes (%)

    Safety Assessment in Hematology

    Measured: 48 hours postdose

  16. Platelets (10^3/uL)

    Safety Assessment in Hematology

    Measured: 48 hours postdose

  17. Serum Glucose (mg/dL)

    Safety Assessment in Serum Chemistry

    Measured: 48 hours postdose

  18. Sodium (mmol/L)

    Safety Assessment in Serum Chemistry

    Measured: 48 hours postdose

  19. Potassium (mmol/L)

    Safety Assessment in Serum Chemistry

    Measured: 48 hours postdose

  20. Calcium (mg/dL)

    Safety Assessment in Serum Chemistry

    Measured: 48 hours postdose

  21. Chloride (mmol/L)

    Safety Assessment in Serum Chemistry

    Measured: 48 hours postdose

  22. Blood urea nitrogen (mg/dL)

    Safety Assessment in Serum Chemistry

    Measured: 48 hours postdose

  23. Creatinine (mg/dL)

    Safety Assessment in Serum Chemistry

    Measured: 48 hours postdose

  24. Urate (mg/dL)

    Safety Assessment in Serum Chemistry

    Measured: 48 hours postdose

  25. Albumin (g/dL)

    Safety Assessment in Serum Chemistry

    Measured: 48 hours postdose

  26. Alkaline phosphatase (U/L)

    Safety Assessment in Serum Chemistry

    Measured: 48 hours postdose

  27. Aspartate phosphatase (U/L)

    Safety Assessment in Serum Chemistry

    Measured: 48 hours postdose

  28. Alanine transaminase (U/L)

    Safety Assessment in Serum Chemistry

    Measured: 48 hours postdose

  29. Total bilirubin (mg/dL)

    Safety Assessment in Serum Chemistry

    Measured: 48 hours postdose

  30. Lactate Dehydrogenase (U/L)

    Safety Assessment in Serum Chemistry

    Measured: 48 hours postdose

  31. Specific gravity

    Safety Assessment in Urinalysis

    Measured: 48 hours postdose

  32. pH

    Safety Assessment in Urinalysis

    Measured: 48 hours postdose

  33. Glucose (mg/dL)

    Safety Assessment in Urinalysis

    Measured: 48 hours postdose

  34. Nitrite (Negative/Positive)

    Safety Assessment in Urinalysis

    Measured: 48 hours postdose

  35. Leukocyte esterase (/uL)

    Safety Assessment in Urinalysis

    Measured: 48 hours postdose

  36. Occult blood (/uL)

    Safety Assessment in Urinalysis

    Measured: 48 hours postdose

  37. Bilirubin (mg/dL)

    Safety Assessment in Urinalysis

    Measured: 48 hours postdose

  38. Urobilinogen (mg/dL)

    Safety Assessment in Urinalysis

    Measured: 48 hours postdose

  39. Change from Baseline Systolic Blood Pressure (mmHg)

    Safety Assessment in Vital Signs

    Measured: 2, 4, 48, 96 hours postdose

  40. Change from Baseline Diastolic Blood Pressure (mmHg)

    Safety Assessment in Vital Signs

    Measured: 2, 4, 48, 96 hours postdose

  41. Change from Baseline Pulse Rate (bpm)

    Safety Assessment in Vital Signs

    Measured: 2, 4, 48, 96 hours postdose

  42. Change from Baseline Respiration Rate (Breath/Min)

    Safety Assessment in Vital Signs

    Measured: 2, 4, 48, 96 hours postdose

  43. Change from Baseline Body Temperature (degrees C)

    Safety Assessment in Vital Signs

    Measured: 2, 4, 48, 96 hours postdose

  44. ECG heart rate (bpm)

    Safety Assessment in ECG

    Measured: 48 hours postdose

  45. PR interval (ms)

    Safety Assessment in ECG

    Measured: 48 hours postdose

  46. QRS complex (ms)

    Safety Assessment in ECG

    Measured: 48 hours postdose

  47. QT interval (ms)

    Safety Assessment in ECG

    Measured: 48 hours postdose

  48. QTcB interval (ms)

    Safety Assessment in ECG

    Measured: 48 hours postdose

  49. QTcF interval (ms)

    Safety Assessment in ECG

    Measured: 48 hours postdose

Secondary outcomes (3)

  1. Change in Blood Concentration of 8,8'-bieckol (ng/mL) by HPLC-MS

    Pharmacokinetics of 8,8'-bieckol, a major compound of PH100, after single, ascending, oral doses (100 mg, 200 mg, 400 mg, 800 mg, 1200 mg, and 1600 mg) of PH100 in normal healthy volunteers.

    Measured: at 0, 15, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 96 hours after dosing.

  2. Change in Blood Concentration of dieckol (ng/mL) by HPLC-MS

    Pharmacokinetics of 8,8'-bieckol, a major compound of PH100, after single, ascending, oral doses (100 mg, 200 mg, 400 mg, 800 mg, 1200 mg, and 1600 mg) of PH100 in normal healthy volunteers.

    Measured: at 0, 15, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 96 hours after dosing.

  3. Change in Blood Concentration of PFF-A (ng/mL) by HPLC-MS

    Pharmacokinetics of 8,8'-bieckol, a major compound of PH100, after single, ascending, oral doses (100 mg, 200 mg, 400 mg, 800 mg, 1200 mg, and 1600 mg) of PH100 in normal healthy volunteers.

    Measured: at 0, 15, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 96 hours after dosing.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2020
  2. Study start25 Sep 2013
  3. Primary completion8 Dec 2014
  4. Study completion8 Dec 2014

Resources

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
Sequential
Model description
Single-center, randomized, double-blind, placebo-controlled, single ascending dose study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04335045
Sponsor's protocol ID
13-01-01
Status last verified
Apr 2020
First submitted
31 Mar 2020
Last updated
6 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PH100 100mg, PH100 200mg and PH100 400mg in people with Safety Issues, run by Phloronol Inc. at 1 site in United States.

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 20 inclusion and 20 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 6 Apr 2020. 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 United States. 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?

Incidence of treatment emergent adverse events (time frame: 96 hours postdose). The study lists 49 primary outcomes in all. 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 NCT04335045.

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 6 Apr 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in