- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05296083
A Safety/Tolerance Phase, Ascending Single Dose Study to Evaluate the Safety and Tolerability of G3P-01, a Food-Grade Pectic Product, in Healthy Volunteers (G3P-01-01)
June 8, 2022 updated by: SQ Innovation, Inc.
This is an interventional, open-label study to evaluate the safety, tolerability and PK of escalating single doses of G3P-01 in 10 healthy adult subjects.
All participants will receive G3P-01 in sequential, escalating doses of 50mg (Period 1), 500mg (Period 2), 1,000mg (Period 3), and 2,000mg (Period 4).
A wash out period of at least 7 days will occur between doses in each sequential treatment period.
Subjects will be admitted Day 1 and stay overnight until the morning of Day 2 for each treatment period.
There will be a follow up call 14 days (+/- 2 days) following the last dose of the IP.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Flevoland
-
Almere, Flevoland, Netherlands, 1311 RL
- EB FlevoResearch
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female, aged ≥ 18 to < 65 years;
- Healthy volunteers, as determined by a comprehensive clinical assessment performed at screening (medical history, vital signs, clinical laboratory testing, ECG, and general physical examination);
- Maintains a regular (mixed or vegetarian/vegan) diet.
Non-pregnant, non-lactating females who are either post-menopausal (natural or surgical) or are using at least one (1) of the following forms of contraception:
- Intrauterine device (IUD),
- Implantable progestogen-only hormone contraception associated with inhibition of ovulation,
- Intrauterine hormone-releasing system (IUS),
- Bilateral tubal occlusion
- Vasectomized partner
- Male or female condom with or without spermicide,
- Cervical cap, diaphragm, or sponge with spermicide,
- A combination of male condoms with either cervical cap, diaphragm, or sponge with spermicide (double-barrier methods)
Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation
- oral
- intravaginal
- transdermal
- injectable
Progestogen-only hormone contraception associated with inhibition of ovulation
- oral
- injectable
- Abstinence;
- Willing to adhere to the prohibitions and restrictions specified in the protocol;
- Must be competent to understand the nature of the study and capable of giving written informed consent and be willing to report for the scheduled study visits and communicate to study personnel about adverse events and concomitant medication use.
Exclusion Criteria:
- History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator;
- Clinically significant abnormal laboratory test values at screening, as determined by the Investigator;
- Any surgical or medical condition, which in the opinion of the Investigator may pose an undue risk to the subject, interfere with participation in the study, or which may affect the integrity of the study data.
- Any positive urine drug screen or alcohol test at Screening or clinic admission.
- Concomitant use of any drugs known to interact with oral absorption or metabolism of pharmaceuticals, including known inducers or inhibitors of cytochrome p450 enzyme system.
- History of alcohol abuse within 6 months prior to Screening and/or signs or symptoms of alcoholism, as determined by the Investigator.
- Positive test for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV);
- Participation in another clinical trial of an investigational drug (or medical device), or food supplement within 30 days prior to screening, or currently participating in another trial of an investigational drug (or medical device), or food supplement;
- Donation of greater than 100 mL of either whole blood or plasma within 30 days prior to investigational product administration.
- Been informed of possible COVID-19 exposure in past 4 weeks, or recent onset of signs or symptoms of possible COVID-19 infection, including cough, shortness of breath, or temperature ≥ 38°C.
- Traveled via airplane or cruise ship within the last 14 days
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: G3P-01 50mg Dose Treatment Period 1
G3P-01 will be administered orally as a powdered mixed with water.
Treatment Period one dose will be 50mg of IP.
|
G3P-01 is a food-grade pectic product derived from squash.
|
Experimental: G3P-01 500mg Dose Treatment Period 2
G3P-01 will be administered orally as a powdered mixed with water.
Treatment Period two dose will be 500mg of IP.
|
G3P-01 is a food-grade pectic product derived from squash.
|
Experimental: G3P-01 1000mg Dose Treatment Period 3
G3P-01 will be administered orally as a powdered mixed with water.
Treatment Period three dose will be 1000mg of IP.
|
G3P-01 is a food-grade pectic product derived from squash.
|
Experimental: G3P-01 2000mg Dose Treatment Period 4
G3P-01 will be administered orally as a powdered mixed with water.
Treatment Period four dose will be 2000mg of IP.
|
G3P-01 is a food-grade pectic product derived from squash.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number, severity, and nature of adverse events following the administration of ascending doses of G3-P01
Time Frame: Through study completion, up to 70 days
|
Evaluating the safety of ascending doses of G3-P01 based on treatment related adverse events
|
Through study completion, up to 70 days
|
Clinical safety and laboratory parameters- Adverse Events
Time Frame: Through study completion, up to 70 days
|
Number of participants with treatment emergent adverse events.
Measured by observation and reporting
|
Through study completion, up to 70 days
|
Clinical safety and laboratory parameters-Clinical Laboratory Results,hematology
Time Frame: Through study completion, up to 70 days
|
Number of participants with clinically significant change in clinical laboratory results reported as AEs.
Measured by Hematology/Serum Chemistry.
|
Through study completion, up to 70 days
|
Clinical safety and laboratory parameters-Clinical Laboratory Results, urinalysis
Time Frame: Through study completion, up to 70 days
|
Number of participants with clinically significant change in clinical laboratory results reported as AEs.
Measured by Urinalysis.
|
Through study completion, up to 70 days
|
Clinical safety and laboratory parameters-Clinical Laboratory Results, serology
Time Frame: Through study completion, up to 70 days
|
Number of participants with clinically significant change in clinical laboratory results reported as AEs.
Measured by Serology,
|
Through study completion, up to 70 days
|
Clinical safety and laboratory parameters-Vital Signs, blood pressure
Time Frame: Through study completion, up to 70 days
|
Number of participants with clinically significant change in vital signs reported as AEs.
Measured by BP
|
Through study completion, up to 70 days
|
Clinical safety and laboratory parameters-Vital Signs, pulse
Time Frame: Through study completion, up to 70 days
|
Number of participants with clinically significant change in vital signs reported as AEs.
Measured by pulse.
|
Through study completion, up to 70 days
|
Clinical safety and laboratory parameters-Vital Signs, respiratory rate.
Time Frame: Through study completion, up to 70 days
|
Number of participants with clinically significant change in vital signs reported as AEs.
Measured by respiratory rate.
|
Through study completion, up to 70 days
|
Clinical safety and laboratory parameters-Vital Signs, body temperature.
Time Frame: Through study completion, up to 70 days
|
Number of participants with clinically significant change in vital signs reported as AEs.
Measured by body temperature.
|
Through study completion, up to 70 days
|
Change from baseline in tolerability assessment using Questionnaire
Time Frame: Through study completion, up to 70 days
|
Tolerability assessment using the Gastrointestinal Symptom Rating Scale (GSRS).
There are 15 individual questions, each with a score of 1-7.
Higher scores reflect a worse outcome.
|
Through study completion, up to 70 days
|
Change from baseline in performance status using Questionnaire
Time Frame: Through study completion, up to 70 days
|
Performance status assessment using the Karnofsky Performance Scale Index.
The scale is 0-100, with 0 reflecting a worse outcome.
|
Through study completion, up to 70 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic parameters- Cmax
Time Frame: Up to 3 years
|
Subject to the development of suitable analytical methods, maximum plasma concentration will be determined.
|
Up to 3 years
|
Pharmacokinetic parameters- Tmax
Time Frame: Up to 3 years
|
Subject to the development of suitable analytical methods, time corresponding to the Cmax will be determined.
|
Up to 3 years
|
Pharmacokinetic parameters- AUC
Time Frame: Up to 3 years
|
Subject to the development of suitable analytical methods, Area under the plasma concentration-time curve (AUC)" from time zero to the last non-zero concentration (AUC0-t), from time zero till 24-hours post-dose (AUC0-24), from time infinity (extrapolated) (AUC0-inf) will be determined.
|
Up to 3 years
|
Pharmacokinetic parameters- T1/2/ el
Time Frame: Up to 3 years
|
Subject to the development of suitable analytical methods, elimination half-life will be determined.
|
Up to 3 years
|
Pharmacokinetic parameters- Vd
Time Frame: Up to 3 years
|
Subject to the development of suitable analytical methods, volume distribution will be determined.
|
Up to 3 years
|
Pharmacokinetic parameters- Clr
Time Frame: Up to 3 years
|
Subject to the development of suitable analytical methods, renal clearance will be determined.
|
Up to 3 years
|
Pharmacokinetic parameters- dose proportionality
Time Frame: Up to 3 years
|
Subject to the development of suitable analytical methods, dose proportionality will be determined.
|
Up to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mazin AlHakim, MD, EB FlevoResearch
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 17, 2022
Primary Completion (Actual)
May 25, 2022
Study Completion (Actual)
May 25, 2022
Study Registration Dates
First Submitted
February 8, 2022
First Submitted That Met QC Criteria
March 15, 2022
First Posted (Actual)
March 25, 2022
Study Record Updates
Last Update Posted (Actual)
June 13, 2022
Last Update Submitted That Met QC Criteria
June 8, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- G3P-01-01
- NL80001.028.21 (Other Identifier: CCMO)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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