Gastrointestinal DiscomfortG3P-01-01NCT05296083
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
A study testing G3P-01 in people with Gastrointestinal Discomfort and Performance Status, run by SQ Innovation, Inc. at 1 site in Netherlands.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Discomfort, Performance Status
- What is being tested?
- G3P-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Mar 2022to 25 May 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Gastrointestinal Discomfort, Performance Status
- Being tested
- G3P-01
- Keywords
- Gastrointestinal, Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G3P-01Dietary supplement
G3P-01 is a food-grade pectic product derived from squash.
| Study group | Role | What they receive |
|---|---|---|
| G3P-01 50mg Dose Treatment Period 1 | Experimental | G3P-01 will be administered orally as a powdered mixed with water. Treatment Period one dose will be 50mg of IP. Receives: Dietary Supplement: G3P-01 |
| G3P-01 500mg Dose Treatment Period 2 | Experimental | G3P-01 will be administered orally as a powdered mixed with water. Treatment Period two dose will be 500mg of IP. Receives: Dietary Supplement: G3P-01 |
| G3P-01 1000mg Dose Treatment Period 3 | Experimental | G3P-01 will be administered orally as a powdered mixed with water. Treatment Period three dose will be 1000mg of IP. Receives: Dietary Supplement: G3P-01 |
| G3P-01 2000mg Dose Treatment Period 4 | Experimental | G3P-01 will be administered orally as a powdered mixed with water. Treatment Period four dose will be 2000mg of IP. Receives: Dietary Supplement: G3P-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number, severity, and nature of adverse events following the administration of ascending doses of G3-P01
Evaluating the safety of ascending doses of G3-P01 based on treatment related adverse events
Measured: Through study completion, up to 70 days
Clinical safety and laboratory parameters- Adverse Events
Number of participants with treatment emergent adverse events. Measured by observation and reporting
Measured: Through study completion, up to 70 days
Clinical safety and laboratory parameters-Clinical Laboratory Results,hematology
Number of participants with clinically significant change in clinical laboratory results reported as AEs. Measured by Hematology/Serum Chemistry.
Measured: Through study completion, up to 70 days
Clinical safety and laboratory parameters-Clinical Laboratory Results, urinalysis
Number of participants with clinically significant change in clinical laboratory results reported as AEs. Measured by Urinalysis.
Measured: Through study completion, up to 70 days
Clinical safety and laboratory parameters-Clinical Laboratory Results, serology
Number of participants with clinically significant change in clinical laboratory results reported as AEs. Measured by Serology,
Measured: Through study completion, up to 70 days
Clinical safety and laboratory parameters-Vital Signs, blood pressure
Number of participants with clinically significant change in vital signs reported as AEs. Measured by BP
Measured: Through study completion, up to 70 days
Clinical safety and laboratory parameters-Vital Signs, pulse
Number of participants with clinically significant change in vital signs reported as AEs. Measured by pulse.
Measured: Through study completion, up to 70 days
Clinical safety and laboratory parameters-Vital Signs, respiratory rate.
Number of participants with clinically significant change in vital signs reported as AEs. Measured by respiratory rate.
Measured: Through study completion, up to 70 days
Clinical safety and laboratory parameters-Vital Signs, body temperature.
Number of participants with clinically significant change in vital signs reported as AEs. Measured by body temperature.
Measured: Through study completion, up to 70 days
Change from baseline in tolerability assessment using Questionnaire
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.
Measured: Through study completion, up to 70 days
Change from baseline in performance status using Questionnaire
Performance status assessment using the Karnofsky Performance Scale Index. The scale is 0-100, with 0 reflecting a worse outcome.
Measured: Through study completion, up to 70 days
Secondary outcomes (7)
Pharmacokinetic parameters- Cmax
Subject to the development of suitable analytical methods, maximum plasma concentration will be determined.
Measured: Up to 3 years
Pharmacokinetic parameters- Tmax
Subject to the development of suitable analytical methods, time corresponding to the Cmax will be determined.
Measured: Up to 3 years
Pharmacokinetic parameters- AUC
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.
Measured: Up to 3 years
Pharmacokinetic parameters- T1/2/ el
Subject to the development of suitable analytical methods, elimination half-life will be determined.
Measured: Up to 3 years
Pharmacokinetic parameters- Vd
Subject to the development of suitable analytical methods, volume distribution will be determined.
Measured: Up to 3 years
Pharmacokinetic parameters- Clr
Subject to the development of suitable analytical methods, renal clearance will be determined.
Measured: Up to 3 years
Pharmacokinetic parameters- dose proportionality
Subject to the development of suitable analytical methods, dose proportionality will be determined.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start17 Mar 2022
- Primary completion25 May 2022
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiscomfortStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- SQ Innovation, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EB Medical Research, Quartesian
- Responsible party
- Sponsor
- Investigators
- Mazin AlHakim, MD, Principal investigator, EB FlevoResearch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296083
- Sponsor's protocol ID
- G3P-01-01
- Other IDs
- NL80001.028.21
- Acronym
- G3P-01-01
- Status last verified
- Jun 2022
- First submitted
- 8 Feb 2022
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05296083
- Acronym / sponsor ID
- G3P-01-01 / G3P-01-01
- Conditions
- Gastrointestinal Discomfort, Performance Status
- Keywords
- Gastrointestinal, Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- SQ Innovation, Inc.Industry (pharma, biotech, devices)
- Collaborators
- EB Medical Research, Quartesian
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 25 Mar 2022 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| G3P-01 50mg Dose Treatment Period 1 | Experimental | Dietary Supplement: G3P-01G3P-01 will be administered orally as a powdered mixed with water. Treatment Period one dose will be 50mg of IP. |
| G3P-01 500mg Dose Treatment Period 2 | Experimental | Dietary Supplement: G3P-01G3P-01 will be administered orally as a powdered mixed with water. Treatment Period two dose will be 500mg of IP. |
| G3P-01 1000mg Dose Treatment Period 3 | Experimental | Dietary Supplement: G3P-01G3P-01 will be administered orally as a powdered mixed with water. Treatment Period three dose will be 1000mg of IP. |
| G3P-01 2000mg Dose Treatment Period 4 | Experimental | Dietary Supplement: G3P-01G3P-01 will be administered orally as a powdered mixed with water. Treatment Period four dose will be 2000mg of IP. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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:
- Willing to adhere to the prohibitions and restrictions specified in the protocol;
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| G3P-01G3P-01 is a food-grade pectic product derived from squash. | Dietary supplement | G3P-01 1000mg Dose Treatment Period 3, G3P-01 2000mg Dose Treatment Period 4, G3P-01 500mg Dose Treatment Period 2, G3P-01 50mg Dose Treatment Period 1 |
Primary outcome
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
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
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.
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.
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,
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
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.
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.
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.
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.
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.
7 secondary outcomes
Pharmacokinetic parameters- Cmax
Time frame: Up to 3 years
Pharmacokinetic parameters- Tmax
Time frame: Up to 3 years
Pharmacokinetic parameters- AUC
Time frame: Up to 3 years
Pharmacokinetic parameters- T1/2/ el
Time frame: Up to 3 years
Pharmacokinetic parameters- Vd
Time frame: Up to 3 years
Pharmacokinetic parameters- Clr
Time frame: Up to 3 years
Pharmacokinetic parameters- dose proportionality
Time frame: Up to 3 years
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 13 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Mazin AlHakim, MD principal investigator
EB FlevoResearch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G3P-01 in people with Gastrointestinal Discomfort and Performance Status, run by SQ Innovation, Inc. at 1 site in Netherlands.
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 23 inclusion and 11 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 13 Jun 2022. 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 Netherlands. 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?
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). The study lists 11 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 13 Jun 2022.