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
- Conditions
- safetysafety and toleranceadverse events
- Registration Number
- NL-OMON51278
- Lead Sponsor
- G3P, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
1. Male or female, aged * 18 to < 65 years;
2. Healthy volunteers, as determined by a comprehensive clinical assessment
performed at screening (medical history, vital signs, clinical laboratory
testing, ECG, and general physical examination);
3. Maintains a regular (mixed or vegetarian/vegan) diet.
4. 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;
5. Willing to adhere to the prohibitions and restrictions specified in the
protocol;
6. 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.
1. 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;
2. Clinically significant abnormal laboratory test values at screening, as
determined by the Investigator;
3. 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.
4. Any positive urine drug screen or alcohol test at Screening or clinic
admission.
5. 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.
6. History of alcohol abuse within 6 months prior to Screening and/or signs or
symptoms of alcoholism, as determined by the Investigator.
7. Positive test for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human
Immunodeficiency Virus (HIV);
8. Participation in another clinical trial of an investigational drug (or
medical device), or investigational food supplement within 30 days prior to
screening, or currently participating in another trial of an investigational
drug (or medical device), or food supplement;
9. Donation of greater than 100 mL of either whole blood or plasma within 30
days prior to investigational product administration.
10. 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.
11. Traveled via airplane or cruise ship within the last 14 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint(s):<br /><br>* Number, severity, and nature of adverse events following the administration<br /><br>of ascending doses of G3-P01:<br /><br>o Number of participants with treatment emergent adverse events;<br /><br>o Number of participants with clinically significant findings in physical<br /><br>examinations reported<br /><br>as adverse event;<br /><br>o Number of participants with clinically significant change in clinical<br /><br>laboratory results<br /><br>reported as adverse event;<br /><br>o Number of participants with clinically significant change in vital signs<br /><br>reported as adverse event.<br /><br>* Tolerability assessment following ascending doses of G3-P01 using the<br /><br>Gastrointestinal Symptom Rating Scale (GSRS)<br /><br>* Change from baseline in performance status using the Karnofsky Performance<br /><br>Scale Index</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoint(s):<br /><br>* Subject to development of a suitable analytical method, the following PK<br /><br>parameters on blood and urine samples following ascending doses of G3-P01:<br /><br>o Maximum plasma concentration (Cmax);<br /><br>o Time corresponding to the Cmax (Tmax);<br /><br>o Area under the plasma concentration-time curve (AUC): from time zero to the<br /><br>last non-zero concentration (AUC0-t), from time zero till 24-hours postdose<br /><br>(AUC0-24), from time zero to infinity (extrapolated) (AUC0-inf);<br /><br>o Elimination half-life (T1/2 el.);<br /><br>o Distribution volume (Vd);<br /><br>o Renal clearance (Clr).<br /><br>o Dose proportionality</p><br>