The primary objective of the study is:* To evaluate the safety and tolerability of ascending doses of G3-P01, a food-derived pectic product administered orally in healthy adult subjectThe secondary objectives of the study are:* To collect plasma and…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
safety and tolerance
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint(s):
* Number, severity, and nature of adverse events following the administration
of ascending doses of G3-P01:
o Number of participants with treatment emergent adverse events;
o Number of participants with clinically significant findings in physical
examinations reported
as adverse event;
o Number of participants with clinically significant change in clinical
laboratory results
reported as adverse event;
o Number of participants with clinically significant change in vital signs
reported as adverse event.
* Tolerability assessment following ascending doses of G3-P01 using the
Gastrointestinal Symptom Rating Scale (GSRS)
* Change from baseline in performance status using the Karnofsky Performance
Scale Index
Secondary outcome
Secondary endpoint(s):
* Subject to development of a suitable analytical method, the following PK
parameters on blood and urine samples following ascending doses of G3-P01:
o Maximum plasma concentration (Cmax);
o Time corresponding to the Cmax (Tmax);
o 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 postdose
(AUC0-24), from time zero to infinity (extrapolated) (AUC0-inf);
o Elimination half-life (T1/2 el.);
o Distribution volume (Vd);
o Renal clearance (Clr).
o Dose proportionality
Background summary
Galectins are a family of soluble mammalian *-galactoside-binding lectins
sharing highly conserved carbohydrate recognition domains (CRDs) consisting of
~130 amino acids (Barondes et al., 1994). Through their binding to specific
carbohydrate determinants, they play a fundamental role in human and animal
physiology and pathophysiology (Barrionuevo et al., 2007; Barrow et al., 2011;
Camby et al., 2006; Nakahara and Raz, 2008; Paclik et al., 2011).
G3-P01 is an investigational pectin-derived Gal-3 inhibitor purified from
organic, commercial squash puree intended for human consumption. G3-P01 is
extracted from squash puree by a water-soluble enzymatic process, requiring no
solvents, followed by ultrafiltration. The resulting product is an enriched,
natural product of pectic fragments that is being developed as a nutritional
therapy.
Study objective
The primary objective of the study is:
* To evaluate the safety and tolerability of ascending doses of G3-P01, a
food-derived pectic product administered orally in healthy adult subject
The secondary objectives of the study are:
* To collect plasma and urine samples for research and development of
analytical methods.
* To perform the plasma and urine pharmacokinetics (PK) profiling of G3-P01
after oral administration once suitable analytical methods become available.
Study design
This is an interventional, open-label, ascending dose study in 10 adult healthy
volunteers.
Intervention
G3P-01 (investigational product) will be administered as a single dose during
four treatment periods of 24 hours each. The doses will be ascending and will
be solubilized in 100mL of water.
Study burden and risks
Pectins are generally recognizes as safe (GRAS) and in non-clinical studies
have been found to be non-toxic. Participants will spend 4 days total in-unit
during the study. During this time, participants will be subject to about 20
blood draws.
20 Mall Rd Suite 220
Burlington 01803
US
20 Mall Rd Suite 220
Burlington 01803
US
Listed location countries
Age
Inclusion criteria
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.
Exclusion criteria
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80001.028.21 |