Primary Objectives:1. To evaluate target engagement attributable to G3P-01 use in volunteers with elevated galectin-3 (>= 16.0ng/mL)2. To evaluate tolerability of G3P-01Secondary Objectives:1. To provide samples for research and development of…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Target engagement, tolerability
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Evidence of target engagement:
1. Evidence of galectin-3 target engagement based on statistical change from
baseline of pathway markers consistent with galectin-3 inhibition
2. Indication of dose-response effect on pathway markers
Tolerability of G3P-01:
1. Changes in the gastrointestinal symptom rating scale (GSRS)
2. Emerging signs or symptoms
3. Laboratory safety parameters (change from baseline or emergence of
clinically significant abnormal values)
Secondary outcome
1. To provide samples for research and development of analytical methods:
- To characterize G3P-01 and its effects on the human body
- For other exploratory scientific purpose related to the effects of
galectin-3 on the body.
Background summary
G3P-01 is an investigational pectin extracted, enriched and purified from
commercial squash puree intended for human consumption. Pectins are an
important constituent of fruits and vegetables, and health benefits are
attributed to its intake. Some of the health benefits of pectins are attributed
to inhibition of galectin-3. This study investigates if 30-days of G3P-01
intake in individuals with elevated galectin-3 induces biomarker changes that
can be attributed to target engagement.
Study objective
Primary Objectives:
1. To evaluate target engagement attributable to G3P-01 use in volunteers with
elevated galectin-3 (>= 16.0ng/mL)
2. To evaluate tolerability of G3P-01
Secondary Objectives:
1. To provide samples for research and development of analytical methods to
characterize G3P-01 and its effects on the human body and for other exploratory
scientific purpose related to the effects of galectin-3 on the body.
Study design
This study is a phase II randomized placebo-controlled dose ranging study in
adult volunteers. Selected volunteers in the Lifelines cohort study can opt-in
to have galectin-3 measured in their sample. Volunteers that meet inclusion
criteria will complete a Screening visit, Enrollment visit, a Treatment Phase,
a Completion visit and Follow-Up Phases.
The Screening Phase will be conducted on an outpatient basis between 14 and 1
day prior to first treatment. Participants that pass the screening phase will
be invited for an enrollment visit where blood and urine samples will be
collected. Subsequently, participants will be randomly assigned to one of four
groups for the Treatment Phase.
Participants will be 1:1:1:1 randomized into 1 of the 3 G3P-01 dosis or
placebo. The Treatment Phase will comprise of daily intake of the study product
(100mg, 250mg or 1000mg of G3P-01, or placebo) for a total of 30 days.
After 30 days, blood and urine samples are collected during a Completion visit.
Participants will be contacted by phone 30±2 days after completion for
follow-up.
Intervention
Study intervention: G3P-01
Dose: 0mg (placebo), 100mg, 250mg or 1000mg once daily
Treatment duration: 30 days
Study burden and risks
No G3P-01 specific health risks or concerns are known. Although unlikely
because of the low dose, the occurrence of GI symptoms commonly associated with
pectin intake cannot be excluded. Symptoms may include bloating, stool
softening, cramps and flatulence. Pectin-products including G3P-01 may offer
health benefits such as weight loss and lowered cholesterol levels, and G3P-01
may aid in the prevention of heart disease, chronic kidney disease and other
consequences of fibrotic processes. Risks are limited to risks associated with
common procedures such as venipuncture and study-related travel.
Prof. E.D. Wiersmastraat 5
Groningen 9713GH
NL
Prof. E.D. Wiersmastraat 5
Groningen 9713GH
NL
Listed location countries
Age
Inclusion criteria
- Lifelines participants who has opted in the Lifelines substudy and was found
to have plasma galactin-3 levels of 16 ng/ml or higher
- Male and female subjects >=45 and <=75 years of age
- Females will be non-pregnant, non-lactating, and have no intent to become
pregnant during the study period
- Able to participate in the study in the opinion of the Investigator.
- Has the ability to understand the requirements of the study and is willing to
comply with all study procedures.
- An Independent Ethics Committee or in Dutch Medisch-Ethische
Toetsingscommissie (METC) -approved informed consent is signed and dated prior
to any study-related activities.
Exclusion criteria
- Existing clinically significant concurrent medical condition which in the
opinion of the Investigator may interfere with the study.
- Clinically significant abnormal laboratory test values, as determined by the
Investigator, at Screening.
- Participation in a clinical trial of an investigational drug within 30 days
prior to Screening, or is currently participating in another trial of an
investigational drug, supplement or device.
- Donation of greater than 100 mL of either whole blood or plasma within 30
days prior to investigational product administration.
- An immediate family or household-members of study*s personnel.
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 | NL83767.056.23 |