Target engagement, tolerability Target engagement tolerability
Conditions
Interventions
Study intervention: G3P-01
Dose: 0mg (placebo), 100mg, 250mg or 1000mg once daily
Treatment duration: 30 days
Sponsors
General Practitioners Research Institute
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed