safety and tolerance adverse events safety
Conditions
Interventions
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.
Sponsors
G3P, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, aged * 18 to
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Outcome results
None listed