This first-in-human (FIH) study will provide the first safety, PK, and PD data of G1T28-1 in humans and will allow further development of G1T28 1 in patients with cancer to reduce chemotherapy-induced myelosuppression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
53
PRA Early Development Clinic
Groningen, Netherlands
Adverse Events
All Adverse events, including-clinical laboratory data, vital signs and ECGs will be analyzed in all subjects receiving study drug through 14 days post dose of study drug.
Time frame: Up to day 14
Pharmacokinetics of G1T28-1 in Plasma: Peak Plasma Concentration (Cmax)
The observed peak plasma concentration determined from the plasma concentration vs. time data
Time frame: Day 1, Day 2, Day 3 and Day 4
Pharmacokinetics of G1T28-1 in Plasma: Time to reach the observed peak plasma concentration (tmax)
The time to reach the observed peak plasma concentration from the plasma concentration vs. time data
Time frame: Day 1, Day 2, Day 3 and Day 4
Pharmacokinetics of G1T28-1 in Plasma: Area under the plasma concentration -time curve from 0-12 hrs (AUC 0-12)
Area under the plasma concentration-time curve from 0 to 12 hours post dosing, calculated by linear/log trapezoidal method
Time frame: Day 1
Pharmacokinetics of G1T28-1 in Plasma: Area under the plasma concentration- time curve from 0 to last (AUC 0-last)
Area under the plasma concentration-time curve from time 0 to time of last measurable concentration calculated by linear/log trapezoidal method
Time frame: Day 1, Day 2, Day 3, Day 4
Pharmacokinetics of G1T28-1 in Plasma: Area under the plasma concentration-time curve from time zero to infinity
Area under the concentration time curve from time zero extrapolated to infinity
Time frame: Day 1, Day 2, Day 3, Day 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pharmacokinetics of G1T28-1 in Plasma: terminal half life (T1/2)
Terminal half-life, defined as 0.693 divided by λzλ
Time frame: Day 1
Pharmacokinetics of G1T28-1 in Plasma: Terminal phase rate constant
Determined by linear regression of at least 3 points on the terminal phase of the log-linear plasma concentration-time curve.
Time frame: Day 1
Pharmacokinetics of G1T28-1 in Plasma: Clearance
Clearance after intravenous administration
Time frame: Day 1
Pharmacokinetics of G1T28-1 in Plasma: Volume of distribution
Volume of distribution in the terminal elimination phase
Time frame: Day 1
Pharmacodynamics-Whole Blood Ex Vivo Stimulation
Analysis of peripheral blood cell proliferation
Time frame: Day 1
Pharmacodynamic - Bone Marrow Analysis
Analysis of hematopoietic stem and progenitor cell (HSPC)
Time frame: Day 1