Title
Safety, Pharmacokinetic and Pharmacodynamic Study of the CDK 4/6 Inhibitor G1T28-1
First-In-Human Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Study of G1T28-1 in Healthy Male and Female Subjects
Phase
Phase 1Lead Sponsor
G1 Therapeutics, Inc.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Healthy VolunteersIntervention/Treatment
trilaciclib ...Study Participants
53This 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.
6mg/m2 of G1T28-1 or placebo will be administered in 50mL of 5% dextrose by IV infusion
Dose of G1T28-1 or placebo will be determined based on the safety and PK data from Cohort 1; G1T28-1 or placebo will be administered in 50mL of 5% dextrose by IV infusion.
Dose of G1T28-1 or placebo will be determined based on the safety and PK data from Cohort 2; G1T28-1 or placebo will be administered in 50mL of 5% dextrose by IV infusion.
Dose of G1T28-1 or placebo will be determined based on the safety and PK data from Cohort 3; G1T28-1 or placebo will be administered in 50mL of 5% dextrose by IV infusion.
Dose of G1T28-1 or placebo will be determined based on the safety and PK data from Cohort 4; G1T28-1 or placebo will be administered in 50mL of 5% dextrose by IV infusion. Subjects from this cohort may be selected to participate in the Whole Blood Ex-Vivo Stimulation group.
Dose of G1T28-1 or placebo will be determined based on the safety and PK data from Cohort 5; G1T28-1 or placebo will be administered in 50mL of 5% dextrose by IV infusion. Subjects from this cohort may be selected to participate in the Whole Blood Ex-Vivo Stimulation group.
All subjects in this cohort will receive active drug, G1T28-1. Dose of G1T28-1 will be determined based on the safety and PK data from previous cohorts. G1T28-1 will be administered in 50mL of 5% dextrose by IV infusion. Subjects in this cohort will be selected for the Ex-Vivo Stimulation group and will have a one time bone marrow aspirate at one of the following time points: pre dose, 12 or 24 hours post dose.
Inclusion Criteria: Healthy male and female volunteers, 18-60 years of age; no clinically significant findings reported following detailed physical examination, medical history, vital signs, clinical laboratory tests, and ECGs as deemed by the PI Body mass index (BMI) in the range of 18 to 32 kg/m2 (inclusive) and weighing at least 50 kg Non-smokers / non-users of nicotine containing products for at least the previous 3 months Agreement to use birth control during the study and 3 months post last visit Able to comply with all protocol requirements and procedures Exclusion Criteria: Clinically significant abnormalities found during physical examination, medical history review, ECGs (including QTcf interval > 450 msec), vital signs and laboratory tests (including positive test for HIV, hepatitis B and/or C) History of any serious allergic reaction to any medication Participated in a previous clinical trial with an investigational product in the last 60 days Any blood or plasma donation or other loss of blood at a volume exceeding 500 mL within 3 months before dosing History of drug or alcohol abuse in the last 2 years and positive test for drug abuse Use of any systemic medication within the past 2 weeks, including use of herbal products Pregnant or lactating women Any other issue which, in the opinion of the PI, will make the subject ineligible for study participation
