Healthy Volunteers
Conditions
Brief summary
This first-in-human (FIH) study will provide the first safety and pharmacokinetic (PK) data for G1T38 in humans and will allow further development of G1T38 in patients with cancer.
Interventions
DRUGG1T38 (CDK 4/6 Inhibitor)
CDK 4/6 Inhibitor
DRUGPlacebo
Placebo
Sponsors
G1 Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female volunteers, 40-65 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) at screening, and weighing at least 50 kg * Nonusers of nicotine-containing products for at least the previous 3 months prior to dosing or nonsmokers * 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 examinations, medical history review, ECGs (QTcF interval \> 450 milliseconds for males and \>470 milliseconds for females), vital signs, and laboratory tests (including positive HIV, hepatitis B and C) * Participated in in a previous clinical study with an investigational product in the last 60 days * History of any serious allergic reaction to any medication * 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 * Pregnant or lactating women * Any other issues which, in the opinion of the PI, will make the subject ineligible for study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment Related Adverse Event, including Abnormal Laboratory Events | Up to Day 7 | All AEs, including clinical laboratory, vitals signs, physical examinations and ECGs will be analyzed in all subjects receiving study drug through 7 days post dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of G1T38: Maximum Plasma Concentration (Cmax) | Day 1, 2, 3, 4 and 5 | The observed peak plasma concentration determined from the plasma |
| Pharmacokinetics of G1T38: Area under Curve - plasma concentration (AUC) | Day 1, 2, 3, 4 and 5 | Area under the plasma concentration-time curve |
| Pharmacokinetics of G1T38: Plasma: terminal half life (T1/2) | Day 1, 2, 3, 4 and 5 | G1T38: Plasma- terminal half life (T1/2) |
| Pharmacokinetics of G1T38: Plasma - Volume of distribution | Day 1, 2, 3, 4 and 5 | Volume of distribution in the terminal elimination phase |
Countries
Netherlands
Outcome results
None listed