First-in-Human Safety, PK, and Food Effect Study of Single Ascending Doses of G1T38 in Healthy Volunteers

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