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

G1 Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: G1T38 (CDK 4/6 Inhibitor); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02821624

2016-001201-17 (EudraCT Number)

G1T38-01

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 12 patient groups

Cohort 1

Experimental group

Description:

G1T38 or placebo

Treatment:

Drug: Placebo

Drug: G1T38 (CDK 4/6 Inhibitor)

Cohort 2

Experimental group

Description:

G1T38 or placebo

Treatment:

Drug: Placebo

Drug: G1T38 (CDK 4/6 Inhibitor)

Cohort 3

Experimental group

Description:

G1T38 or placebo

Treatment:

Drug: Placebo

Drug: G1T38 (CDK 4/6 Inhibitor)

Cohort 4

Experimental group

Description:

G1T38 or placebo

Treatment:

Drug: Placebo

Drug: G1T38 (CDK 4/6 Inhibitor)

Cohort 5

Experimental group

Description:

G1T38 or placebo

Treatment:

Drug: Placebo

Drug: G1T38 (CDK 4/6 Inhibitor)

Cohort 6

Experimental group

Description:

G1T38 or placebo

Treatment:

Drug: Placebo

Drug: G1T38 (CDK 4/6 Inhibitor)

Cohort 7

Experimental group

Description:

G1T38 or placebo

Treatment:

Drug: Placebo

Drug: G1T38 (CDK 4/6 Inhibitor)

Cohort 8

Experimental group

Description:

G1T38 or placebo

Treatment:

Drug: Placebo

Drug: G1T38 (CDK 4/6 Inhibitor)

Cohort 9 - Food Effect

Experimental group

Description:

G1T38

Treatment:

Drug: G1T38 (CDK 4/6 Inhibitor)

Cohort 10

Experimental group

Description:

G1T38 or placebo

Treatment:

Drug: Placebo

Drug: G1T38 (CDK 4/6 Inhibitor)

Cohort 11

Experimental group

Description:

G1T38 or placebo

Treatment:

Drug: Placebo

Drug: G1T38 (CDK 4/6 Inhibitor)

Cohort 12

Experimental group

Description:

G1T38 or placebo

Treatment:

Drug: Placebo

Drug: G1T38 (CDK 4/6 Inhibitor)