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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-04-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

G1T38 or placebo

Group Type EXPERIMENTAL

G1T38 (CDK 4/6 Inhibitor)

Intervention Type DRUG

CDK 4/6 Inhibitor

Placebo

Intervention Type DRUG

Placebo

Cohort 2

G1T38 or placebo

Group Type EXPERIMENTAL

G1T38 (CDK 4/6 Inhibitor)

Intervention Type DRUG

CDK 4/6 Inhibitor

Placebo

Intervention Type DRUG

Placebo

Cohort 3

G1T38 or placebo

Group Type EXPERIMENTAL

G1T38 (CDK 4/6 Inhibitor)

Intervention Type DRUG

CDK 4/6 Inhibitor

Placebo

Intervention Type DRUG

Placebo

Cohort 4

G1T38 or placebo

Group Type EXPERIMENTAL

G1T38 (CDK 4/6 Inhibitor)

Intervention Type DRUG

CDK 4/6 Inhibitor

Placebo

Intervention Type DRUG

Placebo

Cohort 5

G1T38 or placebo

Group Type EXPERIMENTAL

G1T38 (CDK 4/6 Inhibitor)

Intervention Type DRUG

CDK 4/6 Inhibitor

Placebo

Intervention Type DRUG

Placebo

Cohort 6

G1T38 or placebo

Group Type EXPERIMENTAL

G1T38 (CDK 4/6 Inhibitor)

Intervention Type DRUG

CDK 4/6 Inhibitor

Placebo

Intervention Type DRUG

Placebo

Cohort 7

G1T38 or placebo

Group Type EXPERIMENTAL

G1T38 (CDK 4/6 Inhibitor)

Intervention Type DRUG

CDK 4/6 Inhibitor

Placebo

Intervention Type DRUG

Placebo

Cohort 8

G1T38 or placebo

Group Type EXPERIMENTAL

G1T38 (CDK 4/6 Inhibitor)

Intervention Type DRUG

CDK 4/6 Inhibitor

Placebo

Intervention Type DRUG

Placebo

Cohort 9 - Food Effect

G1T38

Group Type EXPERIMENTAL

G1T38 (CDK 4/6 Inhibitor)

Intervention Type DRUG

CDK 4/6 Inhibitor

Cohort 10

G1T38 or placebo

Group Type EXPERIMENTAL

G1T38 (CDK 4/6 Inhibitor)

Intervention Type DRUG

CDK 4/6 Inhibitor

Placebo

Intervention Type DRUG

Placebo

Cohort 11

G1T38 or placebo

Group Type EXPERIMENTAL

G1T38 (CDK 4/6 Inhibitor)

Intervention Type DRUG

CDK 4/6 Inhibitor

Placebo

Intervention Type DRUG

Placebo

Cohort 12

G1T38 or placebo

Group Type EXPERIMENTAL

G1T38 (CDK 4/6 Inhibitor)

Intervention Type DRUG

CDK 4/6 Inhibitor

Placebo

Intervention Type DRUG

Placebo

Interventions

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G1T38 (CDK 4/6 Inhibitor)

CDK 4/6 Inhibitor

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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G1T38

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes