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

First-in-Human Phase 1 Safety, Pharmacokinetic, and Food Effect Study of Single Ascending Doses of G1T38 in Healthy Male and Female Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: G1T38 (CDK 4/6 Inhibitor)

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • PRA Early Development Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; G1T38 or placebo	Drug: Placebo; Placebo; Drug: G1T38 (CDK 4/6 Inhibitor); CDK 4/6 Inhibitor; Other Names: G1T38
Experimental: Cohort 2; G1T38 or placebo	Drug: Placebo; Placebo; Drug: G1T38 (CDK 4/6 Inhibitor); CDK 4/6 Inhibitor; Other Names: G1T38
Experimental: Cohort 3; G1T38 or placebo	Drug: Placebo; Placebo; Drug: G1T38 (CDK 4/6 Inhibitor); CDK 4/6 Inhibitor; Other Names: G1T38
Experimental: Cohort 4; G1T38 or placebo	Drug: Placebo; Placebo; Drug: G1T38 (CDK 4/6 Inhibitor); CDK 4/6 Inhibitor; Other Names: G1T38
Experimental: Cohort 5; G1T38 or placebo	Drug: Placebo; Placebo; Drug: G1T38 (CDK 4/6 Inhibitor); CDK 4/6 Inhibitor; Other Names: G1T38
Experimental: Cohort 6; G1T38 or placebo	Drug: Placebo; Placebo; Drug: G1T38 (CDK 4/6 Inhibitor); CDK 4/6 Inhibitor; Other Names: G1T38
Experimental: Cohort 7; G1T38 or placebo	Drug: Placebo; Placebo; Drug: G1T38 (CDK 4/6 Inhibitor); CDK 4/6 Inhibitor; Other Names: G1T38
Experimental: Cohort 8; G1T38 or placebo	Drug: Placebo; Placebo; Drug: G1T38 (CDK 4/6 Inhibitor); CDK 4/6 Inhibitor; Other Names: G1T38
Experimental: Cohort 9 - Food Effect; G1T38	Drug: G1T38 (CDK 4/6 Inhibitor); CDK 4/6 Inhibitor; Other Names: G1T38
Experimental: Cohort 10; G1T38 or placebo	Drug: Placebo; Placebo; Drug: G1T38 (CDK 4/6 Inhibitor); CDK 4/6 Inhibitor; Other Names: G1T38
Experimental: Cohort 11; G1T38 or placebo	Drug: Placebo; Placebo; Drug: G1T38 (CDK 4/6 Inhibitor); CDK 4/6 Inhibitor; Other Names: G1T38
Experimental: Cohort 12; G1T38 or placebo	Drug: Placebo; Placebo; Drug: G1T38 (CDK 4/6 Inhibitor); CDK 4/6 Inhibitor; Other Names: G1T38

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Treatment Related Adverse Event, including Abnormal Laboratory Events	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.	Up to Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of G1T38: Maximum Plasma Concentration (Cmax)	The observed peak plasma concentration determined from the plasma	Day 1, 2, 3, 4 and 5
Pharmacokinetics of G1T38: Area under Curve - plasma concentration (AUC)	Area under the plasma concentration-time curve	Day 1, 2, 3, 4 and 5
Pharmacokinetics of G1T38: Plasma: terminal half life (T1/2)	G1T38: Plasma- terminal half life (T1/2)	Day 1, 2, 3, 4 and 5
Pharmacokinetics of G1T38: Plasma - Volume of distribution	Volume of distribution in the terminal elimination phase	Day 1, 2, 3, 4 and 5

Collaborators and Investigators

• Sponsor: G1 Therapeutics, Inc.
• Investigators: Principal Investigator: Regner Tiessen, MD, PRA Early Development Clinic

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): December 15, 2016
• Study Completion (Actual): April 4, 2017

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (Estimate): July 1, 2016

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 13, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: G1T38-01; 2016-001201-17 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided