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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: G1T38 (CDK 4/6 Inhibitor); Drug: Placebo

• Registration Number: NCT02821624
• Lead Sponsor: G1 Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-06-30
• Study First Posted: 2016-07-01
• Primary Completion: 2016-12-15
• Study Completion: 2017-04-04
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	G1T38 (CDK 4/6 Inhibitor)	G1T38 or placebo
Cohort 1	Placebo	G1T38 or placebo
Cohort 2	G1T38 (CDK 4/6 Inhibitor)	G1T38 or placebo
Cohort 5	G1T38 (CDK 4/6 Inhibitor)	G1T38 or placebo
Cohort 5	Placebo	G1T38 or placebo
Cohort 2	Placebo	G1T38 or placebo
Cohort 3	G1T38 (CDK 4/6 Inhibitor)	G1T38 or placebo
Cohort 3	Placebo	G1T38 or placebo
Cohort 4	G1T38 (CDK 4/6 Inhibitor)	G1T38 or placebo
Cohort 4	Placebo	G1T38 or placebo
Cohort 6	G1T38 (CDK 4/6 Inhibitor)	G1T38 or placebo
Cohort 6	Placebo	G1T38 or placebo
Cohort 7	G1T38 (CDK 4/6 Inhibitor)	G1T38 or placebo
Cohort 7	Placebo	G1T38 or placebo
Cohort 8	G1T38 (CDK 4/6 Inhibitor)	G1T38 or placebo
Cohort 8	Placebo	G1T38 or placebo
Cohort 9 - Food Effect	G1T38 (CDK 4/6 Inhibitor)	G1T38
Cohort 10	G1T38 (CDK 4/6 Inhibitor)	G1T38 or placebo
Cohort 10	Placebo	G1T38 or placebo
Cohort 11	G1T38 (CDK 4/6 Inhibitor)	G1T38 or placebo
Cohort 11	Placebo	G1T38 or placebo
Cohort 12	G1T38 (CDK 4/6 Inhibitor)	G1T38 or placebo
Cohort 12	Placebo	G1T38 or placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Pharmacokinetics of G1T38: Plasma - Volume of distribution	Day 1, 2, 3, 4 and 5	Volume of distribution in the terminal elimination phase
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)

Trial Locations

Locations (1)

PRA Early Development Clinic; 🇳🇱 Groningen, Netherlands