Safety, Pharmacokinetic and Pharmacodynamic Study of the CDK 4/6 Inhibitor G1T28-1

Healthy Volunteers Clinical Trial

Official title:

First-In-Human Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Study of G1T28-1 in Healthy Male and Female Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02243150
• Other study ID #: G1T28-1-01
• Status: Completed
• Phase: Phase 1
• Start date: September 2014
• Est. completion date: December 18, 2015

Study information

• Verified date: June 2015
• Source: G1 Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This first-in-human (FIH) study will provide the first safety, PK, and PD data of G1T28-1 in humans and will allow further development of G1T28 1 in patients with cancer to reduce chemotherapy-induced myelosuppression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 18, 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy male and female volunteers, 18-60 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) and weighing at least 50 kg

• Non-smokers / non-users of nicotine containing products for at least the previous 3 months

• 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 examination, medical history review, ECGs (including QTcf interval > 450 msec), vital signs and laboratory tests (including positive test for HIV, hepatitis B and/or C)

• History of any serious allergic reaction to any medication

• Participated in a previous clinical trial with an investigational product in the last 60 days

• 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 and positive test for drug abuse

• Use of any systemic medication within the past 2 weeks, including use of herbal products

• Pregnant or lactating women

• Any other issue which, in the opinion of the PI, will make the subject ineligible for study participation

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• G1T28-1 (CDK 4/6 Inhibitor)

• Placebo

Locations

Country	Name	City	State
Netherlands	PRA Early Development Clinic	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
G1 Therapeutics, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	All Adverse events, including-clinical laboratory data, vital signs and ECGs will be analyzed in all subjects receiving study drug through 14 days post dose of study drug.	Up to day 14
Secondary	Pharmacokinetics of G1T28-1 in Plasma: Peak Plasma Concentration (Cmax)	The observed peak plasma concentration determined from the plasma concentration vs. time data	Day 1, Day 2, Day 3 and Day 4
Secondary	Pharmacokinetics of G1T28-1 in Plasma: Time to reach the observed peak plasma concentration (tmax)	The time to reach the observed peak plasma concentration from the plasma concentration vs. time data	Day 1, Day 2, Day 3 and Day 4
Secondary	Pharmacokinetics of G1T28-1 in Plasma: Area under the plasma concentration -time curve from 0-12 hrs (AUC 0-12)	Area under the plasma concentration-time curve from 0 to 12 hours post dosing, calculated by linear/log trapezoidal method	Day 1
Secondary	Pharmacokinetics of G1T28-1 in Plasma: Area under the plasma concentration- time curve from 0 to last (AUC 0-last)	Area under the plasma concentration-time curve from time 0 to time of last measurable concentration calculated by linear/log trapezoidal method	Day 1, Day 2, Day 3, Day 4
Secondary	Pharmacokinetics of G1T28-1 in Plasma: Area under the plasma concentration-time curve from time zero to infinity	Area under the concentration time curve from time zero extrapolated to infinity	Day 1, Day 2, Day 3, Day 4
Secondary	Pharmacokinetics of G1T28-1 in Plasma: terminal half life (T1/2)	Terminal half-life, defined as 0.693 divided by ?z?	Day 1
Secondary	Pharmacokinetics of G1T28-1 in Plasma: Terminal phase rate constant	Determined by linear regression of at least 3 points on the terminal phase of the log-linear plasma concentration-time curve.	Day 1
Secondary	Pharmacokinetics of G1T28-1 in Plasma: Clearance	Clearance after intravenous administration	Day 1
Secondary	Pharmacokinetics of G1T28-1 in Plasma: Volume of distribution	Volume of distribution in the terminal elimination phase	Day 1
Secondary	Pharmacodynamics-Whole Blood Ex Vivo Stimulation	Analysis of peripheral blood cell proliferation	Day 1
Secondary	Pharmacodynamic - Bone Marrow Analysis	Analysis of hematopoietic stem and progenitor cell (HSPC)	Day 1