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

June 13, 2017 updated by: G1 Therapeutics, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands
        • PRA Early Development Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Treatment Related Adverse Event, including Abnormal Laboratory Events
Time Frame: 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.
Up to Day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of G1T38: Maximum Plasma Concentration (Cmax)
Time Frame: Day 1, 2, 3, 4 and 5
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)
Time Frame: Day 1, 2, 3, 4 and 5
Area under the plasma concentration-time curve
Day 1, 2, 3, 4 and 5
Pharmacokinetics of G1T38: Plasma: terminal half life (T1/2)
Time Frame: Day 1, 2, 3, 4 and 5
G1T38: Plasma- terminal half life (T1/2)
Day 1, 2, 3, 4 and 5
Pharmacokinetics of G1T38: Plasma - Volume of distribution
Time Frame: Day 1, 2, 3, 4 and 5
Volume of distribution in the terminal elimination phase
Day 1, 2, 3, 4 and 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
G1 Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Regner Tiessen, MD, PRA Early Development Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 4, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • G1T38-01
  • 2016-001201-17 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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