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Completed

NCT Number: NCT02243150

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Early Development Clinic

Groningen, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

G1T28-1 (CDK 4/6 Inhibitor)

Drug

Placebo

Drug

Primary outcomes

  1. Adverse Events

    Time frame: Up to day 14

    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.

Secondary outcomes

  1. Pharmacokinetics of G1T28-1 in Plasma: Peak Plasma Concentration (Cmax)

    Time frame: Day 1, Day 2, Day 3 and Day 4

    The observed peak plasma concentration determined from the plasma concentration vs. time data

  2. Pharmacokinetics of G1T28-1 in Plasma: Time to reach the observed peak plasma concentration (tmax)

    Time frame: Day 1, Day 2, Day 3 and Day 4

    The time to reach the observed peak plasma concentration from the plasma concentration vs. time data

  3. Pharmacokinetics of G1T28-1 in Plasma: Area under the plasma concentration -time curve from 0-12 hrs (AUC 0-12)

    Time frame: Day 1

    Area under the plasma concentration-time curve from 0 to 12 hours post dosing, calculated by linear/log trapezoidal method

  4. Pharmacokinetics of G1T28-1 in Plasma: Area under the plasma concentration- time curve from 0 to last (AUC 0-last)

    Time frame: Day 1, Day 2, Day 3, Day 4

    Area under the plasma concentration-time curve from time 0 to time of last measurable concentration calculated by linear/log trapezoidal method

  5. Pharmacokinetics of G1T28-1 in Plasma: Area under the plasma concentration-time curve from time zero to infinity

    Time frame: Day 1, Day 2, Day 3, Day 4

    Area under the concentration time curve from time zero extrapolated to infinity

  6. Pharmacokinetics of G1T28-1 in Plasma: terminal half life (T1/2)

    Time frame: Day 1

    Terminal half-life, defined as 0.693 divided by λzλ

  7. Pharmacokinetics of G1T28-1 in Plasma: Terminal phase rate constant

    Time frame: Day 1

    Determined by linear regression of at least 3 points on the terminal phase of the log-linear plasma concentration-time curve.

  8. Pharmacokinetics of G1T28-1 in Plasma: Clearance

    Time frame: Day 1

    Clearance after intravenous administration

  9. Pharmacokinetics of G1T28-1 in Plasma: Volume of distribution

    Time frame: Day 1

    Volume of distribution in the terminal elimination phase

  10. Pharmacodynamics-Whole Blood Ex Vivo Stimulation

    Time frame: Day 1

    Analysis of peripheral blood cell proliferation

  11. Pharmacodynamic - Bone Marrow Analysis

    Time frame: Day 1

    Analysis of hematopoietic stem and progenitor cell (HSPC)

Sponsors and collaborators

Lead sponsor

G1 Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 17, 2014
Registry last updated
Dec 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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