AzTrials
AzTrials

Healthy VolunteersPhase 1NCT02243150

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

A Phase 1 study testing G1T28-1 (CDK 4/6 Inhibitor) in people with Healthy Volunteers, run by G1 Therapeutics, Inc. at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
G1T28-1 (CDK 4/6 Inhibitor)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
53 participants
Where
1 siteNetherlands
Study dates
Sep 2014to 18 Dec 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • PRA Early Development Clinic

    Groningen

Other trials in Netherlands

About this study

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

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.

Being tested
G1T28-1 (CDK 4/6 Inhibitor), Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • G1T28-1 (CDK 4/6 Inhibitor)Drug

  • PlaceboDrug

Study groups in NCT02243150
Study groupRoleWhat they receive
Cohort 1Experimental6mg/m2 of G1T28-1 or placebo will be administered in 50mL of 5% dextrose by IV infusion
Receives: Drug: G1T28-1 (CDK 4/6 Inhibitor); Drug: Placebo
Cohort 2ExperimentalDose of G1T28-1 or placebo will be determined based on the safety and PK data from Cohort 1; G1T28-1 or placebo will be administered in 50mL of 5% dextrose by IV infusion.
Receives: Drug: G1T28-1 (CDK 4/6 Inhibitor); Drug: Placebo
Cohort 3ExperimentalDose of G1T28-1 or placebo will be determined based on the safety and PK data from Cohort 2; G1T28-1 or placebo will be administered in 50mL of 5% dextrose by IV infusion.
Receives: Drug: G1T28-1 (CDK 4/6 Inhibitor); Drug: Placebo
Cohort 4ExperimentalDose of G1T28-1 or placebo will be determined based on the safety and PK data from Cohort 3; G1T28-1 or placebo will be administered in 50mL of 5% dextrose by IV infusion.
Receives: Drug: G1T28-1 (CDK 4/6 Inhibitor); Drug: Placebo
Cohort 5ExperimentalDose of G1T28-1 or placebo will be determined based on the safety and PK data from Cohort 4; G1T28-1 or placebo will be administered in 50mL of 5% dextrose by IV infusion. Subjects from this cohort may be selected to participate in the Whole Blood Ex-Vivo Stimulation group.
Receives: Drug: G1T28-1 (CDK 4/6 Inhibitor); Drug: Placebo
Cohort 6ExperimentalDose of G1T28-1 or placebo will be determined based on the safety and PK data from Cohort 5; G1T28-1 or placebo will be administered in 50mL of 5% dextrose by IV infusion. Subjects from this cohort may be selected to participate in the Whole Blood Ex-Vivo Stimulation group.
Receives: Drug: G1T28-1 (CDK 4/6 Inhibitor); Drug: Placebo
Cohort 7 - Bone Marrow CohortExperimentalAll subjects in this cohort will receive active drug, G1T28-1. Dose of G1T28-1 will be determined based on the safety and PK data from previous cohorts. G1T28-1 will be administered in 50mL of 5% dextrose by IV infusion. Subjects in this cohort will be selected for the Ex-Vivo Stimulation group and will have a one time bone marrow aspirate at one of the following time points: pre dose, 12 or 24 hours post dose.
Receives: Drug: G1T28-1 (CDK 4/6 Inhibitor)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to day 14

Secondary outcomes (11)

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

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

    Measured: Day 1, Day 2, Day 3 and Day 4

  2. 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

    Measured: Day 1, Day 2, Day 3 and Day 4

  3. 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

    Measured: Day 1

  4. 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

    Measured: Day 1, Day 2, Day 3, Day 4

  5. 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

    Measured: Day 1, Day 2, Day 3, Day 4

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

    Terminal half-life, defined as 0.693 divided by λzλ

    Measured: Day 1

  7. 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.

    Measured: Day 1

  8. Pharmacokinetics of G1T28-1 in Plasma: Clearance

    Clearance after intravenous administration

    Measured: Day 1

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

    Volume of distribution in the terminal elimination phase

    Measured: Day 1

  10. Pharmacodynamics-Whole Blood Ex Vivo Stimulation

    Analysis of peripheral blood cell proliferation

    Measured: Day 1

  11. Pharmacodynamic - Bone Marrow Analysis

    Analysis of hematopoietic stem and progenitor cell (HSPC)

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionFeb 2015
  4. Study completion18 Dec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02243150
Sponsor's protocol ID
G1T28-1-01
Status last verified
Jun 2015
First submitted
9 Sep 2014
Last updated
17 Dec 2018
Results posted
No
Data monitoring committee
No

Publications

  • Li C, Hart L, Owonikoko TK, Aljumaily R, Rocha Lima CM, Conkling PR, Webb RT, Jotte RM, Schuster S, Edenfield WJ, Smith DA, Sale M, Roberts PJ, Malik RK, Sorrentino JA. Trilaciclib dose selection: an integrated pharmacokinetic and pharmacodynamic analysis of preclinical data and Phase Ib/IIa studies in patients with extensive-stage small cell lung cancer. Cancer Chemother Pharmacol. 2021 May;87(5):689-700. doi: 10.1007/s00280-021-04239-9. Epub 2021 Feb 17.

    PubMed 33595690

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing G1T28-1 (CDK 4/6 Inhibitor) in people with Healthy Volunteers, run by G1 Therapeutics, Inc. at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: Up to day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02243150, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in