Healthy VolunteersPhase 1NCT02821624
First-in-Human Safety, PK, and Food Effect Study of Single Ascending Doses of G1T38 in Healthy Volunteers
A Phase 1 study testing G1T38 (CDK 4/6 Inhibitor) in people with Healthy Volunteers, run by G1 Therapeutics, Inc. at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- G1T38 (CDK 4/6 Inhibitor)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2016to 4 Apr 2017
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- G1T38 (CDK 4/6 Inhibitor), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G1T38 (CDK 4/6 Inhibitor)Drug
Also called G1T38
CDK 4/6 Inhibitor
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | G1T38 or placebo Receives: Drug: G1T38 (CDK 4/6 Inhibitor); Drug: Placebo |
| Cohort 2 | Experimental | G1T38 or placebo Receives: Drug: G1T38 (CDK 4/6 Inhibitor); Drug: Placebo |
| Cohort 3 | Experimental | G1T38 or placebo Receives: Drug: G1T38 (CDK 4/6 Inhibitor); Drug: Placebo |
| Cohort 4 | Experimental | G1T38 or placebo Receives: Drug: G1T38 (CDK 4/6 Inhibitor); Drug: Placebo |
| Cohort 5 | Experimental | G1T38 or placebo Receives: Drug: G1T38 (CDK 4/6 Inhibitor); Drug: Placebo |
| Cohort 6 | Experimental | G1T38 or placebo Receives: Drug: G1T38 (CDK 4/6 Inhibitor); Drug: Placebo |
| Cohort 7 | Experimental | G1T38 or placebo Receives: Drug: G1T38 (CDK 4/6 Inhibitor); Drug: Placebo |
| Cohort 8 | Experimental | G1T38 or placebo Receives: Drug: G1T38 (CDK 4/6 Inhibitor); Drug: Placebo |
| Cohort 9 - Food Effect | Experimental | G1T38 Receives: Drug: G1T38 (CDK 4/6 Inhibitor) |
| Cohort 10 | Experimental | G1T38 or placebo Receives: Drug: G1T38 (CDK 4/6 Inhibitor); Drug: Placebo |
| Cohort 11 | Experimental | G1T38 or placebo Receives: Drug: G1T38 (CDK 4/6 Inhibitor); Drug: Placebo |
| Cohort 12 | Experimental | G1T38 or placebo Receives: Drug: G1T38 (CDK 4/6 Inhibitor); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment Related Adverse Event, including Abnormal Laboratory Events
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.
Measured: Up to Day 7
Secondary outcomes (4)
Pharmacokinetics of G1T38: Maximum Plasma Concentration (Cmax)
The observed peak plasma concentration determined from the plasma
Measured: Day 1, 2, 3, 4 and 5
Pharmacokinetics of G1T38: Area under Curve - plasma concentration (AUC)
Area under the plasma concentration-time curve
Measured: Day 1, 2, 3, 4 and 5
Pharmacokinetics of G1T38: Plasma: terminal half life (T1/2)
G1T38: Plasma- terminal half life (T1/2)
Measured: Day 1, 2, 3, 4 and 5
Pharmacokinetics of G1T38: Plasma - Volume of distribution
Volume of distribution in the terminal elimination phase
Measured: Day 1, 2, 3, 4 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startMay 2016
- Primary completion15 Dec 2016
- Study completion4 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- G1 Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Regner Tiessen, MD, Principal investigator, PRA Early Development Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821624
- Sponsor's protocol ID
- G1T38-01
- Other IDs
- 2016-001201-17, 2016
- Status last verified
- Jun 2017
- First submitted
- 28 Jun 2016
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human Phase 1 Safety, Pharmacokinetic, and Food Effect Study of Single Ascending Doses of G1T38 in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT02821624
- Acronym / sponsor ID
- G1T38-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- G1 Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 4 Apr 2017 (actual)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: G1T38 (CDK 4/6 Inhibitor), Drug: PlaceboG1T38 or placebo |
| Cohort 2 | Experimental | Drug: G1T38 (CDK 4/6 Inhibitor), Drug: PlaceboG1T38 or placebo |
| Cohort 3 | Experimental | Drug: G1T38 (CDK 4/6 Inhibitor), Drug: PlaceboG1T38 or placebo |
| Cohort 4 | Experimental | Drug: G1T38 (CDK 4/6 Inhibitor), Drug: PlaceboG1T38 or placebo |
| Cohort 5 | Experimental | Drug: G1T38 (CDK 4/6 Inhibitor), Drug: PlaceboG1T38 or placebo |
| Cohort 6 | Experimental | Drug: G1T38 (CDK 4/6 Inhibitor), Drug: PlaceboG1T38 or placebo |
| Cohort 7 | Experimental | Drug: G1T38 (CDK 4/6 Inhibitor), Drug: PlaceboG1T38 or placebo |
| Cohort 8 | Experimental | Drug: G1T38 (CDK 4/6 Inhibitor), Drug: PlaceboG1T38 or placebo |
| Cohort 9 - Food Effect | Experimental | Drug: G1T38 (CDK 4/6 Inhibitor)G1T38 |
| Cohort 10 | Experimental | Drug: G1T38 (CDK 4/6 Inhibitor), Drug: PlaceboG1T38 or placebo |
| Cohort 11 | Experimental | Drug: G1T38 (CDK 4/6 Inhibitor), Drug: PlaceboG1T38 or placebo |
| Cohort 12 | Experimental | Drug: G1T38 (CDK 4/6 Inhibitor), Drug: PlaceboG1T38 or placebo |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G1T38 (CDK 4/6 Inhibitor)Also: G1T38CDK 4/6 Inhibitor | Drug | Cohort 1, Cohort 10, Cohort 11, Cohort 12, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8, Cohort 9 - Food Effect |
| PlaceboPlacebo | Drug | Cohort 1, Cohort 10, Cohort 11, Cohort 12, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8 |
Primary outcome
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.
4 secondary outcomes
Pharmacokinetics of G1T38: Maximum Plasma Concentration (Cmax)
Time frame: 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
Pharmacokinetics of G1T38: Plasma: terminal half life (T1/2)
Time frame: Day 1, 2, 3, 4 and 5
Pharmacokinetics of G1T38: Plasma - Volume of distribution
Time frame: Day 1, 2, 3, 4 and 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Individual participant dataSharing planned: Undecided
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Regner Tiessen, MD principal investigator
PRA Early Development Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing G1T38 (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 7 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 14 Jun 2017. 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?
Number of Treatment Related Adverse Event, including Abnormal Laboratory Events (time frame: Up to Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2017.