Status:
COMPLETED
Safety, Pharmacokinetic and Pharmacodynamic Study of the CDK 4/6 Inhibitor G1T28-1
Lead Sponsor:
G1 Therapeutics, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2015
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT02243150
Start Date
September 1 2014
End Date
December 18 2015
Last Update
December 17 2018
Active Locations (1)
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1
PRA Early Development Clinic
Groningen, Netherlands