NCT02821624

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started May 2016

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2017

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

8 months

First QC Date

June 28, 2016

Last Update Submit

June 13, 2017

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to Day 7

Secondary Outcomes (4)

  • Pharmacokinetics of G1T38: Maximum Plasma Concentration (Cmax)

    Day 1, 2, 3, 4 and 5

  • Pharmacokinetics of G1T38: Area under Curve - plasma concentration (AUC)

    Day 1, 2, 3, 4 and 5

  • Pharmacokinetics of G1T38: Plasma: terminal half life (T1/2)

    Day 1, 2, 3, 4 and 5

  • Pharmacokinetics of G1T38: Plasma - Volume of distribution

    Day 1, 2, 3, 4 and 5

Study Arms (12)

Cohort 1

EXPERIMENTAL

G1T38 or placebo

Drug: G1T38 (CDK 4/6 Inhibitor)Drug: Placebo

Cohort 2

EXPERIMENTAL

G1T38 or placebo

Drug: G1T38 (CDK 4/6 Inhibitor)Drug: Placebo

Cohort 3

EXPERIMENTAL

G1T38 or placebo

Drug: G1T38 (CDK 4/6 Inhibitor)Drug: Placebo

Cohort 4

EXPERIMENTAL

G1T38 or placebo

Drug: G1T38 (CDK 4/6 Inhibitor)Drug: Placebo

Cohort 5

EXPERIMENTAL

G1T38 or placebo

Drug: G1T38 (CDK 4/6 Inhibitor)Drug: Placebo

Cohort 6

EXPERIMENTAL

G1T38 or placebo

Drug: G1T38 (CDK 4/6 Inhibitor)Drug: Placebo

Cohort 7

EXPERIMENTAL

G1T38 or placebo

Drug: G1T38 (CDK 4/6 Inhibitor)Drug: Placebo

Cohort 8

EXPERIMENTAL

G1T38 or placebo

Drug: G1T38 (CDK 4/6 Inhibitor)Drug: Placebo

Cohort 9 - Food Effect

EXPERIMENTAL

G1T38

Drug: G1T38 (CDK 4/6 Inhibitor)

Cohort 10

EXPERIMENTAL

G1T38 or placebo

Drug: G1T38 (CDK 4/6 Inhibitor)Drug: Placebo

Cohort 11

EXPERIMENTAL

G1T38 or placebo

Drug: G1T38 (CDK 4/6 Inhibitor)Drug: Placebo

Cohort 12

EXPERIMENTAL

G1T38 or placebo

Drug: G1T38 (CDK 4/6 Inhibitor)Drug: Placebo

Interventions

G1T38 (CDK 4/6 Inhibitor)DRUG

CDK 4/6 Inhibitor

Also known as: G1T38
Cohort 1Cohort 10Cohort 11Cohort 12Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6Cohort 7Cohort 8Cohort 9 - Food Effect
PlaceboDRUG

Placebo

Cohort 1Cohort 10Cohort 11Cohort 12Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6Cohort 7Cohort 8

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRA Early Development Clinic

Groningen, Netherlands

Location

Study Officials

  • Regner Tiessen, MD

    PRA Early Development Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2016

First Posted

July 1, 2016

Study Start

May 1, 2016

Primary Completion

December 15, 2016

Study Completion

April 4, 2017

Last Updated

June 14, 2017

Record last verified: 2017-06

Locations

NL(1)