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First-in-Human Safety, PK, and Food Effect Study of Single Ascending Doses of G1T38 in Healthy Volunteers

NCT02821624 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2017-06-14

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

G1T38 (CDK 4/6 Inhibitor)

CDK 4/6 Inhibitor

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • G1 Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Regner Tiessen, MD · PRA Early Development Clinic

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-12-15
Completion
2017-04-04

Countries

  • Netherlands

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02821624 on ClinicalTrials.gov