First-in-human phase I safety, pharmacokinetic, and pharmacodynamic study of G1T28-1 in healthy male and female subjects.

Completed

• Conditions: Cancer; 10027656; chemotherapy

• Registration Number: NL-OMON42109
• Lead Sponsor: G1 Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 58

Inclusion Criteria

healthy male or female
age 18 - 60 jaar, inclusive
BMI 18 - 32 kilogram/meter2
non smokers

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 3 months from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Assess the safety and tolerability of G1T28-1 administered IV.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Assess the pharmacokinetic (PK) profile of G1T28-1<br /><br>Assess potential pharmacodynamic (PD) markers of G1T28-1<br /><br>Define G1T28-1 dose(s) for further study<br /><br>Assess the bioavailability of orally administered G1T28-1 in a separate cohort<br /><br>of subjects</p><br>