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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42109

Enrollment

Registered

2014-08-04

Start date

2014-08-13

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer chemotherapy

Interventions

Single and single-dose period G1T28-1 or placebo by intravenous infusion.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Assess the safety and tolerability of G1T28-1 administered IV.	—

Secondary

Measure	Time frame
Assess the pharmacokinetic (PK) profile of G1T28-1 Assess potential pharmacodynamic (PD) markers of G1T28-1 Define G1T28-1 dose(s) for further study Assess the bioavailability of orally administered G1T28-1 in a separate cohort of subjects	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)