NCT05353894

Effect of Food and Formulation on the Pharmacokinetics, Safety, and Tolerability of GNS561 After One Single Dose (50 and 200mg) in Healthy Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Genoscience Pharma · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

GNS561 is a drug used in preliminary phase 1b study for treatment of patients with primary and secondary liver cancer. The formulation used was oral capsule.The objective of this study in healthy volunteers is to compare pharmacokinetics, safety and tolerability of different formulations (tablets and capsules) and dosage (50 and 200mg) of GNS561 after single oral administration in first part and to evaluate the food effect on pharmacokinetics in second part.

Conditions

• Primary Liver Cancer

Interventions

Type	Name	Description
DRUG	GNS561 oral tablets and capsules	Two formulations and Two dosage will be compared

Timeline

• Start date: 2022-05-02
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2022-04-29
• Last updated: 2022-04-29

Locations

1 site across 1 country: France