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

Primary Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05353894
• Other study ID #: GNS561-CL-I-Q-0321
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 2, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: April 2022
• Source: Genoscience Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 27
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• BMI will be between 18 (inclusive) and 26 kg/m² (inclusive).
• Participants must be in good general health, with no significant medical history, have no clinically significant (CS) abnormalities on physical examination, vital signs, and 12-lead ECG at Screening and/or before administration of the first dose of study drug
• Have a Fridericia's correction factor for QT (QTcF) = 450 ms for male participants and = 470 ms for female participants on 12-lead ECG
• Women subjects of childbearing potential must have a negative serum/urine pregnancy test at screening and baseline
• Women subjects of childbearing potential and male subjects must agree to use adequate highly effective contraception for the duration of study participation and up to 6 months following completion of therapy
• Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Able to understand and provide written informed consent.

Exclusion Criteria:

• Pregnant or breast-feeding mothers
• Known allergic reaction to quinolone derivatives (e.g., quinine, choloroquine, mefloquine)
• Subjects with any clinically significant laboratory abnormality
• History of QT prolongation (QTc = 500 ms) or family history of long QT arrythmia or cardiac disease or bradycardia < 50/mn or uncorrected hypokalemia
• On going uncontrolled infection disease
• History of pre-existing retinopathy or maculopathy
• Participation in any investigational clinical investigation = 4 weeks prior to first planned dose of GNS561
• Malabsorption issues (e.g., gastric bypass or gastrectomy patients), current or history significant gastrointestinal diseases
• Patient with a mental or legal disability

Related Conditions & MeSH terms

• Primary Liver Cancer

Intervention

Drug:
• GNS561 oral tablets and capsules
Two formulations and Two dosage will be compared

Locations

Country	Name	City	State
France	Genoscience Pharma	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Genoscience Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events	adverse events	from first administration until 29 days
Primary	Maximum Plasma Concentration (Cmax)	blood samples at different time from GNS561 administration	Day 1, Day 2, Day 3, Day 4 and Day 7
Secondary	Maximum Plasma Concentration (Cmax)	blood samples at different time from GNS561 administration	Day 1, Day 2, Day 3, Day 4 and Day 7