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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Liver Cancer
• Intervention / Treatment: Drug: GNS561 oral tablets and capsules

• Study Type: Interventional
• Enrollment (Anticipated): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13006
    • Genoscience Pharma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 Cohort 1; Three (3) Healthy volunteers, each receiving a single oral dose (50mg) of GNS561 tablets and capsules, after a high fat meal and with a wash-out period of seven days.	Drug: GNS561 oral tablets and capsules; Two formulations and Two dosage will be compared
Experimental: Part 1 Cohort 2; Six (6) healthy volunteers, each receiving a single oral dose (200mg) of GNS561 tablets and capsules, after a high fat meal and with a wash-out period of fourteen days.	Drug: GNS561 oral tablets and capsules; Two formulations and Two dosage will be compared
Experimental: Part 2; Nine (9) healthy volunteers, each receiving a single oral dose (200mg) of GNS561 tablets or capsules (according results of Part 1), in fed condition then in fasting condition, after a wash-out period of fourteen days. Nine (9) other healthy volunteers, each receiving a single oral dose (200mg) of GNS561 tablets or capsules (according results of Part 1), in fasting condition then in fed condition, after a wash-out period of fourteen days.	Drug: GNS561 oral tablets and capsules; Two formulations and Two dosage will be compared

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Plasma Concentration (Cmax)	blood samples at different time from GNS561 administration	Day 1, Day 2, Day 3, Day 4 and Day 7

Collaborators and Investigators

• Sponsor: Genoscience Pharma

Study record dates

Study Major Dates

• Study Start (Anticipated): May 2, 2022
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: GNS561-CL-I-Q-0321

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No