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

NCT05353894 | Unknown Phase 1 DMC

• 1 other identifier: GNS561-CL-I-Q-0321
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Maximum Plasma Concentration (Cmax)

  Day 1, Day 2, Day 3, Day 4 and Day 7

Study Arms (3)

Part 1 Cohort 1

EXPERIMENTAL

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

Part 1 Cohort 2

EXPERIMENTAL

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

Part 2

EXPERIMENTAL

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

Interventions

GNS561 oral tablets and capsules DRUG

Two formulations and Two dosage will be compared

Part 1 Cohort 1; Part 1 Cohort 2; Part 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Genoscience Pharma: lead

Study Sites (1)

Genoscience Pharma

Marseille, 13006, France

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 29, 2022
• Study Start: May 2, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)