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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05353894
Other study ID # GNS561-CL-I-Q-0321
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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