Clinical trial NCT05353894: Effect of Food and Formulation on the Pharmacokinetics, Safety, and Tolerability of GNS561 After One Single Dose (50 and 200mg) in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Primary Liver Cancer
Lead sponsor: Genoscience Pharma
Sponsor class: INDUSTRY
First posted: 2022-04-29
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: from first administration until 29 days
measure: Maximum Plasma Concentration (Cmax)
timeFrame: Day 1, Day 2, Day 3, Day 4 and Day 7
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: Day 1, Day 2, Day 3, Day 4 and Day 7
Other outcomes:
Locations:
city: Marseille
country: France
facility: Genoscience Pharma
Study officials:
References: