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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GNS561 oral tablets and capsules | Drug | Two formulations and Two dosage will be compared |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genoscience Pharma | Marseille | 13006 | France |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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