treatment of chemotherapy-induced nausea and vomiting (CINV) in patients who have failed to respond adequately to conventional antiemetic treatments. chemotherapy-induced nausea and vomiting
Conditions
Interventions
Synthetic Dronabinol
Marinol
Sponsors
Axim Biotechnologies B.V. .
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Subject is willing to give written informed consent. - Subject is a healthy male or female between 18 and 55 years of age, inclusive, at Screening. - A body mass index (BMI) in the range of >=18.0 kg/m2 and
Exclusion criteria
Exclusion criteria: - Women who are pregnant or nursing, or planning to do so soon. - Subject is mentally or legally incapacitated, has significant emotional problems at the time of Screening or is expected to get significant emotional problems during the conduct of the study or has a history of clinically significant psychiatric disorder within the last 5 years. - Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases. Subjects with a history of cholecystectomy, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma may be enrolled in the study at the discretion of the investigator. Please refer to the protocol for more exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: THC plasma concentration after single dose administration of sTHC chewing gum. Part 2: The pharmacokinetic parameter AUC0-inf will be used to evaluate the relative bioavailability. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 2: Pharmacokinetic parameters of THC and 11-OH-Δ9-THC in plasma after single dose administration of sTHC chewing gum and dronabinol capsules. Safety and tolerability parameters including (serious) adverse events ((s)AEs), clinical laboratory values, vital signs, physical examination, ECG, taste questionnaire and Bowdle VAS after single dose administration of sTHC chewing gum and dronabinol capsules. | — |
Countries
Netherlands
Outcome results
None listed