A two part bioavailability study on synthetic THC containing chewing gum formulations in healthy male and female volunteers.

Recruiting

• Conditions: 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

• Registration Number: NL-OMON49009
• Lead Sponsor: Axim Biotechnologies B.V. .

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

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 <=30.0 kg/m2 at
Screening.
- Subject is in good health as judged by the Investigator and based on medical
history, physical examination, vital sign measurements, ECG, and laboratory
safety tests performed at Screening.

Please refer to the protocol for more inclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part 1: THC plasma concentration after single dose administration of sTHC<br /><br>chewing gum.<br /><br>Part 2: The pharmacokinetic parameter AUC0-inf will be used to evaluate the<br /><br>relative bioavailability.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Part 2:<br /><br>Pharmacokinetic parameters of THC and 11-OH-&Delta;9-THC in plasma after single dose<br /><br>administration of sTHC chewing gum and dronabinol capsules.<br /><br>Safety and tolerability parameters including (serious) adverse events ((s)AEs),<br /><br>clinical laboratory values, vital signs, physical examination, ECG, taste<br /><br>questionnaire and Bowdle VAS after single dose administration of sTHC chewing<br /><br>gum and dronabinol capsules.</p><br>