Clinical Trial on Pharmacokinetic and Tolerability of AP701

CannaXan

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetic; Tolerability; Safety

Treatments: Drug: AP701

Study type: Interventional

Funder types: Industry

Identifiers

NCT04708795

SELECT

Details and patient eligibility

About

This study aims to investigate the uptake of AP701, a preparation from cannabis flowers, into the bloodstream after in single administration in healthy volunteers.

Full description

Pharmacokinetic parameters and tolerability of AP701 is studied over 30 hours after single dose administration in healthy volunteers in a prospective and open-label manner at a single study center.

Enrollment: 15 patients

Sex: Male

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Signed and dated informed consent form
2. Male in the age of 35 - 60 year at study start
3. Body mass index of 18 to 30 kg/m2
4. Non-smoker, no use of any Tabaco products
5. Good general health status (Karnofsky Score = 100)
6. Current ECG without abnormal findings (i.a. QTcF < 450 ms)
7. Physical examination, medical history without exclusionary findings
8. Pulse rate between 50 and 90 bpm
9. Blood pressure between systolic 90 - 140 mmHg, diastolic 50 - 90 mmHg
10. Lab values for liver function (ALT, AST, AP, Bilirubin total) within normal ranges
11. Lab values for renal function (S-Creatinine, eGFR) within normal range
12. Negative test result on HIV I, HIV II, hepatitis B cell surface antigen, hepatitis C antibody
13. Negative test result of urine screening for Cannabis, alcohol, and substance abuse

Exclusion criteria

1. Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
2. Use of Cannabis products within the last 8 weeks
3. Use of opioids
4. Former or present dependency (e.g. to alcohol, medicinal products, drugs)
5. Participation in another clinical trial within the last four weeks prior to study inclusion
6. Present, former, or family history of mental illnesses such as severe de pression, psychosis, bipolar disorder, mania, obsessive compulsive disorder, and anxiety disorder
7. Acute severe somatic disease (e.g. gastrointestinal diseases, influenza)
8. Body temperature ≥ 38 °C
9. Present cardiovascular, respiratory, diabetic, or cancer disease
10. Hepatitis or other liver and renal disease
11. Other diseases or conditions that do not allow the participant to assess the nature and scope, and possible consequences of participating in this clinical trial
12. Indications that the participant is unlikely to comply with the study protocol (e.g. lack of cooperation)
13. Taking any pharmaceutical products (including any medication interacting with metabolism of THC, e.g. St. John's wort)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Verum

Experimental group

Description:

AP701 single dose oromucosal application

Treatment:

Drug: AP701