Explorative, randomized, double-blind, placebo-controlled, 3-way cross-over study to assess the effects of oral cannabidiol 160 and 1500 mg in healthy male subjects on evoked pain tests and CNS using PainCart and NeuroCart test batteries.

Phase 2

Withdrawn

• Conditions: Pain and CNS assessments; Evaluation PD effects

• Registration Number: NL-OMON49760
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

1. Signed informed consent prior to any study-mandated procedure.
2. Healthy male subjects, 18 up and to 55 years of age, inclusive at screening.
3. Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and
with a minimum weight of 50 kg.
4. All subjects must practice effective contraception during the study and be
willing and able to continue contraception for at least 90 days after their
last dose of study treatment.
5. Has the ability to communicate well with the investigator in the Dutch
language and willing to comply with the study restrictions.

Exclusion Criteria

1. Evidence of any active or chronic disease or condition that could interfere
with, or for which the treatment of might interfere with, the conduct of the
study, or that would pose an unacceptable risk to the subject in the opinion of
the investigator (following a detailed medical history, physical examination,
vital signs (systolic and diastolic blood pressure, pulse rate, body
temperature) and 12-lead electrocardiogram (ECG)). Minor deviations from the
normal range may be accepted, if judged by the investigator to have no clinical
relevance.
2. Clinically significant abnormalities, as judged by the investigator, in
laboratory test results (including hepatic and renal panels, complete blood
count, chemistry panel and urinalysis). In the case of uncertain or
questionable results, tests performed during screening may be repeated before
randomization to confirm eligibility or judged to be clinically irrelevant for
healthy subjects.
3. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab),
or human immunodeficiency virus antibody (HIV Ab) at screening.
4. Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and
diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg at
screening.
5. Abnormal relevant findings in the resting ECG at screening.
6. Participation in an investigational drug or device study (last dosing of
previous study was within 90 days prior to first dosing of this study).
7. History of abuse of addictive substances (alcohol, illegal substances) or
current use of more than 21 units alcohol per week, drug abuse, or regular user
of sedatives, hypnotics, tranquilizers, or any other addictive agent
8. Positive test for drugs of abuse at screening.
9. Alcohol will not be allowed from at least 24 hours before screening or
dosing.
10. Smoker of more than 10 cigarettes per day prior to screening or who use
tobacco products equivalent to more than 10 cigarettes per day and unable to
abstain from smoking whilst in the unit.
11. Excessive caffeine consumption (more than eight cups of coffee or
equivalent per day
12. Any confirmed significant allergic reactions (urticaria or anaphylaxis)
against any drug, multiple drug allergies (non-active hay fever is acceptable).
13. Loss or donation of blood over 500 mL within three months prior to
screening or intention to donate blood or blood products during the study.
14. Any known factor, condition, or disease that might interfere with treatment
compliance, study conduct or interpretation of the results such as drug or
alcohol dependence or psychiatric disease.
15. Any current, clinically significant, known medical condition in particular
any existing conditions that would affect sensitivity to cold (such as
atherosclerosis, Raynaud*s disease, urticaria, hypothyroidism) or pain (disease
that causes pain, hypesthesia, hyperalgesia, allodynia, paresthesia,
neuropathy, etc.).
16. Subjects indicating pain tests intolerable at screening or achieving
tolerance at >80% of maximum input intensity for the cold, pressure and
electrical tests.
17. Subject indicating intolerable pain after capsaicin administration at
screening.
18. History or presence of post-inflammatory hyperpigmentation.
19. Dark skin (Fitzpatrick skin type IV, V or VI), widespread acne, freckles

Study & Design

• Study Type: Interventional
• Study Design: Not specified