Study to assess the effects of oral cannabidiol in healthy male subjects on CNS using the NeuroCart test battery and TMS.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre for Human Drug Research

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male

Therapeutic area

Not possible to specify

Trial duration

20 Nov 2023 → 14 Mar 2024

Decision date (initial)

2023-11-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy, Pharmacodynamic

• To assess effects of a single oral dose of 30 and 700 mg cannabidiol compared to placebo on a specific set of CNS tasks as measured by the NeuroCart
• To assess effects of a single oral dose of 30 and 700 mg cannabidiol compared to placebo on excitability with single and paired pulse TMS-EMG
• To assess effects of a single oral dose of 30 and 700 mg cannabidiol compared to placebo on excitability with single and paired pulse TMS-EEG

Secondary objectives 2

1. • To assess pharmacokinetics (PK) of a single oral dose of 30 and 700 mg cannabidiol in healthy subjects in the first 8 hours after administration.
2. • To assess safety and tolerability of a single oral dose of 30 and 700 mg cannabidiol.

Conditions and MedDRA coding

Neurological assessments

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

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 5

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. History or presence of conditions which, in the judgment of the investigator, might increase the risk of performing TMS, including but not limited to epilepsy or febrile seizures, intracranial mass lesion, hydrocephalus, clinically significant head injury or trauma, metal objects in the brain or skull, cochlear implant or a deep brain stimulation device.
4. Any condition that could interfere with the quality or ability to perform TMS, such as an abnormal sleeping pattern (e.g., working night shifts), dreadlocks or hairpieces that cannot be removed or a rMT of more than 75% of the maximum stimulator output as measured using TMS-EMG during screening.
5. Female subjects are excluded because the menstrual cycle can influence TMS-EMG and TMS-EEG measures.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 9

1. Saccadic eye movements
2. Smooth pursuit eye movements
3. Adaptive tracking
4. N-Back (working memory load)
5. Visual Analog Scales (VAS) Bond and Lader; Bowdle
6. Visual Verbal Learning Test (VVLT) memory testing
7. Change from baseline in MEP
8. Change from baseline TMS evoked potential (TEP) measured using single pulse and paired pulse TMS at ISIs 2, 15 and 100 ms
9. Body Sway

Secondary endpoints 4

1. PK parameters of cannabidiol by non-compartmental analysis of the plasma concentration-time data
2. Treatment-emergent (serious) adverse events ((S)AEs) throughout the study at every study visit
3. Concomitant medication throughout the study at every study visit
4. Vital signs (Pulse Rate (bpm), Systolic blood pressure (mmHg), Diastolic blood pressure (mmHg)) as per assessment schedule

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre for Human Drug Research

Sponsor organisation

Centre for Human Drug Research

Address

Zernikedreef 8

City

Leiden

Postcode

2333 CL

Country

Netherlands

Scientific contact point

Organisation

Centre for Human Drug Research

Contact name

PI

Public contact point

Organisation

Centre for Human Drug Research

Contact name

PI

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

2 submissions — initial application plus substantial / non-substantial modifications