Primary objective:- To evaluate the safety and tolerability profiles of three oral doses of Namisol® in a healthy elderly population Secondary objective:- To evaluate the relationship between the pharmacodynamic effects (using VAS-feeling high, TAP-…
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Brief title
Condition
- Other condition
Synonym
Health condition
NVT. De studiemedicatie wordt gegeven aan gezonde ouderen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Safety and tolerability profiles of three oral doses of Namisol®
Secondary outcome
1- The relationship between VAS-feeling high and the plasma concentrations of
THC and its active metabolites 11-OH-THC and THC-COOH in a healthy elderly
population at three different doses Namisol®
2- The relationship between TAP- alertness and the plasma concentrations of THC
and its active metabolites 11-OH-THC and THC-COOH in a healthy elderly
population at three different doses Namisol®
3- The relationship between Body Sway and the plasma concentrations of THC and
its active metabolites 11-OH-THC and THC-COOH in a healthy elderly population
at three different doses Namisol®
Background summary
The results of phase I Namisol® study, implicate that Namisol® may have a
favorable PK and PD characteristics and is safe to use in people. However, the
study included only young adults with a mean age of 21.4 years. Moreover, the
results of the study are not to translate well into elderly.
In general, there is a strong concern about the safety and tolerability of THC
in the elderly population. This is because, elderly persons in general have
higher risk of adverse drug reactions due to a combination of physiological
factors such as decreasing in lean body mass, the reduction of renal and
hepatic clearance, and medical comorbidity which can lead to polypharmacy and
drug-drug interactions. Therefore, it is very important to evaluate the safety
and tolerability profiles of different Namisol® doses in the elderly
population.
In the current study we will use the following Namisol® doses: 3 mg, 5 mg and
6,5 mg. The doses 5 mg and 6,5 mg had been used in phase I study. The dose 8
mg, will not be investigated in this study due to the high incidence of adverse
drug reactions in young adults (9/9 subjects).
Study objective
Primary objective:
- To evaluate the safety and tolerability profiles of three oral doses of
Namisol® in a healthy elderly population
Secondary objective:
- To evaluate the relationship between the pharmacodynamic effects (using
VAS-feeling high, TAP-alertness and body sway) and the plasma concentrations of
THC and its active metabolites 11-OH-THC and THC-COOH in a healthy elderly
population at three different doses Namisol®
Study design
A randomized, double-blind, placebo-controlled, cross-over, single-center trial
Intervention
Volunteers will be randomized to receive 3 doses Namisol® (3 mg, 5 mg, 6,5 mg)
and placebo during 4 seperatie occasions (visit 1 to 4).
Study burden and risks
The study participants are healthy elderly volunteers who will not benefit from
the participation in this clinical trial. They will visit the centre five
times: Visit 0: general screening. Visit 1-4: eligible subjects will be
admitted to the trial unit for 4,5 hours. Namisol® will be administrated and
blood sampling and test blocks will be undertaken. The total duration of the
screening period is 2 hours and the intervention period is 18 hours.
During the trial period, a total of 23 blood samples will be taken [Visit 0: 2
samples and visit 1 - 4: 8 samples for safety screening, 1 for genotyping of
cytochrome P450 enzymes and 16 for the plasma concentrations of THC, 11-OH-THC
and THC-COOH]. The total volume that will be taken is 166 ml.
To facilitate blood sampling on each intervention visit, an intravenous cannula
will be inserted, prior to drug administration. The total duration of the study
for each subject from screening until the end of study is 8 weeks.
Possible THC adverse events are: drowsiness, ataxia (loss of coordination),
euphoria, and dizziness.
Philips van Leijdenlaan 15
Nijmegen 6525 EX
NL
Philips van Leijdenlaan 15
Nijmegen 6525 EX
NL
Listed location countries
Age
Inclusion criteria
- Subject is a healthy old person as established by medical history, physical examination, electrocardiography, results of hematological and biochemical blood tests on screening.
- Age 65 years or older
- Body mass index (BMI) between 18.0 and 30 kg m-2
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
Exclusion criteria
- Regular cannabis user defined as: smoking one or more joints per week
- Documented history of sensitivity/idiosyncrasy to cannabis
- Relevant history or presence of severe pulmonary disorders [e.g. COPD GOLD III or IV], serious cardiovascular disorders [e.g. myocardial infarction < 6 months ago; atrial fibrillation; heart failure NYHA III or IV; severe heart valve disease, orthostatic hypotension defined as systolic drop of 20 mm Hg or diastolic drop of 10 mm Hg], seizures, migraine, psychiatric disorders [e.g. depression (based on documented history or GDS-30 on screening >= 10); mania; psychosis; dementia], cognitive impairment [based on documented history or MMSE on screening < 28, significant renal (GFR < 30 ml/min) or hepatic disorders [e.g. cancer, cirrhosis. ALT or AST >= twice the upper limit of normal], diabetes mellitus, coagulation disorders
- Inability to understand the nature and extent of the trial and the procedures required
- Current alcohol abuse or use of more than 2 alcoholic consumptions daily
- History of, or current drug abuse
- Using drugs that are inhibitors of CYP2C9, CYP2C19 and CYP3A4 (see appendix 13.3)
- Participation in a drug trial within 60 days prior to the first intervention day
- Donation of blood within 60 days prior to the first intervention day
- Known lactosis intolerance
- Using more than six units of (methyl)xanthine products per day (e.g. coffee, tea, cola, chocolate)
- Smoking more than ten cigarettes per day
- High fall-risk (based on Body Sway Test)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-001841-42-NL |
| CCMO | NL40591.091.12 |
| Other | Protocol wordt ingediend bij clinicaltrials.gov, identificatienummer nog onbekend |