- To establish the pharmacokinetic profiles of saliva and plasma concentration of caffeine after a caffeinated beverage (two cups of espresso coffee) containing approximately 135 mg caffeine in total or one capsule containing 200 mg caffeine in…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
N/A
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Descriptive statistics of PK in blood and saliva and PK modelling.
Secondary outcome
N/A
Background summary
Despite caffeine*s frequent use in by children and adolescents, very little is
known about the relationship between the time-course of its effects related to
blood levels in this age group. Recently, a study was performed in healthy
adolescents in whom acute effects of a caffeinated beverage containing
approximately 135 mg caffeine were measured non-invasively using the NeuroCart
test battery (CHDR0918, data on file). As blood sampling is undesirable in
minors in the setting of a non-therapeutic study, saliva samples were collected
to measure caffeine concentration. Statistically significant caffeine effects
were found and saliva samples were analyzed successfully using a validated
high-performance liquid chromatography method. However, plasma caffeine levels
need to be estimated for population PK/PD analysis of the obtained data. By
combining saliva caffeine data with pharmacokinetic data in plasma, a PK model
could be build built that provides us with estimated plasma drug levels in
adolescents needed for population PK/PD analysis. As published data in adults
were pooled and therefore not readily available for use, a study in healthy
volunteers is needed in which both plasma and saliva samples will be obtained
prior and post administration of caffeine. As caffeine saliva PK may be
complicated by pH partitioning, the possible effect of saliva pH and/or flow on
caffeine saliva concentration will be investigated. In addition, caffeine will
be administered via a beverage and a capsule, on separate occasions. Any
differences will be observed to investigate the extent of oral
contamination/residue after drinking a caffeinated beverage.
Study objective
- To establish the pharmacokinetic profiles of saliva and plasma concentration
of caffeine after a caffeinated beverage (two cups of espresso coffee)
containing approximately 135 mg caffeine in total or one capsule containing 200
mg caffeine in healthy adult volunteers.
- To investigate whether there is a relationship between saliva- and plasma
levels of caffeine, and if present, to describe this relationship.
- To determine the effect of saliva pH and/or flow on saliva caffeine
concentration.
Study design
Randomized open-label cross-over study.
Intervention
Caffeinated beverage containing approximately 135 mg caffeine or capsule
containing 200 mg caffeine.
Study burden and risks
Caffeine has few unwanted side effects and is safe. As only a single relatively
low dose of caffeine will be administered per occasion, we do not expect that
these side effects occur, with exception of changes in heart rate and blood
pressure and short-term increased diuresis.
Zernikedreef 10
2333 CL Leiden
NL
Zernikedreef 10
2333 CL Leiden
NL
Listed location countries
Age
Inclusion criteria
- Subject must be 18-35 years of age (inclusive)
- Subject has a Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive) and body weight between 50 kg and 90 kg (inclusive);
- Subject is able to read and understand the written consent form, complete study-related procedures, and communicate with the study staff;
- Subject is willing to comply with study restrictions.
Exclusion criteria
- Clinically relevant abnormal history of physical and mental health as determined by medical history taking and physical examinations obtained during the screening visit (as judged by the investigator);
- Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings at screening (as judged by the investigator);
- Positive test for hepatitis B, C or HIV at screening;
- Positive urinary pregnancy test (females only) at screening;
- History of alcoholism or substance abuse within three years prior to screening;
- Male subjects habitually using more than 21 units of alcohol per week and female subjects using more than 14 units of alcohol per week;
- Positive urine drug screen at screening;
- Subject uses more than 5 units of xanthine-containing food products or drinks (including but not limited to coffee, tea, Red Bull, chocolate) daily;
- Subject is a smoker (> 5 cigarettes per day) or has used nicotine/nicotine-containing products within 3 months prior to screening;
- Subject is unable to refrain from the use of disallowed concomitant medication, dietary supplements or food products from one week prior to the first caffeine administration until the end of the last occasion;
- Subject is unable to refrain from food and drinks containing a xanthine (e.g. chocolate, cola, energy drinks, coffee or tea) from from 3 days prior to until the end of the study days;
- Participation in an investigational drug study within 90 days prior to the first dose and/or participation in more than 4 clinical trials in the last year;
- Donation or loss of blood (> 500 mL) within 3 months prior to screening.
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL40371.058.12 |