Clinical trial NCT06218979: KF2022#3-trial: Effect of Tea and Cola Beverage on Absorption of Risperidone Oral Solution
Official title: KF2022#3-tutkimus: Teen Ja Kolajuoman Vaikutus Risperidoni-oraaliliuoksen Imeytymiseen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psychosis
Food-drug Interaction
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
First posted: 2024-01-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Risperidone is widely used in the treatment of schizophrenia, bipolar disorder, and aggression associated with moderate or severe Alzheimer's dementia. In vitro studies have shown that constituents of tea and cola beverages can result in insoluble complex formation with risperidone, potentially reducing risperidone oral absorption. The purpose of this study is to investigate the effect of tea and cola beverage on the pharmacokinetics of risperidone oral solution.

In an open three-phase, randomized, crossover study with 12 healthy volunteers, the subjects will receive a 1 mg dose of risperidone oral solution with either water, tea or cola beverage. Blood samples will be collected and risperidone's pharmacokinetics will be monitored up to 48 hours postdose. Primary endpoint is area under the plasma concentration-time curve of risperidone.

Recruitment starting date is December 4, 2023.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age 18-45
* Healthy
* Systolic blood pressure ≥110 mmHg
* Heart rate ≥ 50/min
* Normal ECG
* Accepted results from laboratory tests (blood haemoglobin, basic blood count and blood platelets, alanine aminotransferase, alkaline phosphatase, glutamyl transferase, creatinine, plasma potassium and sodium). Negative pregnancy test result (serum human chorionic gonadotropin) for women.

Exclusion Criteria:

* Significant disease
* Mood disorder or suicidality
* Smoking
* Using oral contraception pills or other regular medication
* Pregnancy (current or planned) or nursing
* Participation in any other studies involving investigational or marketed drug products within three months prior to the entry into this study
* Donation of blood within three months prior to the entry into this study
* Significant overweight / small or hard-to-find veins
* BMI \< 18.5 kg/m2
* Insufficient Finnish language skills

Primary outcomes:
measure: Area under the plasma concentration - time curve of risperidone
timeFrame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
Secondary outcomes:
measure: Peak plasma concentration for both risperidone and its metabolites
timeFrame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
measure: Half-life for both risperidone and its metabolites
timeFrame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
measure: Time to peak plasma concentration for both risperidone and its metabolites
timeFrame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
measure: Fractional areas under concentration-time curve (AUC) for both risperidone and its metabolites
timeFrame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
measure: Areas under concentration-time curve (AUC) for risperidone metabolites
timeFrame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
measure: CYP2D6 activity biomarkers (solanidine and its metabolites)
timeFrame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Department of Clinical Pharmacology
Study officials:
affiliation: Professor, Head physician
name: Janne Backman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: