PsychosisPhase 1KF2022#3NCT06218979
KF2022#3-trial: Effect of Tea and Cola Beverage on Absorption of Risperidone Oral Solution
A Phase 1 study testing Risperidone oral solution in people with Psychosis and Food-drug Interaction, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychosis, Food-drug Interaction
- What is being tested?
- Risperidone oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteFinland
- Study dates
- 8 Dec 2023to 14 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: KF2022#3-tutkimus: Teen Ja Kolajuoman Vaikutus Risperidoni-oraaliliuoksen Imeytymiseen
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.
- Conditions
- Psychosis, Food-drug Interaction
- Being tested
- Risperidone oral solution
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risperidone oral solutionDrug
Also called Twinings English Breakfast tea, Pepsi Max beverage
See arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Control phase | Placebo comparator | Study drug dose (1 mg risperidone) and 250 ml of water at 8:00 a.m., and 250 ml of water at 8:30 a.m. Receives: Drug: Risperidone oral solution |
| Tea phase | Active comparator | Study drug dose (1 mg risperidone) and 250 ml of tea at 8:00 a.m., and 250 ml of tea at 8:30 a.m. Receives: Drug: Risperidone oral solution |
| Cola beverage phase | Active comparator | Study drug dose (1 mg risperidone) and 250 ml cola drink at 8:00 a.m., and 250 ml cola beverage at 8:30 a.m. Receives: Drug: Risperidone oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration - time curve of risperidone
Measured: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
Secondary outcomes (6)
Peak plasma concentration for both risperidone and its metabolites
Measured: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
Half-life for both risperidone and its metabolites
Measured: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
Time to peak plasma concentration for both risperidone and its metabolites
Measured: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
Fractional areas under concentration-time curve (AUC) for both risperidone and its metabolites
Measured: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
Areas under concentration-time curve (AUC) for risperidone metabolites
Measured: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
CYP2D6 activity biomarkers (solanidine and its metabolites)
Measured: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start8 Dec 2023
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Principal investigator, Janne Backman, Helsinki University Central Hospital
- Investigators
- Janne Backman, MD, PhD, Principal investigator, Professor, Head physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218979
- Sponsor's protocol ID
- KF2022#3
- Acronym
- KF2022#3
- Status last verified
- Nov 2024
- First submitted
- 4 Dec 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KF2022#3-tutkimus: Teen Ja Kolajuoman Vaikutus Risperidoni-oraaliliuoksen Imeytymiseen
- ClinicalTrials.gov ID
- NCT06218979
- Acronym / sponsor ID
- KF2022#3 / KF2022#3
- Conditions
- Psychosis, Food-drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control phase | Placebo comparator | Drug: Risperidone oral solutionStudy drug dose (1 mg risperidone) and 250 ml of water at 8:00 a.m., and 250 ml of water at 8:30 a.m. |
| Tea phase | Active comparator | Drug: Risperidone oral solutionStudy drug dose (1 mg risperidone) and 250 ml of tea at 8:00 a.m., and 250 ml of tea at 8:30 a.m. |
| Cola beverage phase | Active comparator | Drug: Risperidone oral solutionStudy drug dose (1 mg risperidone) and 250 ml cola drink at 8:00 a.m., and 250 ml cola beverage at 8:30 a.m. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Written informed consent
- Age 18-45
- Healthy
- Systolic blood pressure ≥110 mmHg
- Heart rate ≥ 50/min
Key exclusion criteria (10 listed)
- Significant disease
- Mood disorder or suicidality
- Smoking
- Using oral contraception pills or other regular medication
- Pregnancy (current or planned) or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risperidone oral solutionAlso: Twinings English Breakfast tea, Pepsi Max beverageSee arm/group descriptions | Drug | Cola beverage phase, Control phase, Tea phase |
Primary outcome
Area under the plasma concentration - time curve of risperidone
Time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
6 secondary outcomes
Peak plasma concentration for both risperidone and its metabolites
Time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
Half-life for both risperidone and its metabolites
Time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
Time to peak plasma concentration for both risperidone and its metabolites
Time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
Fractional areas under concentration-time curve (AUC) for both risperidone and its metabolites
Time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
Areas under concentration-time curve (AUC) for risperidone metabolites
Time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
CYP2D6 activity biomarkers (solanidine and its metabolites)
Time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janne Backman, MD, PhD principal investigator
Professor, Head physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Risperidone oral solution in people with Psychosis and Food-drug Interaction, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration - time curve of risperidone (time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.