KF2022#3-trial: Effect of Tea and Cola Beverage on Absorption of Risperidone Oral Solution

Psychosis Clinical Trial

— KF2022#3  

Official title:

KF2022#3-tutkimus: Teen ja Kolajuoman Vaikutus Risperidoni-oraaliliuoksen Imeytymiseen

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06218979
• Other study ID #: KF2022#3
• Status: Recruiting
• Phase: Phase 1
• Start date: December 4, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Helsinki University Central Hospital
• Contact: Janne T Backman, MD, PhD
• Phone: +35894711
• Email: janne.backman[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Food-drug Interaction
• Psychosis
• Psychotic Disorders

Intervention

Drug:
• Risperidone oral solution
See arm/group descriptions

Locations

Country	Name	City	State
Finland	Department of Clinical Pharmacology	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration - time curve of risperidone		Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
Secondary	Peak plasma concentration for both risperidone and its metabolites		Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
Secondary	Half-life for both risperidone and its metabolites		Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
Secondary	Time to peak plasma concentration for both risperidone and its metabolites		Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
Secondary	Fractional areas under concentration-time curve (AUC) for both risperidone and its metabolites		Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
Secondary	Areas under concentration-time curve (AUC) for risperidone metabolites		Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone
Secondary	CYP2D6 activity biomarkers (solanidine and its metabolites)		Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone