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

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.

Study Overview

• Status: Recruiting
• Conditions: Psychosis; Food-drug Interaction
• Intervention / Treatment: Drug: Risperidone oral solution

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Janne T Backman, MD, PhD; Phone Number: +35894711; Email: janne.backman@hus.fi
• Study Contact Backup: Name: Laura Tervala; Phone Number: +35894711; Email: laura.tervala@hus.fi

Study Locations

• Finland
  • Helsinki, Finland
    • Recruiting
    • Department of Clinical Pharmacology
    • Contact: Janne Backman, MD, PhD; Phone Number: +35894711; Email: janne.backman@hus.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control phase; 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.	Drug: Risperidone oral solution; See arm/group descriptions; Other Names: Twinings English Breakfast tea; Pepsi Max beverage
Active Comparator: Tea phase; 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.	Drug: Risperidone oral solution; See arm/group descriptions; Other Names: Twinings English Breakfast tea; Pepsi Max beverage
Active Comparator: Cola beverage phase; 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.	Drug: Risperidone oral solution; See arm/group descriptions; Other Names: Twinings English Breakfast tea; Pepsi Max beverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: University of Helsinki
• Investigators: Principal Investigator: Janne Backman, MD, PhD, Professor, Head physician

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Estimated): January 23, 2024

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: KF2022#3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No