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

NCT06218979 | Completed Phase 1

• 1 other identifier: KF2022#3
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychosis; Food-drug Interaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (3)

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.

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.

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.

Drug: Risperidone oral solution

Interventions

Risperidone oral solution DRUG

See arm/group descriptions

Also known as: Twinings English Breakfast tea, Pepsi Max beverage

Cola beverage phase; Control phase; Tea phase

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• University of Helsinki: collaborator

Study Sites (1)

Department of Clinical Pharmacology

Helsinki, Finland

Location

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janne Backman, MD, PhD

  Professor, Head physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, head physician

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: January 23, 2024
• Study Start: December 8, 2023
• Primary Completion: March 14, 2024
• Study Completion: March 14, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)