## Protocol Section
### Identification Module
**NCT ID:** NCT06218979

**Acronym:** KF2022#3

**Brief Title:** 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

#### Organization Study ID Info
**ID:** KF2022#3
#### Organization
**Class:** OTHER
**Full Name:** Helsinki University Central Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-01-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-01-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-12-04

**Type:** ACTUAL

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2024-01-23
**Type:** ACTUAL
**Study First Submit Date:** 2023-12-04
**Study First Submit QC Date:** 2024-01-22
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Helsinki

#### Lead Sponsor

**Class:** OTHER

**Name:** Helsinki University Central Hospital

#### Responsible Party

**Investigator Affiliation:** Helsinki University Central Hospital

**Investigator Full Name:** Janne Backman

**Investigator Title:** Professor, head physician

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Psychosis

- Food-drug Interaction

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 12

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Drug: Risperidone oral solution

**Label:** Control phase

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Drug: Risperidone oral solution

**Label:** Tea phase

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** 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.

**Intervention Names:**

- Drug: Risperidone oral solution

**Label:** Cola beverage phase

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cola beverage phase

- Control phase

- Tea phase

**Description:** See arm/group descriptions

**Name:** Risperidone oral solution

**Other Names:**

- Twinings English Breakfast tea

- Pepsi Max beverage

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**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

#### Secondary Outcomes

**Measure:** 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

**Measure:** 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

**Measure:** 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

**Measure:** 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

**Measure:** 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

**Measure:** 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

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** janne.backman@hus.fi

**Name:** Janne T Backman, MD, PhD

**Phone:** +35894711

**Role:** CONTACT

**Contact 2:**

**Email:** laura.tervala@hus.fi

**Name:** Laura Tervala

**Phone:** +35894711

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Helsinki

**Contacts:**

***Contact 1:***

- **Email:** janne.backman@hus.fi

- **Name:** Janne Backman, MD, PhD

- **Phone:** +35894711

- **Role:** CONTACT

**Country:** Finland

**Facility:** Department of Clinical Pharmacology

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Professor, Head physician

**Name:** Janne Backman, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019967

- Term: Schizophrenia Spectrum and Other Psychotic Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: HIGH

- As Found: Psychosis

- ID: M15376

- Name: Schizophrenia

- Relevance: LOW

- As Found: Unknown

- ID: M21838

- Name: Schizophrenia Spectrum and Other Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011618

- Term: Psychotic Disorders

### Intervention Browse Module - Ancestors

- ID: D000012702

- Term: Serotonin Antagonists

- ID: D000018490

- Term: Serotonin Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000014150

- Term: Antipsychotic Agents

- ID: D000014149

- Term: Tranquilizing Agents

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000011619

- Term: Psychotropic Drugs

- ID: D000018492

- Term: Dopamine Antagonists

- ID: D000015259

- Term: Dopamine Agents

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: CaAg

- Name: Cardiotonic Agents

- Abbrev: HB

- Name: Herbal and Botanical

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M20999

- Name: Risperidone

- Relevance: HIGH

- As Found: Evening

- ID: M15512

- Name: Serotonin

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M16904

- Name: Antipsychotic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

- ID: M7473

- Name: Dopamine

- Relevance: LOW

- As Found: Unknown

- ID: M20596

- Name: Dopamine Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M17962

- Name: Dopamine Agents

- Relevance: LOW

- As Found: Unknown

- ID: T312

- Name: Tea

- Relevance: LOW

- As Found: Unknown

- ID: T120

- Name: Cola

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000018967

- Term: Risperidone

### Misc Info Module

- Version Holder: 2024-05-24
