A Study of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy Volunteers

NCT01708616 | Completed Phase 1

• 2 other identifiers: BP283182012-003231-31
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, randomized, double-blind, two-period crossover study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of the combination of multiple doses of RO5285119 with a single dose of risperidone in healthy volunteers. Subjects will be randomized to one of 4 treatment sequences of two periods to receive multiple doses of RO5285119 plus a single dose of risperidone or risperidone placebo or multiple doses of RO5285119 placebo plus a single dose of risperidone or risperidone placebo, with a washout period of approximately 3 weeks between treatment periods. Anticipated time on study is up to 12 weeks (from screening through study completion).

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Maximum plasma concentration (Cmax)

  Pre-dose to 24 hours post-dose

• Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Area under the concentration-time curve (AUC)

  Pre-dose to 24 hours post-dose

Secondary Outcomes (5)

• Safety: Incidence of adverse events

  approximately 12 weeks

• Pharmacodynamic markers for risperidone: Prolactin levels

  Pre-dose to 6 hours post-dose

• Pharmacodynamic assessments for risperidone: Level of sedation

  Pre-dose to 24 hours post-dose

• Pharmacokinetics of RO5285119 in combination with single dose risperidone: Maximum plasma concentration (Cmax)

  Day 1 to Day 18

• Pharmacokinetics of RO5285119 in combination with single dose risperidone: Area under the concentration-time curve (AUC)

  Day1 to Day 18

Study Arms (4)

Placebo + risperidone

PLACEBO COMPARATOR

Drug: RO5285119 placebo; Drug: risperidone

Placebo +placebo

PLACEBO COMPARATOR

Drug: RO5285119 placebo; Drug: risperidone placebo

RO5285119 + placebo

ACTIVE COMPARATOR

Drug: RO5285119; Drug: risperidone placebo

RO5285119 + risperidone

EXPERIMENTAL

Drug: RO5285119; Drug: risperidone

Interventions

RO5285119 DRUG

multiple doses

RO5285119 + placebo; RO5285119 + risperidone

RO5285119 placebo DRUG

multiple doses

Placebo + risperidone; Placebo +placebo

risperidone DRUG

single dose

Placebo + risperidone; RO5285119 + risperidone

risperidone placebo DRUG

single dose

Placebo +placebo; RO5285119 + placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female adults, 18 - 50 years of age inclusive Healthy status is defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis
• Body mass index (BMI) 18 to 30 kg/m2 inclusive
• Women have to be postmenopausal or surgically sterile
• Male subjects must use a barrier method of contraception for the duration of the study and for 3 months after last dosing

You may not qualify if:

• Suspicion of regular consumption of drug of abuse, or history of drug or alcohol abuse
• Positive for hepatitis B, hepatitis C or HIV infection
• History of clinically significant hypersensitivity or allergic reactions
• Disorders of the central nervous system, including psychiatric disorders, behavioural disturbances, cerebrovascular events, depression, bipolar disorder, migraine, Parkinson
• Regular smoker (\>5 cigarettes, \>3 pipe-fulls, \>3 cigars per day)
• Administration of an investigational drug or device within 3 months prior to first dosing
• Hypersensitivity to risperidone or any of its excipients
• Any other known contraindications to risperidone as stated in the SmPC

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Rennes, 35042, France

Location

MeSH Terms

Interventions

Risperidone

Intervention Hierarchy (Ancestors)

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

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2012
• First Posted: October 17, 2012
• Study Start: November 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

FR (1)