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

Healthy Volunteer Clinical Trial

Official title:

A Single-center, Randomized, Double-blind, Two-period Crossover Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01708616
• Other study ID #: BP28318
• Secondary ID: 2012-003231-31
• Status: Completed
• Phase: Phase 1
• First received: October 15, 2012
• Last updated: November 1, 2016
• Start date: November 2012
• Est. completion date: February 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence nationale de sécurité du médicament et des produits de santé (ANSM)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO5285119
multiple doses
• RO5285119 placebo
multiple doses
• risperidone
single dose
• risperidone placebo
single dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Maximum plasma concentration (Cmax)		Pre-dose to 24 hours post-dose	No
Primary	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	No
Secondary	Safety: Incidence of adverse events		approximately 12 weeks	No
Secondary	Pharmacodynamic markers for risperidone: Prolactin levels		Pre-dose to 6 hours post-dose	No
Secondary	Pharmacodynamic assessments for risperidone: Level of sedation		Pre-dose to 24 hours post-dose	No
Secondary	Pharmacokinetics of RO5285119 in combination with single dose risperidone: Maximum plasma concentration (Cmax)		Day 1 to Day 18	No
Secondary	Pharmacokinetics of RO5285119 in combination with single dose risperidone: Area under the concentration-time curve (AUC)		Day1 to Day 18	No