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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: risperidone; Drug: RO5285119; Drug: RO5285119 placebo; Drug: risperidone placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01708616

2012-003231-31 (EudraCT Number)

BP28318

Details and patient eligibility

About

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).

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

24 participants in 4 patient groups, including a placebo group

Placebo + risperidone

Placebo Comparator group

Treatment:

Drug: RO5285119 placebo

Drug: risperidone

Placebo +placebo

Placebo Comparator group

Treatment:

Drug: RO5285119 placebo

Drug: risperidone placebo

RO5285119 + placebo

Active Comparator group

Treatment:

Drug: RO5285119

Drug: risperidone placebo

RO5285119 + risperidone

Experimental group

Treatment:

Drug: RO5285119

Drug: risperidone