CompletedNCT01708616Updated Nov 2, 2016

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

A Phase 1 interventional study of RO5285119 and RO5285119 placebo in Healthy Volunteer, sponsored by Hoffmann-La Roche. Completed at 1 site in France. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Hoffmann-La Roche · Phase 1 and Interventional

Phase: Phase 1
Study type: Interventional
Enrollment: 24
Ages: 18 Years to 50 Years
Sex: All

Study 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 studied

Healthy Volunteer

In context

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Phase: Phase 1
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 24 participants (actual)

Study arms

Placebo comparator
Placebo + risperidone
Drug: RO5285119 placebo · Drug: risperidone
Placebo comparator
Placebo +placebo
Drug: RO5285119 placebo · Drug: risperidone placebo
Active comparator
RO5285119 + placebo
Drug: RO5285119 · Drug: risperidone placebo
Experimental
RO5285119 + risperidone
Drug: RO5285119 · Drug: risperidone

Interventions

DrugRO5285119
multiple doses
DrugRO5285119 placebo
multiple doses
Drugrisperidone
single dose
Drugrisperidone placebo
single dose

What researchers measure

Primary outcomes

Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Maximum plasma concentration (Cmax)
Time frame: 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)
Time frame: Pre-dose to 24 hours post-dose

Secondary outcomes

Safety: Incidence of adverse events
Time frame: approximately 12 weeks
Pharmacodynamic markers for risperidone: Prolactin levels
Time frame: Pre-dose to 6 hours post-dose
Pharmacodynamic assessments for risperidone: Level of sedation
Time frame: Pre-dose to 24 hours post-dose
Pharmacokinetics of RO5285119 in combination with single dose risperidone: Maximum plasma concentration (Cmax)
Time frame: Day 1 to Day 18
Pharmacokinetics of RO5285119 in combination with single dose risperidone: Area under the concentration-time curve (AUC)
Time frame: Day1 to Day 18

Study locations

1 site

Rennes, 35042, France

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01708616
Lead sponsor: Hoffmann-La Roche
Responsible party: Sponsor
First posted: Oct 17, 2012
Start date: Nov 2012
Primary completion: Feb 2013
Completion: Feb 2013
Last update: Nov 2, 2016

Study contacts

Clinical Trials

study director · Hoffmann-La Roche

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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