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

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ClinicalTrials.gov Identifier: NCT01708616
Recruitment Status : Completed
First Posted : October 17, 2012
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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).

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: RO5285119 Drug: RO5285119 placebo Drug: risperidone Drug: risperidone placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
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
Study Start Date : November 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Risperidone

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo + risperidone Drug: RO5285119 placebo
multiple doses

Drug: risperidone
single dose
Placebo Comparator: Placebo +placebo Drug: RO5285119 placebo
multiple doses

Drug: risperidone placebo
single dose
Active Comparator: RO5285119 + placebo Drug: RO5285119
multiple doses

Drug: risperidone placebo
single dose
Experimental: RO5285119 + risperidone Drug: RO5285119
multiple doses

Drug: risperidone
single dose


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708616


Locations
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France
Rennes, France, 35042
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01708616    
Other Study ID Numbers: BP28318
2012-003231-31 ( EudraCT Number )
First Posted: October 17, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents