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Completed

NCT Number: NCT01708616

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

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).

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rennes, 35042, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO5285119

Drug

multiple doses

RO5285119 placebo

Drug

multiple doses

Risperidone

Drug

single dose

risperidone placebo

Drug

single dose

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 17, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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