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A Study of Three Modified-Release Formulations of RO4917523 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01873508
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : September 10, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE June 6, 2013
First Posted Date  ICMJE June 10, 2013
Last Update Posted Date September 10, 2015
Study Start Date  ICMJE June 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose and up to 144 hours post-dose ]
  • Pharmacokinetics: Maximum concentration (Cmax) [ Time Frame: Pre-dose and up to 144 hours post-dose ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2013)
  • Pharmacokinetics: Maximum concentration (Cmax) [ Time Frame: Pre-dose and up to 144 hours post-dose ]
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose and up to 144 hours post-dose ]
Change History Complete list of historical versions of study NCT01873508 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2013)
  • Pharmacokinetics: Time to maximum plasma concentration (tmax) [ Time Frame: Pre-dose and up to 144 hours post-dose ]
  • Pharmacokinetics: Elimination half-life (t1/2) [ Time Frame: Pre-dose and up to 144 hours post-dose ]
  • Pharmacokinetics: Elimination rate constant: (kel) [ Time Frame: Pre-dose and up to 144 hours post-dose ]
  • Pharmacokinetics: Absolute bioavailability (F) [ Time Frame: Pre-dose and up to 144 hours post-dose ]
  • Pharmacokinetics: Total body clearance (CL) [ Time Frame: Pre-dose and up to 144 hours post-dose ]
  • Pharmacokinetics: Volume of distribution (Vd) [ Time Frame: Pre-dose and up to 144 hours post-dose ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 13 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Three Modified-Release Formulations of RO4917523 in Healthy Volunteers
Official Title  ICMJE A Single-center, Open Label, Randomized Cross-over Study to Compare 3 Modified-release Formulations With Different Release Profiles of RO4917523 Along With a Reference Intravenous Microdose Infusion
Brief Summary This single-center, open label, randomized, 3-period cross-over study will compare 3 modified-release formulations of RO4917523 in healthy volunteers. Subjects will be randomized to one of six sequences to receive single oral doses of RO4917523 slow, target and fast release modified release (MR) capsules along with a reference intravenous microdose with the target capsule. A washout period of at least 21 days will occur between treatments.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy Volunteer
Intervention  ICMJE
  • Drug: RO4917523
    Fast release MR capsule, single dose
  • Drug: RO4917523
    Target release MR capsule, single dose
  • Drug: RO4917523
    Slow release MR capsule, single dose
  • Drug: RO4917523
    [13C]-labeled tracer dose i.v.
Study Arms  ICMJE
  • Experimental: Fast release MR capsule
    Intervention: Drug: RO4917523
  • Experimental: Slow release MR capsule
    Intervention: Drug: RO4917523
  • Experimental: Target release MR capsule
    Interventions:
    • Drug: RO4917523
    • Drug: RO4917523
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2013)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and female volunteers, 18 - 55 years of age inclusive Healthy status will be defined by absence in evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
  • Body mass index (BMI) of 18 to 30 kg/m2, inclusive, and body weight of at least 50 kg
  • Females of child-bearing potential must agree to use effective contraception as defined by protocol
  • Non-smoker for at least 90 days prior to dosing on Day 1

Exclusion Criteria:

  • History or presence of a clinically significant psychiatric condition as defined by protocol
  • Participation in an clinical study with an investigational drug within 60 days or 5 times the half-life (whichever is longer) preceding first administration of study drug. Participation in more than 3 other drug studies within 10 months preceding first administration of study drug.
  • Clinically significant disease or disorder
  • Personal or family history of long QT syndrome or sudden death
  • Any suspicion or history of alcohol and/or other substance abuse or dependence in the last 6 months
  • Subject likely to need concomitant medication during the study (including for dental conditions), except for hormonal contraception or HRT
  • Pregnant or lactating women, or women who intend to become pregnant during the course of the study
  • Positive for hepatitis B, hepatitis C or HIV infection
  • Any confirmed significant allergic reactions against any drug, or multiple allergies
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Netherlands
 
Administrative Information
NCT Number  ICMJE NCT01873508
Other Study ID Numbers  ICMJE NP28738
2013-000502-28 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP