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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01873508
First received: June 6, 2013
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This single-center, open label, randomized, 3-period cross-over study will compa re 3 modified-release formulations of RO4917523 in healthy volunteers. Subjects will be randomized to one of six sequences to receive single oral doses of RO491 7523 slow, target and fast release modified release (MR) capsules along with a r eference intravenous microdose with the target capsule. A washout period of at l east 21 days will occur between treatments.


Condition Intervention Phase
Healthy Volunteer
Drug: RO4917523
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics: Maximum concentration (Cmax) [ Time Frame: Pre-dose and up to 144 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose and up to 144 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics: Time to maximum plasma concentration (tmax) [ Time Frame: Pre-dose and up to 144 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Elimination half-life (t1/2) [ Time Frame: Pre-dose and up to 144 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Elimination rate constant: (kel) [ Time Frame: Pre-dose and up to 144 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Absolute bioavailability (F) [ Time Frame: Pre-dose and up to 144 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Total body clearance (CL) [ Time Frame: Pre-dose and up to 144 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Volume of distribution (Vd) [ Time Frame: Pre-dose and up to 144 hours post-dose ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 13 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: June 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fast release MR capsule Drug: RO4917523
Fast release MR capsule, single dose
Experimental: Slow release MR capsule Drug: RO4917523
Slow release MR capsule, single dose
Experimental: Target release MR capsule Drug: RO4917523
Target release MR capsule, single dose
Drug: RO4917523
[13C]-labeled tracer dose i.v.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01873508

Locations
Netherlands
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01873508     History of Changes
Other Study ID Numbers: NP28738, 2013-000502-28
Study First Received: June 6, 2013
Last Updated: August 26, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

ClinicalTrials.gov processed this record on September 22, 2014