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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: RO4917523; Drug: RO4917523; Drug: RO4917523; Drug: RO4917523

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Marlton, New Jersey, United States, 08053

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fast release MR capsule	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.
Experimental: Slow release MR capsule	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.
Experimental: Target release MR capsule	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics: Area under the concentration-time curve (AUC)	Pre-dose and up to 144 hours post-dose
Pharmacokinetics: Maximum concentration (Cmax)	Pre-dose and up to 144 hours post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics: Time to maximum plasma concentration (tmax)	Pre-dose and up to 144 hours post-dose
Pharmacokinetics: Elimination half-life (t1/2)	Pre-dose and up to 144 hours post-dose
Pharmacokinetics: Elimination rate constant: (kel)	Pre-dose and up to 144 hours post-dose
Pharmacokinetics: Absolute bioavailability (F)	Pre-dose and up to 144 hours post-dose
Pharmacokinetics: Total body clearance (CL)	Pre-dose and up to 144 hours post-dose
Pharmacokinetics: Volume of distribution (Vd)	Pre-dose and up to 144 hours post-dose
Safety: Incidence of adverse events	approximately 13 weeks

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: June 6, 2013
• First Submitted That Met QC Criteria: June 6, 2013
• First Posted (Estimate): June 10, 2013

Study Record Updates

• Last Update Posted (Estimate): September 10, 2015
• Last Update Submitted That Met QC Criteria: September 9, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: NP28738; 2013-000502-28 (EudraCT Number)