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

NCT ID: NCT01873508

Last Updated: 2015-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2013-08-31

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.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Fast release MR capsule

Group Type: EXPERIMENTAL

RO4917523

Intervention Type: DRUG

Fast release MR capsule, single dose

Slow release MR capsule

Group Type: EXPERIMENTAL

RO4917523

Intervention Type: DRUG

Slow release MR capsule, single dose

Target release MR capsule

Group Type: EXPERIMENTAL

RO4917523

Intervention Type: DRUG

Target release MR capsule, single dose

RO4917523

Intervention Type: DRUG

\[13C\]-labeled tracer dose i.v.

Interventions

RO4917523

Fast release MR capsule, single dose

Intervention Type: DRUG

RO4917523

Target release MR capsule, single dose

Intervention Type: DRUG

RO4917523

Slow release MR capsule, single dose

Intervention Type: DRUG

RO4917523

\[13C\]-labeled tracer dose i.v.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Marlton, New Jersey, United States

Countries

United States

Other Identifiers

2013-000502-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NP28738

Identifier Type: -

Identifier Source: org_study_id