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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: RO4917523

• Registration Number: NCT01873508
• Lead Sponsor: Hoffmann-La Roche

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 available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-06
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-10
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-09
• Last Update Posted: 2015-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Target release MR capsule	RO4917523	-
Slow release MR capsule	RO4917523	-
Fast release MR capsule	RO4917523	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Pharmacokinetics: Time to maximum plasma concentration (tmax)	Pre-dose and up to 144 hours post-dose
Safety: Incidence of adverse events	approximately 13 weeks
Pharmacokinetics: Absolute bioavailability (F)	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: 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