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

NCT01873508 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-09-10

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01873508 on ClinicalTrials.gov