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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873508
• Other study ID #: NP28738
• Secondary ID: 2013-000502-28
• Status: Completed
• Phase: Phase 1
• First received: June 6, 2013
• Last updated: September 9, 2015
• Start date: June 2013
• Est. completion date: August 2013

Study information

• Verified date: September 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO4917523
Fast release MR capsule, single dose
• RO4917523
Target release MR capsule, single dose
• RO4917523
Slow release MR capsule, single dose
• RO4917523
[13C]-labeled tracer dose i.v.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Area under the concentration-time curve (AUC)		Pre-dose and up to 144 hours post-dose	No
Primary	Pharmacokinetics: Maximum concentration (Cmax)		Pre-dose and up to 144 hours post-dose	No
Secondary	Pharmacokinetics: Time to maximum plasma concentration (tmax)		Pre-dose and up to 144 hours post-dose	No
Secondary	Pharmacokinetics: Elimination half-life (t1/2)		Pre-dose and up to 144 hours post-dose	No
Secondary	Pharmacokinetics: Elimination rate constant: (kel)		Pre-dose and up to 144 hours post-dose	No
Secondary	Pharmacokinetics: Absolute bioavailability (F)		Pre-dose and up to 144 hours post-dose	No
Secondary	Pharmacokinetics: Total body clearance (CL)		Pre-dose and up to 144 hours post-dose	No
Secondary	Pharmacokinetics: Volume of distribution (Vd)		Pre-dose and up to 144 hours post-dose	No
Secondary	Safety: Incidence of adverse events		approximately 13 weeks	No