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

NCT01873508 | Completed Phase 1

• 2 other identifiers: NP287382013-000502-28
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

Study Arms (3)

Fast release MR capsule

EXPERIMENTAL

Drug: RO4917523

Slow release MR capsule

EXPERIMENTAL

Drug: RO4917523

Target release MR capsule

EXPERIMENTAL

Drug: RO4917523

Interventions

RO4917523 DRUG

Fast release MR capsule, single dose

Fast release MR capsule

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Marlton, New Jersey, 08053, United States

Location

MeSH Terms

Interventions

2-chloro-4-(1-(4-fluorophenyl)-2,5-dimethyl-1H-imidazol-4-ylethynyl)pyridine

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: June 10, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 10, 2015

Record last verified: 2015-09

Locations

US (1)