Clinical trial NCT01873508: A Study of Three Modified-Release Formulations of RO4917523 in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-06-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


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

Primary outcomes:
measure: Pharmacokinetics: Area under the concentration-time curve (AUC)
timeFrame: Pre-dose and up to 144 hours post-dose
measure: Pharmacokinetics: Maximum concentration (Cmax)
timeFrame: Pre-dose and up to 144 hours post-dose
Secondary outcomes:
measure: Pharmacokinetics: Time to maximum plasma concentration (tmax)
timeFrame: Pre-dose and up to 144 hours post-dose
measure: Pharmacokinetics: Elimination half-life (t1/2)
timeFrame: Pre-dose and up to 144 hours post-dose
measure: Pharmacokinetics: Elimination rate constant: (kel)
timeFrame: Pre-dose and up to 144 hours post-dose
measure: Pharmacokinetics: Absolute bioavailability (F)
timeFrame: Pre-dose and up to 144 hours post-dose
measure: Pharmacokinetics: Total body clearance (CL)
timeFrame: Pre-dose and up to 144 hours post-dose
measure: Pharmacokinetics: Volume of distribution (Vd)
timeFrame: Pre-dose and up to 144 hours post-dose
measure: Safety: Incidence of adverse events
timeFrame: approximately 13 weeks
Other outcomes:
Locations:
city: Marlton
country: United States
state: New Jersey
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: