Marlton, New Jersey, 08053, United States
NCT Number: NCT01873508
A Study of Three Modified-Release Formulations of RO4917523 in Healthy Volunteers
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.
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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
RO4917523
DrugFast release MR capsule, single dose
Primary outcomes
-
Pharmacokinetics: Area under the concentration-time curve (AUC)
Time frame: Pre-dose and up to 144 hours post-dose
-
Pharmacokinetics: Maximum concentration (Cmax)
Time frame: Pre-dose and up to 144 hours post-dose
Secondary outcomes
-
Pharmacokinetics: Time to maximum plasma concentration (tmax)
Time frame: Pre-dose and up to 144 hours post-dose
-
Pharmacokinetics: Elimination half-life (t1/2)
Time frame: Pre-dose and up to 144 hours post-dose
-
Pharmacokinetics: Elimination rate constant: (kel)
Time frame: Pre-dose and up to 144 hours post-dose
-
Pharmacokinetics: Absolute bioavailability (F)
Time frame: Pre-dose and up to 144 hours post-dose
-
Pharmacokinetics: Total body clearance (CL)
Time frame: Pre-dose and up to 144 hours post-dose
-
Pharmacokinetics: Volume of distribution (Vd)
Time frame: Pre-dose and up to 144 hours post-dose
-
Safety: Incidence of adverse events
Time frame: approximately 13 weeks
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Lead sponsor
Hoffmann-La Roche
Industry
Registry information
Official study 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
Important dates
- Study start
- 2013
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Jun 10, 2013
- Registry last updated
- Sep 10, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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