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CompletedNCT01665976Updated Nov 2, 2016

A Study of the Relative Bioavailability of Single Dose RO4917838 and the Effect of Food in Healthy Volunteers

A Phase 1 interventional study of RO4917838 and RO4917838 in Healthy Volunteer, sponsored by Hoffmann-La Roche. Completed at 1 site in France. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Hoffmann-La Roche · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

This single center, randomized, single dose, open-label, four period cross-over study will evaluate the relative bioavailability of RO4917838 and the effect of food following oral administration in healthy volunteers. Subjects will receive in randomized order single oral doses of RO4917838 film coated tablets, either in the fasted or fed condition, or RO4917838 hard gelatin capsules or RO4917838 oral suspension, with a washout period of at least 21 days between treatments. Anticipated time on study will be up to 23 weeks.

02

Conditions studied

  • Healthy Volunteer
03

In context

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy male and female volunteers, 18 to 65 years of age, inclusive
  • Body mass index (BMI) 18 to 30 kg/m2 inclusive
  • Healthy as determined by the Investigator on the basis of medical and surgical history and a complete physical examination
  • Non-smoker or smoker of fewer than 10 cigarettes per day; subject must be able to refrain from smoking during the in-patient stays
  • Females who are not postmenopausal or surgically sterile must agree to use two adequate methods of contraception as defined by protocol during the treatment period and for at least one month after the last dose of study drug

Exclusion criteria

Exclusion Criteria:

  • Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator
  • History of alcoholism, drug abuse and/or drug addiction within the last year prior to Period 1. Day -1 of the study
  • History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, psychiatric disease, or cancer
  • Any history of depressive episodes or treatment with antidepressants
  • Any significant allergic reactions against any drug, or multiple allergies in the judgement of the Investigator
  • Pregnant or lactating females
  • Positive for hepatitis B, hepatitis C or HIV infection
  • Participation in another investigational study of any type within 90 days of RO4917838 administration or within 6 times the elimination half-life of the tested drug, whichever is longer
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    A: film coated tablets, fasted condition

    Drug: RO4917838

  • Experimental
    B: film coated tablets, fed condition

    Drug: RO4917838

  • Experimental
    C: hard gelatin capsules

    Drug: RO4927838

  • Experimental
    D: oral suspension

    Drug: RO4917838

Interventions

  • DrugRO4917838

    film coated tablet, single dose

  • DrugRO4917838

    oral suspension, single dose

  • DrugRO4927838

    hard gelatin capsule, single dose

06

What researchers measure

Primary outcomes

  1. Effect of high fat and high caloric food on the relative bioavailability of single dose RO4917838 film coated tablets (FCT): Area under the concentration-time curve (AUC)

    Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12

  2. Relative bioavailability of single dose RO4917838 hard gelatin capsules as compared to FCT: Area under the concentration-time curve

    Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12

  3. Relative bioavailability of single dose RO4917838 oral suspension as compared to FCT

    Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12

Secondary outcomes

  1. Safety: Incidence of adverse events

    Time frame: approximately 2 months

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Study locations

1 site
  • Rueil-Malmaison, 92502, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01665976
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Aug 16, 2012
Start date
Aug 2012
Primary completion
Nov 2012
Completion
Nov 2012
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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