ClinicalTrials.gg
CompletedNCT01183585Updated Nov 2, 2016

A Study of RO4917838 With Rosuvastatin in Healthy Volunteers

A Phase 1 interventional study of RO4917838 and Rosuvastatin in Healthy Volunteer, sponsored by Hoffmann-La Roche. Completed at 1 site in France. Open to 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, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This single centre, open-label study will investigate the effect of RO4917838 on the pharmacokinetics of Rosuvastatin, a frequently co-prescribed drug in healthy volunteers. Healthy volunteers will receive multiple oral doses of RO4917838 and single oral dose of Rosuvastatin.

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Conditions studied

  • Healthy Volunteer
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In context

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,099 studies on the registry; 88 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 245 (76%) 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
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult healthy volunteers, 18 to 65 years of age
  • A body mass index (BMI) between 18 to 30 kg/m2

Exclusion criteria

Exclusion Criteria:

  • History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis (Gilbert's Syndrome is allowed)
  • Diseases or medical conditions that are capable of altering the absorption, metabolism or elimination of drugs
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    1

    Drug: RO4917838 and Rosuvastatin

Interventions

  • DrugRO4917838 and Rosuvastatin

    Drug pages: Bitopertin · Rosuvastatin

    multiple oral doses of RO4917838 and single oral dose of Rosuvastatin

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What researchers measure

Primary outcomes

  1. To determine the effect of multiple doses of RO4917838 on single-dose pharmacokinetics of Rosuvastatin

    Time frame: 30 days

Secondary outcomes

  1. To evaluate the safety and tolerability of single-dose Rosuvastatin and multiple-dose RO4917838 alone and in combination

    Time frame: 30 days

  2. To explore the effect of single-dose Rosuvastatin on steady-state pharmacokinetics of RO4917838

    Time frame: 30 days

07

Study locations

1 site
  • Strasbourg, 67064, France
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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 ↗
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Registry details

Key details

Study ID
NCT01183585
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Aug 17, 2010
Start date
Aug 2010
Primary completion
Sep 2010
Completion
Sep 2010
Last update
Nov 2, 2016

Study contacts

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

Not currently enrolling

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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Studies of the drugs tested here: Bitopertin · Rosuvastatin

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