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OpenTrials
Completed

NCT Number: NCT01183585

A Study of RO4917838 With Rosuvastatin in Healthy Volunteers

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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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Strasbourg, 67064, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

RO4917838 and Rosuvastatin

Drug

multiple oral doses of RO4917838 and single oral dose of Rosuvastatin

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Single Center, Open-label, Fixed Sequence, Two-period Study to Investigate the Effect of RO4917838 on the Pharmacokinetics of Rosuvastatin in Healthy Volunteers

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 17, 2010
Registry last updated
Nov 2, 2016

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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