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A Pharmacokinetic Study of RO4917838 in Healthy Chinese Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01433575
First Posted: September 14, 2011
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This single-center, open-label, single dose, randomized, two-way cross-over study will evaluate the pharmacokinetics, safety and tolerability of RO4917838 in healthy Chinese volunteers. Subjects will be randomized to receive a single oral dose of either 10 mg or 20 mg RO4917838 and, after a washout period of at least 21 but no more than 35 days, will be re-dosed with the alternative treatment. Anticipated time on study is up to 70 days.

Condition Intervention Phase
Healthy Volunteer Drug: RO4917838 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Single-center, Open-label, Single Dose, Randomized, Two-way Cross-over Study to Investigate the Pharmacokinetics, Safety, and Tolerability of RO4917838 in Healthy Chinese Volunteers

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: 12 days ]
  • Pharmacokinetics: Peak plasma concentrations (Cmax) [ Time Frame: 12 days ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 months ]

Enrollment: 16
Study Start Date: September 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: RO4917838
10 mg single oral dose
Experimental: B Drug: RO4917838
20 mg single oral dose

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Chinese male and female volunteers, 18 to 45 years of age inclusive at time of screening
  • Healthy status is defined by absence of evidence of any active or chronic disease or disorder following a detailed medical and surgical history and a complete physical examination
  • Body mass index (BMI) 19 to 28 kg/m2 inclusive

Exclusion Criteria:

  • Pregnant or currently lactating females
  • History of any clinically relevant disorder
  • Any history of depressive episodes or treatment with antidepressants
  • History of drug abuse within the past 2 years or positive results for drugs of abuse at screening or Day -1
  • Alcohol dependence or history of this within the past 2 years or positive results for alcohol breath test at screening or Day -1
  • Positive for HIV, hepatitis B or hepatitis C infection
  • Regular smoker with consumption of more than 10 cigarettes a day or equivalent amount of tobacco
  • Participation in a clinical study with an investigational drug or device within the last 3 months prior to dosing
  • Medical history of significant drug allergies
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433575


Locations
China
Beijing, China, 100083
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01433575     History of Changes
Other Study ID Numbers: BP25274
First Submitted: August 31, 2011
First Posted: September 14, 2011
Last Update Posted: November 2, 2016
Last Verified: November 2016