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A Pharmacokinetic Study of RO4917838 in Healthy Chinese Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01433575
First received: August 31, 2011
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

This single-center, open-label, single dose, randomized, two-way cross-over stud y will evaluate the pharmacokinetics, safety and tolerability of RO4917838 in he althy Chinese volunteers. Subjects will be randomized to receive a single oral d ose of either 10 mg or 20 mg RO4917838 and, after a washout period of at least 2

1 but no more than 35 days, will be re-dosed with the alternative treatment. Ant icipated time on study is up to 70 days.


Condition Intervention Phase
Healthy Volunteer
Drug: RO4917838
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Peak plasma concentrations (Cmax) [ Time Frame: 12 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433575

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01433575     History of Changes
Other Study ID Numbers: BP25274
Study First Received: August 31, 2011
Last Updated: November 3, 2014
Health Authority: China: Food and Drug Administration

ClinicalTrials.gov processed this record on November 20, 2014