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: April 7, 2014
Last verified: April 2014
  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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433575

Locations
China
Beijing, China, 100191
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: April 7, 2014
Health Authority: China: Food and Drug Administration

ClinicalTrials.gov processed this record on April 15, 2014