A Pharmacokinetic Study of RO4917838 in Healthy Chinese Volunteers

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433575
• Other study ID #: BP25274
• Status: Completed
• Phase: Phase 1
• First received: August 31, 2011
• Last updated: November 1, 2016
• Start date: September 2011
• Est. completion date: November 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO4917838
10 mg single oral dose
• RO4917838
20 mg single oral dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Area under the concentration-time curve (AUC)		12 days	No
Primary	Pharmacokinetics: Peak plasma concentrations (Cmax)		12 days	No
Secondary	Safety: Incidence of adverse events		approximately 4 months	No