A Pharmacokinetic Study of RO4917838 in Healthy Chinese Volunteers

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: RO4917838; Drug: RO4917838

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100083

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: B	Drug: RO4917838; 10 mg single oral dose; Drug: RO4917838; 20 mg single oral dose
EXPERIMENTAL: A	Drug: RO4917838; 10 mg single oral dose; Drug: RO4917838; 20 mg single oral dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics: Area under the concentration-time curve (AUC)	12 days
Pharmacokinetics: Peak plasma concentrations (Cmax)	12 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety: Incidence of adverse events	approximately 4 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): November 1, 2011

Study Registration Dates

• First Submitted: August 31, 2011
• First Submitted That Met QC Criteria: September 13, 2011
• First Posted (ESTIMATE): September 14, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: BP25274