A Pharmacokinetic Study of RO4917838 in Healthy Chinese Volunteers

NCT01433575 | Completed Phase 1

• 1 other identifier: BP25274
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics: Area under the concentration-time curve (AUC)

  12 days

• Pharmacokinetics: Peak plasma concentrations (Cmax)

  12 days

Secondary Outcomes (1)

• Safety: Incidence of adverse events

  approximately 4 months

Study Arms (2)

A

EXPERIMENTAL

Drug: RO4917838

B

EXPERIMENTAL

Drug: RO4917838

Interventions

RO4917838 DRUG

10 mg single oral dose

A

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Beijing, 100083, China

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 14, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

CN (1)