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NCT Number: NCT01433575

A Pharmacokinetic Study 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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing, 100083, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO4917838

Drug

10 mg single oral dose

Primary outcomes

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

    Time frame: 12 days

  2. Pharmacokinetics: Peak plasma concentrations (Cmax)

    Time frame: 12 days

Secondary outcomes

  1. Safety: Incidence of adverse events

    Time frame: approximately 4 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 14, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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