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Completed

NCT Number: NCT01495104

A Study on the Effects of Valproate on the Pharmacokinetics of RO4917838 in Healthy Volunteers

This open-label, fixed-sequence, two-period study will assess the effect of multiple dose valproate on the pharmacokinetics of RO4917838 at steady state and vice versa in healthy male volunteers. In Period 1, subjects will receive valproate for 5 days. After a washout period of 5 days to 2 weeks, subjects will receive, in Period 2, RO4917838 for 15 days with concomitant valproate on Days 11-15. Anticipated time on study is up to 12 weeks.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Rueil-Malmaison, 92502, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male volunteers, 18 to 65 years of age inclusive
  • Body mass index (BMI) 18 to 30 kg/m2 inclusive
  • Healthy as determined by the investigator on the basis of medical/surgical history, physical examination, clinical laboratory test results, vital signs, and a 12-lead electrocardiogram (ECG)
  • Non smoker or smoker of fewer than 10 cigarettes per day

Exclusion criteria

  • History of alcoholism, drug abuse or addiction within the last year prior to Day -1 of the study
  • Alcohol consumption averaging more than 24 g of alcohol per day
  • History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, psychiatric disease, or cancer
  • Any major illness within the 4 weeks prior to dosing or any acute disease state (e.g. nausea, vomiting, fever, diarrhea) within 7 days of study Day -1
  • Any confirmed allergic reactions against any drug, or multiple allergies in the judgment of the investigator
  • Positive for hepatitis B, hepatitis C or HIV infection
  • Involvement in other investigational studies of any type within 90 days of first study drug administration or within 5 times the elimination half-life of the tested drug, whichever is longer

Treatment and study plan

RO4917838

Drug

Multiple doses

Valproate

Drug

Multiple doses

Primary outcomes

  1. Effect of valproate multiple-dose administration on pharmacokinetics of RO4917838 at steady-state: Area under the concentration-time curve (AUC)

    Time frame: Period 2, day 10 and day 15

  2. Effect of RO4917838 multiple-dose administration on the pharmacokinetics of valproate at steady state: Area under the concentration-time curve (AUC)

    Time frame: Period 1, day 5 and Period 2, Day 15

Secondary outcomes

  1. Safety: Incidence of adverse events

    Time frame: 16 days

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A SINGLE CENTER, OPEN LABEL, FIXED SEQUENCE, TWO-PERIOD STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSE VALPROATE ON THE PHARMACOKINETICS OF RO4917838 AND VICE VERSA IN HEALTHY MALE VOLUNTEERS

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 19, 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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