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

Healthy Volunteer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495104
• Other study ID #: BP25258
• Secondary ID: 2011-002256-14
• Status: Completed
• Phase: Phase 1
• First received: December 15, 2011
• Last updated: November 1, 2016
• Start date: October 2011
• Est. completion date: January 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO4917838
Multiple doses
• valproate
Multiple doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of valproate multiple-dose administration on pharmacokinetics of RO4917838 at steady-state: Area under the concentration-time curve (AUC)		Period 2, day 10 and day 15	No
Primary	Effect of RO4917838 multiple-dose administration on the pharmacokinetics of valproate at steady state: Area under the concentration-time curve (AUC)		Period 1, day 5 and Period 2, Day 15	No
Secondary	Safety: Incidence of adverse events		16 days	No