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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: valproate; Drug: RO4917838

Study type: Interventional

Funder types: Industry

Identifiers

NCT01495104

2011-002256-14 (EudraCT Number)

BP25258

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

18 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Drug: RO4917838

Drug: valproate