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

NCT01495104 | Completed Phase 1

• 2 other identifiers: BP252582011-002256-14
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Safety: Incidence of adverse events

  16 days

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: RO4917838; Drug: valproate

Interventions

RO4917838 DRUG

Multiple doses

Single Arm

valproate DRUG

Multiple doses

Single Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Rueil-Malmaison, 92502, France

Location

MeSH Terms

Interventions

Valproic Acid

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: December 19, 2011
• Study Start: October 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

FR (1)