A Study of RO5024048 in Japanese and Caucasian Healthy Volunteers

Healthy Volunteer Clinical Trial

Official title:

A Multiple Center Randomized, Double-Blind, Single-Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics Following Oral Administration of RO5024048 in Healthy Japanese and Caucasian Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01152671
• Other study ID #: PP25311
• Status: Completed
• Phase: Phase 1
• First received: June 25, 2010
• Last updated: November 1, 2016
• Start date: June 2010
• Est. completion date: August 2010

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This randomized, double-blind, placebo-controlled study will assess the safety, tolerability and pharmacokinetics of RO5024048. Japanese and Caucasian healthy volunteers will be randomized to receive either single oral doses of RO5024048 or placebo. Follow-up is 7-10 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male and female adults, 20 to 55 years of age, inclusive

• Body mass index (BMI) 18 - 30 kg/m2 inclusive

• Non-smoker, or previous smoker who discontinued smoking >/= 6 month prior to study entry

• Japanese subjects must be first generation: born in Japan, not having lived outside Japan >5 years, able to trace maternal and paternal Japanese ancestry

• Female subjects of childbearing potential and male subjects and their partners of childbearing potential must agree to use two forms of contraception

• Agree to abstain from alcohol consumption and from strenuous exercise up to 3 days before dosing and throughout study (including the follow-up visit)

Exclusion Criteria:

• Positive pregnancy test

• Males whose female partner is pregnant or trying to become pregnant

• Positive urine test for drugs of abuse

• Positive for alcohol

• Positive result on hepatitis B, hepatitis C, or HIV test

• Clinically significant disease or abnormalities in laboratory parameters

• Participation in an investigational drug, biologic or device study within 3 months before study drug administration

• Donation or loss of any blood over 450 mL within 3 months before study drug administration

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Placebo
single oral dose
• RO5024048
single oral dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of RO4995855 (parent of the prodrug RO5024048) and its metabolite(s)		Day 1 to Day 4	No
Secondary	Safety and tolerability: Adverse events, laboratory parameters, ECG		Day 1 to Day 10	No