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Completed

NCT Number: NCT01152671

A Study of RO5024048 in Japanese and Caucasian Healthy Volunteers

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.

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Key information

Conditions

Healthy Volunteer

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Glendale, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Placebo

Drug

single oral dose

RO5024048

Drug

single oral dose

Primary outcomes

  1. Pharmacokinetics of RO4995855 (parent of the prodrug RO5024048) and its metabolite(s)

    Time frame: Day 1 to Day 4

Secondary outcomes

  1. Safety and tolerability: Adverse events, laboratory parameters, ECG

    Time frame: Day 1 to Day 10

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2010
Study completion
2010
First posted
Jun 29, 2010
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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