Completed

A Single- and Multiple Ascending-Dose, Randomized, Double-Blind, Placebo-Controlled Study in Two Single-Center Study Parts to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5285119 Following Oral Administration in Healthy Subjects

What is being tested

RO5285119

+ placebo

Drug

Who is being recruted

From 18 to 65 Years

+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Placebo-ControlledPhase 1

Interventional

Study Start: July 2011

See protocol details

Summary

Principal SponsorHoffmann-La Roche

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2011

Actual date on which the first participant was enrolled.

This two-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of RO5285119 in healthy volunteers. Anticipated time on study will be up to 9 weeks for each subject.

Official TitleA Single- and Multiple Ascending-Dose, Randomized, Double-Blind, Placebo-Controlled Study in Two Single-Center Study Parts to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5285119 Following Oral Administration in Healthy Subjects

NCT01418963

Principal SponsorHoffmann-La Roche

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

77 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate

Healthy male adults, 18 to 45 years of age (Part 1) or healthy male or female adults, 18 to 65 years of age (Part 2)

Body mass index (BMI) 18.0 to 30.0 kg/m2 inclusive

Female subjects must be surgically sterile or postmenopausal

Male subjects must use a barrier method of contraception for the duration of the study and for the three months after the last dosing

8 exclusion criteria prevent from participating

History or presence of any significant disease or disorder

Positive for hepatitis B. hepatitis C or HIV infection

History of drug or alcohol abuse or suspicion of regular consumption of drugs of abuse

Participation in an investigational drug or device study within 3 months prior to first dosing

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

CompletedNo study centers