A Study of RO5285119 in Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01418963

Enrollment

Registered

2011-08-17

Start date

2011-07-31

Completion date

2012-07-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Brief summary

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.

Interventions

DRUGRO5285119

single and multiple ascending oral doses

DRUGplacebo

single and multiple oral doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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 * Donation of blood within 3 months prior to first dosing * Regular smoker (\>5 cigarettes, \>3 pipe-fulls, \>3 cigars per day) * History of hypersensitivity or allergic reactions * Part 2: Contraindications for MRI scans

Design outcomes

Primary

Measure	Time frame
Safety: Incidence of adverse events	up to 5 weeks

Secondary

Measure	Time frame
Pharmacokinetics: Area under the concentration - time curve (AUC)	up to 5 weeks
Pharmacodynamics (neurological effects): Profile of Mood States/Bond&Lader VAS/smell test/C-SSRS	up to 5 weeks
Pharmacodynamics: Biomarker levels (ACTH, prolactin, cortisol, vasopressin)	up to 5 weeks
Pharmacodynamics: Functional Magnetic Resonance Imaging	up to 5 weeks
Food effect: Comparison of single dose pharmacokinetics (AUC) in fasted and fed state (Part 1b)	up to 5 weeks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026