A Study of RO5285119 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: RO5285119; Drug: placebo

• Registration Number: NCT01418963
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-16
• Study First Posted: 2011-08-17
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	RO5285119	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	up to 5 weeks

Secondary Outcome Measures

Name	Time	Method
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