A Study of RO5285119 in Healthy Volunteers

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418963
• Other study ID #: BP25694
• Status: Completed
• Phase: Phase 1
• First received: August 15, 2011
• Last updated: November 1, 2016
• Start date: July 2011
• Est. completion date: July 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO5285119
single and multiple ascending oral doses
• placebo
single and multiple oral doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		up to 5 weeks	No
Secondary	Pharmacokinetics: Area under the concentration - time curve (AUC)		up to 5 weeks	No
Secondary	Pharmacodynamics (neurological effects): Profile of Mood States/Bond&Lader VAS/smell test/C-SSRS		up to 5 weeks	No
Secondary	Pharmacodynamics: Biomarker levels (ACTH, prolactin, cortisol, vasopressin)		up to 5 weeks	No
Secondary	Pharmacodynamics: Functional Magnetic Resonance Imaging		up to 5 weeks	No
Secondary	Food effect: Comparison of single dose pharmacokinetics (AUC) in fasted and fed state (Part 1b)		up to 5 weeks	No