A Study of RO5285119 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01418963
First received: August 15, 2011
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Healthy Volunteer
Drug: RO5285119
Drug: placebo
Phase 1

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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: up to 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics: Area under the concentration - time curve (AUC) [ Time Frame: up to 5 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamics (neurological effects): Profile of Mood States/Bond&Lader VAS/smell test/C-SSRS [ Time Frame: up to 5 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Biomarker levels (ACTH, prolactin, cortisol, vasopressin) [ Time Frame: up to 5 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Functional Magnetic Resonance Imaging [ Time Frame: up to 5 weeks ] [ Designated as safety issue: No ]
  • Food effect: Comparison of single dose pharmacokinetics (AUC) in fasted and fed state (Part 1b) [ Time Frame: up to 5 weeks ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: July 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug: RO5285119
single and multiple ascending oral doses
Placebo Comparator: Placebo Drug: placebo
single and multiple oral doses

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418963

Locations
France
Rennes, France, 35042
Strasbourg, France, 67064
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01418963     History of Changes
Other Study ID Numbers: BP25694
Study First Received: August 15, 2011
Last Updated: April 7, 2014
Health Authority: France: Ministry of Health

ClinicalTrials.gov processed this record on April 17, 2014