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A Study of RO5285119 in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01418963
First Posted: August 17, 2011
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01418963     History of Changes
Other Study ID Numbers: BP25694
First Submitted: August 15, 2011
First Posted: August 17, 2011
Last Update Posted: November 2, 2016
Last Verified: November 2016