A Study of RO5285119 in Healthy Volunteers

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. Identifier: NCT01418963
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: RO5285119 Drug: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
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
Study Start Date : July 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
Experimental: Active Drug: RO5285119
single and multiple ascending oral doses

Placebo Comparator: Placebo Drug: placebo
single and multiple oral doses

Primary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: up to 5 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

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 identifier (NCT number): NCT01418963

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

Responsible Party: Hoffmann-La Roche Identifier: NCT01418963     History of Changes
Other Study ID Numbers: BP25694
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016