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: July 7, 2014
Last verified: July 2014
  Purpose

This two-part, randomized, double-blind, placebo-controlled study will assess th e safety, pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of RO5285119 in healthy volunteers. Anticipated time on study will b e 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
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, see Learn About Clinical Studies.

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: July 7, 2014
Health Authority: France: Ministry of Health

ClinicalTrials.gov processed this record on July 26, 2014