A Study of RO5285119 in Healthy Volunteers
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01418963
First received: August 15, 2011
Last updated: June 3, 2013
Last verified: June 2013
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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 |
| 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 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: | June 3, 2013 |
| Health Authority: | France: Ministry of Health |
ClinicalTrials.gov processed this record on June 18, 2013