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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 November 2016 |
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Main ID: |
NCT01398241 |
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Date of registration:
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14/07/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of RO5267683 in Healthy Subjects
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Scientific title:
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Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5267683 in an Adaptive, Randomized, Investigator-blind and Subject-blind, Multiple-ascending Dose, Placebo-controlled, Study Following Oral Administrations in Healthy Subjects for 28 Days |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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38 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01398241 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
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Phase:
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Phase 1
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Countries of recruitment
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France
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy male and female subjects, 18 to 45 years of age,
- Body mass index (BMI) 18 to 30 kg/m2 inclusive, and a minimum weight of 50 kg at
screening
- Female subjects must be surgically sterile or post-menopausal
- Male subjects must use a barrier method of contraception for the duration of the
study and for 90 days after the last dose
Exclusion Criteria:
- History or evidence of any clinically significant disease or disorder
- Administration of an investigational drug or device within 3 months prior to dosing
on Day 1
- Positive for hepatitis B, hepatitis C or HIV at screening
- Subjects on hormone replacement therapy who have not been receiving a stable dose for
at least 2 months prior to start of dosing
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy Volunteer
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Intervention(s)
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Drug: placebo
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Drug: RO5267683
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Primary Outcome(s)
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Safety: Incidence of adverse events
[Time Frame: 14 weeks]
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Secondary Outcome(s)
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Lipid levels in the blood
[Time Frame: 14 weeks]
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Pharmacokinetics: Urine concentrations
[Time Frame: 4 weeks]
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Pharmacokinetics: Plasma concentrations
[Time Frame: 14 weeks]
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Secondary ID(s)
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2011-000600-17
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BP25214
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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