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Main
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Note: This record shows only the 20 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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13 May 2013 |
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Main ID: |
NCT01409369 |
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Date of registration:
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03/08/2011 |
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Primary sponsor: |
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Public title:
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A Study on The Effect of Multiple Doses of Activated Charcoal on The Pharmacokinetics of a Single Dose of RO4995819
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Scientific title:
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A Single-Center, Open-Label, Two-Period Crossover Study to Investigate the Effect of Multiple Doses of Activated Charcoal on the Pharmacokinetics of a Single Oral Dose of RO4995819 in Healthy Subjects. |
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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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26 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01409369 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
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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 subjects, 18 to 65 years of age, inclusive
- Body mass index (BMI) 18 to 30 kg/m2 inclusive
- All subjects must agree to use a barrier method (e.g. condom) throughout the study
and for up to 5 months after the last dose of study drug
- Significant past or present disorders of the central nervous system, psychiatric
disorders or behavioral disturbances.
Exclusion Criteria:
- Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse
- Positive for hepatitis B, hepatitis C, or HIV 1 or HIV 2
- Participation in an investigational drug or device study within 3 months prior to
first administration of the study drug
- Any confirmed allergic reaction against any drug or multiple allergies
- Dietary restrictions that would prohibit the consumption of standardized meals
- Positive cotinine test and/or any use of nicotine containing products
- Clinically relevant history of constipation or bowel disorder
- Known intolerability to activated charcoal
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Male
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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: activated charcoal
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Drug: RO4995819
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Primary Outcome(s)
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AUC: area under the plasma concentration-time curve
[Time Frame: 18 weeks]
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C max: maximum observed plasma concentration
[Time Frame: 18 weeks]
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T max: time of maximum observed plasma concentration
[Time Frame: 18 weeks]
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T1/2: apparent terminal half-life
[Time Frame: 18 weeks]
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Secondary ID(s)
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2011-000916-24
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BP25485
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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