A Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of RO6864018 in Male, Healthy, Asian Participants
NCT ID: NCT02015715
Last Updated: 2017-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2013-12-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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RO6864018
Asian participants will receive a single oral dose of RO6864018 capsule on Day 1. The first dose escalation cohort will receive a single 400 mg oral dose. Dose will be escalated in subsequent cohorts (up to Cohort 4) up to a maximum of 1600 mg, based on safety, pharmacokinetic, and pharmacodynamic data available from lower dose cohorts. The Cohort 5 will include Caucasian participants who will receive a single 1200 mg (or the highest dose well-tolerated by Asian participants, if lower than 1200 mg) oral dose of RO6864018 capsules on Day 1.
RO6864018
A single oral ascending dose of RO6864018 capsules on Day 1.
Placebo
Participants will receive a single oral dose of placebo matching to RO6864018.
Placebo
A single oral dose of placebo matching RO6864018 capsules on Day 1.
Interventions
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RO6864018
A single oral ascending dose of RO6864018 capsules on Day 1.
Placebo
A single oral dose of placebo matching RO6864018 capsules on Day 1.
Eligibility Criteria
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Inclusion Criteria
* No signs of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology and urinalysis
* Body Mass Index (BMI) between 18 to 30 kilograms per square meter (kg/m\^2) inclusive, and a weight range of 50 to 100 kilograms (kg) (110 to 220 pounds \[lb\]) inclusive at screening
* Non-smokers, or use of less than (\<) 10 cigarettes (or equivalent nicotine-containing product) per day
Exclusion Criteria
* Personal or family history of congenital long QT syndrome or sudden death
* Any confirmed significant allergic reactions against any drug, or multiple drug allergies (non-active hay fever is acceptable)
* Positive results for anti-nuclear antibody (ANA), anti-mitochondrial antibody (AMA), anti-smooth muscle antibody (ASMA) and thyroid peroxidase antibody
* Suspicion of regular consumption of drug of abuse
* History (within 3 months of screening) of alcohol consumption exceeding 14 units per week on average (1 unit = 10 grams of alcohol)
* Participants who have received Interferon (IFN) or peginterferon within 8 weeks prior to dosing
* Use of any medication (prescription or over the counter \[OTC\], including health supplements and herbal remedies) within 2 weeks before the first dose of study medication
* Positive Hepatitis A immunoglobulin M antibody (HAV IgM Ab), Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab) or human immunodeficiency virus antibody (HIV Ab) at screening
* Donation or loss of blood of greater than 500 milliliters (mL) within 90 days prior to dosing
* Have participated in other clinical studies within 60 days prior to study randomization
21 Years
65 Years
MALE
Yes
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Changi General Hospital; Clinical Trial & Research unit
Singapore, , Singapore
Singapore, , Singapore
Countries
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Other Identifiers
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YP29017
Identifier Type: -
Identifier Source: org_study_id
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