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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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17 October 2012 |
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Main ID: |
NCT01422369 |
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Date of registration:
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22/08/2011 |
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Primary sponsor: |
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Public title:
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Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin
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Scientific title:
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Drug-Drug Interaction Study to Assess the Effects of Steady-State Darunavir/Ritonavir on Steady-State Pitavastatin in Healthy Adult Volunteers |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01422369 |
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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: Single Group Assignment, Masking: Open Label
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Countries of recruitment
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United States
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Contacts
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Name:
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Roger Morgan, MD, FACS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kowa Research Institute, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy adult male or female volunteer aged 18 to 45 years, inclusive.
- Subject has a body mass index of 18 to 30 kg/m2, inclusive.
- Subject has normal hematology, serum chemistry, and urinalysis test results
- Subject is able and willing to abstain from alcohol, grapefruit, caffeine or caffeine
containing products, St John's wort, and herbal supplements for 4 days before Day 1
and until completion of the study
- Subject is a nonsmoker or has quit smoking at least 6 months before the first dose of
study drug and until study completion.
Exclusion Criteria:
- Subject has had any surgery of the gastrointestinal tract likely to affect drug
absorption, distribution, metabolism, or excretion.
- Subject has had a previous allergy or intolerance to treatment with pitavastatin,
darunavir, ritonavir, sulfonamides, or any drugs in these classes.
- Subject has a history of drug or alcohol abuse.
- Subject has had a clinically significant illness within 4 weeks before the first dose
of study drug.
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
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Intervention(s)
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Drug: Darunavir/Ritonavir (Prezista)
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Drug: Pitavastatin (NK-104)
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Primary Outcome(s)
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NK-104 AUC
[Time Frame: 16 Days]
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Secondary Outcome(s)
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Number of Participants With at Least One Adverse Event.
[Time Frame: 16 Days]
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Secondary ID(s)
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NK-104-4.06US
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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