A Drug-Drug Interaction Study Between GDC-0853 and Midazolam, Itraconazole, Rosuvastatin, and Simvastatin
NCT ID: NCT03174041
Last Updated: 2019-09-24
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
63 participants
INTERVENTIONAL
2017-04-18
2017-06-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Part 1
Participants will receive a single dose of midazolam followed by multiple doses of GDC-0853 coadministered with a single dose of midazolam.
Midazolam
Single dose midazolam
GDC-0853
Multiple doses GDC-0853 for 6 days
Midazolam and GDC-0853
Multiple doses GDC-0853 and single dose midazolam
Part 2
Participants will receive a single dose of rosuvastatin followed by multiple doses of GDC-0853 coadministered with a single dose of rosuvastatin.
GDC-0853
Multiple doses GDC-0853 for 6 days
Rosuvastatin
Single dose rosuvastatin
Rosuvastatin and GDC-0853
Multiple doses GDC-0853 and single dose rosuvastatin
Part 3
Participants will receive a single dose of simvastatin followed by multiple doses of GDC-0853 coadministered with a single dose of simvastatin.
GDC-0853
Multiple doses GDC-0853 for 6 days
Simvastatin
Single dose simvastatin
Simvastatin and GDC-0853
Multiple doses GDC-0853 and single dose simvastatin
Part 4
Participants will receive a single dose of GDC-0853 followed by multiple doses of itraconazole coadministered with a single dose of GDC-0853.
GDC-0853
Single dose GDC-0853
Itraconazole
Multiple doses itraconazole for 6 days
GDC-0853 and itraconazole
Multiple doses itraconazole and single dose GDC-0853
Interventions
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Midazolam
Single dose midazolam
GDC-0853
Multiple doses GDC-0853 for 6 days
Midazolam and GDC-0853
Multiple doses GDC-0853 and single dose midazolam
Rosuvastatin
Single dose rosuvastatin
Rosuvastatin and GDC-0853
Multiple doses GDC-0853 and single dose rosuvastatin
Simvastatin
Single dose simvastatin
Simvastatin and GDC-0853
Multiple doses GDC-0853 and single dose simvastatin
GDC-0853
Single dose GDC-0853
Itraconazole
Multiple doses itraconazole for 6 days
GDC-0853 and itraconazole
Multiple doses itraconazole and single dose GDC-0853
Eligibility Criteria
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Inclusion Criteria
* Females will be non-pregnant, non-lactating, and either postmenopausal or surgically sterile
* Males will either be sterile or agree to use an approved method of contraception
Exclusion Criteria
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
* Participation in any other investigational study drug trial in which receipt of any investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to check in
* History of malignancy, except for appropriately treated carcinoma in situ of the cervix or non-melanoma skin carcinoma with 3-year disease-free follow up
* Any acute or chronic condition or any other reason that, in the opinion of the investigator, would limit the participant's ability to complete and/or participate in this clinical study
18 Years
60 Years
ALL
Yes
Sponsors
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Genentech, Inc.
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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Covance Research Unit - Daytona
Daytona Beach, Florida, United States
Covance Clinical Research Unit Inc.; Covance Gfi Research
Evansville, Indiana, United States
Covance Clinical Research Unit, Inc
Madison, Wisconsin, United States
Countries
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Other Identifiers
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GP39616
Identifier Type: -
Identifier Source: org_study_id
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