A Drug-Drug Interaction Study Between GDC-0853 and Midazolam, Itraconazole, Rosuvastatin, and Simvastatin
Completed · Phase 1
Conditions studied: Healthy Participants
In brief
The purpose of this study is to assess the potential for a drug interaction between GDC-0853 and midazolam, itraconazole, rosuvastatin, and simvastatin.
Key facts
- Study ID
- NCT03174041
- Run by
- Genentech, Inc.
- People needed
- 63
- Starts
- 2017-04-18
- Expected to finish
- 2017-06-23
- Last updated by the study team
- 2019-09-24
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Within body mass index range of 18 to 31 kilograms per square meter, inclusive
- 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
You may not qualify if…
- Significant history or clinical manifestation of any significant metabolic, allergic/immunologic/immunodeficiency, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the investigator)
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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