A Drug-Drug Interaction Study Between GDC-0853 and Midazolam, Itraconazole, Rosuvastatin, and Simvastatin

• Status: Completed
• Trial end date: 2017-06-23
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the potential for a drug interaction between GDC-0853 and midazolam, itraconazole, rosuvastatin, and simvastatin.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Hydroxyitraconazole; Itraconazole; Midazolam; Rosuvastatin Calcium; Simvastatin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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