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

Genentech

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Rosuvastatin; Drug: Simvastatin; Drug: GDC-0853; Drug: GDC-0853 and itraconazole; Drug: Midazolam; Drug: Itraconazole; Drug: Midazolam and GDC-0853; Drug: Simvastatin and GDC-0853; Drug: Rosuvastatin and GDC-0853

Study type: Interventional

Funder types: Industry

Identifiers

NCT03174041

GP39616

Details and patient eligibility

About

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

Full description

This will be a 4-part study, with each part being an open-label fixed-sequence evaluation conducted in healthy adult participants. Approximately 64 participants will be enrolled in this study.

Enrollment: 63 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 4 patient groups

Part 1

Experimental group

Description:

Participants will receive a single dose of midazolam followed by multiple doses of GDC-0853 coadministered with a single dose of midazolam.

Treatment:

Drug: Midazolam and GDC-0853

Drug: Midazolam

Drug: GDC-0853

Drug: GDC-0853

Part 2

Experimental group

Description:

Participants will receive a single dose of rosuvastatin followed by multiple doses of GDC-0853 coadministered with a single dose of rosuvastatin.

Treatment:

Drug: Rosuvastatin

Drug: GDC-0853

Drug: Rosuvastatin and GDC-0853

Drug: GDC-0853

Part 3

Experimental group

Description:

Participants will receive a single dose of simvastatin followed by multiple doses of GDC-0853 coadministered with a single dose of simvastatin.

Treatment:

Drug: GDC-0853

Drug: Simvastatin

Drug: GDC-0853

Drug: Simvastatin and GDC-0853

Part 4

Experimental group

Description:

Participants will receive a single dose of GDC-0853 followed by multiple doses of itraconazole coadministered with a single dose of GDC-0853.

Treatment:

Drug: Itraconazole

Drug: GDC-0853

Drug: GDC-0853 and itraconazole

Drug: GDC-0853