Healthy Participants
Conditions
Brief summary
The purpose of this study is to assess the potential for a drug interaction between GDC-0853 and midazolam, itraconazole, rosuvastatin, and simvastatin.
Detailed 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.
Interventions
DRUGMidazolam
Single dose midazolam
DRUGGDC-0853
Multiple doses GDC-0853 for 6 days
DRUGMidazolam and GDC-0853
Multiple doses GDC-0853 and single dose midazolam
DRUGRosuvastatin
Single dose rosuvastatin
DRUGRosuvastatin and GDC-0853
Multiple doses GDC-0853 and single dose rosuvastatin
DRUGSimvastatin
Single dose simvastatin
DRUGSimvastatin and GDC-0853
Multiple doses GDC-0853 and single dose simvastatin
DRUGItraconazole
Multiple doses itraconazole for 6 days
DRUGGDC-0853 and itraconazole
Multiple doses itraconazole and single dose GDC-0853
Sponsors
Genentech, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Concentration (Cmax) | Part 1: Pre-dose, 0.5 up to 48 hours post-dose Days 1, 9. Part 2: pre-dose, 0.5 up to 96 hours post-dose Days 1, 12. Part 3: pre-dose, 0.5 up to 48 hours post-dose on Days 1, 9. Part 4: pre-dose, 0.5 up to 48 hours post-dose Days 1, 10 | Cmax for midazolam (Part 1), rosuvastatin (Part 2), and simvastatin (Part 3) in the presence and absence of GDC-0853 and Cmax for GDC-0853 (Part 4) in the presence and absence of itraconazole. |
| Area Under the Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC0-t) | Part 1: Pre-dose, 0.5 up to 48 hours post-dose Days 1, 9. Part 2: pre-dose, 0.5 up to 96 hours post-dose Days 1, 12. Part 3: pre-dose, 0.5 up to 48 hours post-dose on Days 1, 9. Part 4: pre-dose, 0.5 up to 48 hours post-dose Days 1, 10 | AUC0-t for midazolam (Part 1), rosuvastatin (Part 2), and simvastatin (Part 3) in the presence and absence of GDC-0853 and AUC0-t for GDC-0853 (Part 4) in the presence and absence of itraconazole. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with Adverse Events (AEs) and AEs of Special Interest (AESIs) | Up to approximately 7 weeks | An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. AESIs include any serious infection, any infections requiring intravenous antimicrobials, and any opportunistic infections; bleeding events of moderate or greater severity; a laboratory result of aspartate aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>5 × upper limit of normal (ULN) or an AST or ALT \> 3 × ULN in combination with a total bilirubin \> 2 × ULN, of which at least 35% is direct bilirubin or there is clinical jaundice; cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's law; or suspected transmission of an infectious agent by the study drug. |
| Cmax | 0.5 up to 12 hours post-dose on Days 11 and 12 | Cmax for GDC-0853 (Parts 2 and 3) in the presence and absence of rosuvastatin and simvastatin, respectively, and Cmax for itraconazole (Part 4) in the presence and absence of GDC-0853. |
| AUC0-12 | 0.5 up to 12 hours post-dose on Days 11 and 12 | AUC0-12 for GDC-0853 (Parts 2 and 3) in the presence and absence of rosuvastatin and simvastatin, respectively, and AUC0-12 for itraconazole (Part 4) in the presence and absence of GDC-0853. |
Countries
United States
Outcome results
None listed