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

Healthy Participants Clinical Trial

Official title:

A 4-Part Phase 1 Study to Evaluate the Effect of GDC-0853 on the Pharmacokinetics of Midazolam, Rosuvastatin, and Simvastatin and the Effect of Itraconazole on the Pharmacokinetics of GDC-0853

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03174041
• Other study ID #: GP39616
• Status: Completed
• Phase: Phase 1
• Start date: April 18, 2017
• Est. completion date: June 23, 2017

Study information

• Verified date: September 2019
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 23, 2017
• Est. primary completion date: June 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Concentration (Cmax)	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.	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
Primary	Area Under the Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC0-t)	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.	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
Secondary	Percentage of Participants with Adverse Events (AEs) and AEs of Special Interest (AESIs)	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.	Up to approximately 7 weeks
Secondary	Cmax	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.	0.5 up to 12 hours post-dose on Days 11 and 12
Secondary	AUC0-12	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.	0.5 up to 12 hours post-dose on Days 11 and 12