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

NCT03174041 | Completed Phase 1 FDA Drug

• 1 other identifier: GP39616
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 3

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Percentage of Participants with Adverse Events (AEs) and AEs of Special Interest (AESIs)

  Up to approximately 7 weeks

• Cmax

  0.5 up to 12 hours post-dose on Days 11 and 12

• AUC0-12

  0.5 up to 12 hours post-dose on Days 11 and 12

Study Arms (4)

Part 1

EXPERIMENTAL

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

Drug: Midazolam; Drug: GDC-0853; Drug: Midazolam and GDC-0853

Part 2

EXPERIMENTAL

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

Drug: GDC-0853; Drug: Rosuvastatin; Drug: Rosuvastatin and GDC-0853

Part 3

EXPERIMENTAL

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

Drug: GDC-0853; Drug: Simvastatin; Drug: Simvastatin and GDC-0853

Part 4

EXPERIMENTAL

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

Drug: GDC-0853; Drug: Itraconazole; Drug: GDC-0853 and itraconazole

Interventions

Midazolam DRUG

Single dose midazolam

Part 1

GDC-0853 DRUG

Multiple doses GDC-0853 for 6 days

Part 1; Part 2; Part 3

Midazolam and GDC-0853 DRUG

Multiple doses GDC-0853 and single dose midazolam

Part 1

Rosuvastatin DRUG

Single dose rosuvastatin

Part 2

Rosuvastatin and GDC-0853 DRUG

Multiple doses GDC-0853 and single dose rosuvastatin

Part 2

Simvastatin DRUG

Single dose simvastatin

Part 3

Simvastatin and GDC-0853 DRUG

Multiple doses GDC-0853 and single dose simvastatin

Part 3

Itraconazole DRUG

Multiple doses itraconazole for 6 days

Part 4

GDC-0853 and itraconazole DRUG

Multiple doses itraconazole and single dose GDC-0853

Part 4

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (3)

Covance Research Unit - Daytona

Daytona Beach, Florida, 32117, United States

Location

Covance Clinical Research Unit Inc.; Covance Gfi Research

Evansville, Indiana, 47710, United States

Location

Covance Clinical Research Unit, Inc

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

Midazolam; fenebrutinib; Rosuvastatin Calcium; Simvastatin; Itraconazole

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Triazoles; Azoles; Piperazines

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: June 2, 2017
• Study Start: April 18, 2017
• Primary Completion: June 23, 2017
• Study Completion: June 23, 2017
• Last Updated: September 24, 2019

Record last verified: 2019-09

Locations

US (3)