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Trial record 8 of 11 for:    GDC-0853

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

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ClinicalTrials.gov Identifier: NCT03174041
Recruitment Status : Completed
First Posted : June 2, 2017
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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.

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: Midazolam Drug: GDC-0853 Drug: Midazolam and GDC-0853 Drug: Rosuvastatin Drug: Rosuvastatin and GDC-0853 Drug: Simvastatin Drug: Simvastatin and GDC-0853 Drug: Itraconazole Drug: GDC-0853 and itraconazole Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : February 27, 2017
Actual Primary Completion Date : June 23, 2017
Actual Study Completion Date : June 23, 2017


Arm Intervention/treatment
Experimental: Part 1
Participants will receive a single dose of midazolam followed by multiple doses of GDC-0853 coadministered with a single dose of midazolam.
Drug: Midazolam
Single dose midazolam

Drug: GDC-0853
Multiple doses GDC-0853 for 6 days

Drug: Midazolam and GDC-0853
Multiple doses GDC-0853 and single dose midazolam

Experimental: Part 2
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
Multiple doses GDC-0853 for 6 days

Drug: Rosuvastatin
Single dose rosuvastatin

Drug: Rosuvastatin and GDC-0853
Multiple doses GDC-0853 and single dose rosuvastatin

Experimental: Part 3
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
Multiple doses GDC-0853 for 6 days

Drug: Simvastatin
Single dose simvastatin

Drug: Simvastatin and GDC-0853
Multiple doses GDC-0853 and single dose simvastatin

Experimental: Part 4
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
Single dose GDC-0853

Drug: Itraconazole
Multiple doses itraconazole for 6 days

Drug: GDC-0853 and itraconazole
Multiple doses itraconazole and single dose GDC-0853




Primary Outcome Measures :
  1. Maximum Observed Concentration (Cmax) [ Time Frame: 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.

  2. Area Under the Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC0-t) [ Time Frame: 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 Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) and AEs of Special Interest (AESIs) [ Time Frame: 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.

  2. Cmax [ Time Frame: 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.

  3. AUC0-12 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03174041


Locations
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United States, Florida
Covance Research Unit - Daytona
Daytona Beach, Florida, United States, 32117
United States, Indiana
Covance Clinical Research Unit Inc.; Covance Gfi Research
Evansville, Indiana, United States, 47710
United States, Wisconsin
Covance Clinical Research Unit, Inc
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03174041     History of Changes
Other Study ID Numbers: GP39616
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Midazolam
Rosuvastatin Calcium
Simvastatin
Itraconazole
Hydroxyitraconazole
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Steroid Synthesis Inhibitors