A Drug Interaction Study of GDC-0032 Co-administered With... | NCT01814709

Studies
A Drug Interaction Study of GDC-0032 Co-administered With Rifampin or Itraconazole in Healthy Volunteers

NCT01814709

Sponsor

Genentech, Inc.

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

32Actual

Phase

Phase 1

Conditions

Healthy Volunteer

Interventions

GDC-0032
Itraconazole
Rifampin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Mar 18, 2013

First Submission Date that Met QC Criteria

Mar 18, 2013

First Posted Date

Mar 20, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

Brief Summary

This open-label, two-arm, drug interaction study will investigate the effect of co-administration of rifampin or itraconazole on the pharmacokinetics of GDC-0032 in healthy volunteers. In Arm A, volunteers will receive GDC-0032 and rifampin; in Arm B, volunteers will receive GDC-0032 and itraconazole. The anticipated time on study treatment is approximately 30 days.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Label	Type	Description	Intervention Names
Itraconazole Arm	Experimental		Drug: GDC-0032 Drug: Itraconazole
Rifampin Arm	Experimental		Drug: GDC-0032 Drug: Rifampin

Name	Type	Description	Arm Group Labels	Other Names
GDC-0032	Drug	Oral doses of GDC-0032	Itraconazole Arm Rifampin Arm

Measure	Description	Time Frame
Pharmacokinetics: Plasma concentrations of GDC-0032		2 months
Safety: Incidence of adverse events		2 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female volunteers will be non-pregnant, non-lactating, and either postmenopausal for at least 1 year or surgically sterile
Male volunteers will either be sterile, or agree to use adequate methods of contraception
Body mass index (BMI) range 18 to 32 kg/m2, inclusive
No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs; and clinical laboratory evaluations
Negative hepatitis B virus, hepatitis C virus and negative HIV antibody screens

Exclusion Criteria:

Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
History of stomach or intestinal surgery or resection that would alter absorption and/or excretion of orally administered study drugs
History of alcoholism or drug addiction within 1 year prior to Check-in
History of chronic proton pump inhibitor (PPI) use within 6 months of Check-in, or use of PPIs, H2-receptor antagonists, or antacids within 1 month prior to Check-in and during the entire study
Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
History type 1 or 2 diabetes and/or elevated fasting glucose at baseline
Malabsorption syndrome or other condition that would interfere with enteral absorption
Use of any tobacco- or nicotine containing- products
Participation in any other investigational study drug or biologic agent trial in which receipt of an investigational study drug occurred within 5 half-lives or 30 days, whichever is longer to Check-in and during the entire study duration

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clinical Trials	Genentech, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Dallas	Texas	75247	United States

Intervention Browse Module

MeSH Terms

ID	Term
C582924	2-(3-(2-(1-isopropyl-3-methyl-1H-1,2-4-triazol-5-yl)-5,6-dihydrobenzo(f)imidazo(1,2-d)(1,4)oxazepin-9-yl)-1H-pyrazol-1-yl)-2-methylpropanamide
D017964	Itraconazole
D012293	Rifampin

Ancestor Terms

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

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