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

Sponsor

Genentech, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01814709

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: GDC-0032 Drug: Itraconazole Drug: Rifampin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

A Phase 1, Open-Label Study to Evaluate the Effect of Rifampin or Itraconazole on the Pharmacokinetics of GDC-0032 in Healthy Subjects

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Itraconazole Arm	Drug: GDC-0032 Oral doses of GDC-0032 Drug: Itraconazole Oral doses of Itraconazole
Experimental: Rifampin Arm	Drug: GDC-0032 Oral doses of GDC-0032 Drug: Rifampin Oral doses of Rifampin

Arm

Intervention/Treatment

Experimental: Itraconazole Arm

Drug: GDC-0032

Oral doses of GDC-0032

Drug: Itraconazole

Oral doses of Itraconazole

Experimental: Rifampin Arm

Drug: GDC-0032

Oral doses of GDC-0032

Drug: Rifampin

Oral doses of Rifampin

Outcome Measures

Primary Outcome Measures

Pharmacokinetics: Plasma concentrations of GDC-0032 [2 months]
Safety: Incidence of adverse events [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Dallas	Texas	United States	75247

Sponsors and Collaborators

Genentech, Inc.

Investigators

Study Director: Clinical Trials, Genentech, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Genentech, Inc.

ClinicalTrials.gov Identifier:

NCT01814709

Other Study ID Numbers:

GP28617

First Posted:

Mar 20, 2013

Last Update Posted:

Nov 2, 2016

Last Verified:

Nov 1, 2016

Additional relevant MeSH terms:

Itraconazole

Rifampin

Study Results

No Results Posted as of Nov 2, 2016