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

NCT01814709 | Completed Phase 1

• 1 other identifier: GP28617
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics: Plasma concentrations of GDC-0032

  2 months

• Safety: Incidence of adverse events

  2 months

Study Arms (2)

Itraconazole Arm

EXPERIMENTAL

Drug: GDC-0032; Drug: Itraconazole

Rifampin Arm

EXPERIMENTAL

Drug: GDC-0032; Drug: Rifampin

Interventions

GDC-0032 DRUG

Oral doses of GDC-0032

Itraconazole Arm; Rifampin Arm

Itraconazole DRUG

Oral doses of Itraconazole

Itraconazole Arm

Rifampin DRUG

Oral doses of Rifampin

Rifampin Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (1)

Unknown Facility

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

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; Itraconazole; Rifampin

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 20, 2013
• Study Start: April 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)