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Completed

NCT Number: NCT01814709

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GDC-0032

Drug

Oral doses of GDC-0032

Itraconazole

Drug

Oral doses of Itraconazole

Rifampin

Drug

Oral doses of Rifampin

Primary outcomes

  1. Pharmacokinetics: Plasma concentrations of GDC-0032

    Time frame: 2 months

  2. Safety: Incidence of adverse events

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 20, 2013
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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