A Study to Evaluate the Effect of a Proton-Pump Inhibitor (Rabeprazole) on the Relative Bioavailability of GDC 0973 in Healthy Subjects

Healthy Volunteer Clinical Trial

Official title:

A Phase 1, Open-Label, 3-Period, Randomized, Crossover Study to Evaluate the Effect of a Proton-Pump Inhibitor (Rabeprazole) on the Relative Bioavailability of GDC 0973 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01277718
• Other study ID #: MEK4954g
• Status: Completed
• Phase: Phase 1
• First received: January 7, 2011
• Last updated: February 23, 2011
• Start date: January 2011

Study information

• Verified date: February 2011
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1, single-center, open-label, randomized, 3-period, 2-sequence crossover study of GDC-0973 in healthy subjects to evaluate the effect of the proton pump inhibitor (PPI) rabeprazole on the relative bioavailability of GDC-0973 in healthy subjects when administered in the fed or fasted states.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria

• Within BMI range 18.5 to 29.9 kg/m2, inclusive

• In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs

• Clinical laboratory evaluations within the reference range for the test laboratory

• Negative test for selected drugs of abuse at Screening (does not include alcohol) and at each Check-in

• Negative hepatitis panel (including hepatitis B virus surface antigen [HBsAg] and hepatitis C virus antibody [anti-HCV]) and negative HIV antibody screens

• Healthy males and females of nonchildbearing potential who agree to use effective contraception

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 potentially alter absorption and/or excretion of orally administered drugs, except that appendectomy, hernia repair, and/or cholecystectomy will be allowed

• History or presence of an abnormal ECG

• History of alcoholism or drug addiction within 1 year prior to Period 1 Check-in

• Use of any tobacco- or nicotine-containing products within 6 months prior to Period 1 Check-in

• Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to Period 1 Check-in

• Use of any prescription medications/products within 14 days prior to Period 1 Check-in

• Use of any over-the-counter, non-prescription preparations within 7 days prior to Period 1 Check-in

• Use of alcohol-, grapefruit-, or caffeine-containing foods or beverages within 72 hours prior to Period 1 Check-in

• Poor peripheral venous access

• Any acute or chronic condition that would limit the subject's ability to complete and/or participate in this clinical study

• Female subject is pregnant, lactating, or breastfeeding

• Use of PPIs or histamine H2 receptor antagonists within 1 month prior to Period 1 Check-in

• Known hypersensitivity to rabeprazole or any of its components or to derived products of benzimidazoles

• Predisposing factors to retinal vein occlusion (RVO)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• GDC-0973/XL518
Oral dose in a fasted state
• GDC-0973/XL518
Oral dose in fed state
• rabeprazole
Repeating oral dose
• rabeprazole
Oral dose in fasted state

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under plasma concentration-time curve		8 weeks	No
Primary	Maximum observed concentration		8 weeks	No
Secondary	Incidence, nature, and severity of adverse events		8 weeks	No