An Absolute Bioavailability Study in Healthy Subjects Comparing Oral to Intravenous Administration of GDC-0973

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Single Dose, Randomized, Cross-over Absolute Bioavailability Study in Healthy Subjects Comparing Oral to Intravenous Administration of GDC-0973

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01249118
• Other study ID #: MEK4952g
• Status: Completed
• Phase: Phase 1
• First received: November 24, 2010
• Last updated: August 16, 2013
• Start date: November 2010

Study information

• Verified date: August 2013
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of Part 1 of this study is to evaluate the safety and tolerability of the intravenous (IV) dose of GDC-0973. The primary objectives of Part 2 of this study are to evaluate the absolute bioavailability of GDC-0973 and to evaluate the pharmacokinetic (PK) of GDC-0973 following IV and oral administration. The secondary objective of Part 2 of this study is to evaluate the safety of GDC-0973 administered orally and intravenously.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria

• Within body mass index (BMI) range 18.5 to 29.9 kg/m2

• In good health, determined by no clinically significant findings from medical history

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

• Negative test for selected drugs of abuse at Screening and at each Check-in

• Negative hepatitis panel and anti-hepatitis C virus and negative HIV antibody screens

• Healthy males and females of non-child-bearing potential or 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 cholecystectomy will be allowed

• History or presence of an abnormal electrocardiogram (ECG)

• History of alcoholism or drug addiction prior to study start

• Use of any tobacco-containing or nicotine-containing products prior to study start

• Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 28 days or 5 half-lives, whichever is longer, prior to study start

• Use of any prescription medications/products, including proton pump inhibitors, within 14 days prior to study start

• 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

• Predisposing factors to retinal vein occlusion (RVO)

Study Design

Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• GDC-0973/XL518
Each subject will receive a single IV dose and oral dose separated by 10 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameters of GDC-0973 (including total exposure, maximum and minimum serum concentration, clearance, volume of distribution at steady state, absolute bioavailability)		Following administration of study drug	No
Primary	Incidence, nature, and severity of adverse events and serious adverse events		Through study completion or early study discontinuation	No