A Study to Evaluate the Effect of Particle Size, Formulation and Food on the Pharmacokinetics of GDC-0032 in Healthy Volunteers



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:2/2/2017
Start Date:November 2013
End Date:July 2014

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A Phase 1, Open-Label Study to Evaluate the Effect of Particle Size, Formulation, and Food on the Pharmacokinetics of GDC-0032 in Healthy Subjects

This 4-part study will assess the effect of formulation, food, and active pharmaceutical
ingredient (API) lot on the pharmacokinetics of GDC-0032 in healthy volunteers. Part 1 is an
open-label, 3-period, 6-sequence study, and Parts 2, 3, and 4 are open-label 2-period
crossover studies. Participants will receive single doses of GDC-0032 capsule or tablet
formulation, in the fasted or fed state.


Inclusion Criteria:

- Males or females of non-childbearing potential, between 18 and 55 years of age,
inclusive; females will meet the following criteria: they will be non-pregnant,
non-lactating, and either postmenopausal for at least 1 year or surgically sterile
for at least 90 days.

- Body mass index (BMI) 18.5 to 32 kg/m^2, inclusive

- In good health, determined by no clinically significant findings from medical
history, 12-lead electrocardiogram (ECG), vital signs and clinical laboratory
evaluations

- Negative test for selected drugs of abuse at Screening (does not include alcohol) and
at each Check-in (Day -1; does include alcohol)

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

- Males will either be sterile or agree to use approved methods of contraception as
defined by protocol from Period 1 Check-in (Period 1, Day -1) until 90 days following
the last dose of study drug

Exclusion Criteria:

- Significant history or clinical manifestation of any metabolic, allergic,
dermatological, hepatic, renal, hematological, pulmonary, cardiovascular,
gastrointestinal, neurological, or psychiatric disorder (as determined by the
Investigator)

- History of significant hypersensitivity, intolerance, or allergy to any drug
compound, food, or other substance, unless approved by the Investigator

- History of stomach or intestinal surgery or resection that would potentially alter
absorption and/or excretion of orally administered drugs, except for appendectomy,
hernia repair, and/or cholecystectomy

- History of alcoholism or drug addiction within 1 year prior to Period 1 Check-in
(Period 1, Day -1)

- Clinically significant history of liver disease, including viral or other hepatitis,
current alcohol abuse, or cirrhosis

- History of Type 1 or 2 diabetes mellitus and/or elevated fasting glucose (greater
than [>] 120 milligrams per deciliter [mg/dL]) at baseline (as confirmed by repeat)

- History of Gilbert's Syndrome

- Evidence of malabsorption syndrome or other condition that would interfere with
enteral absorption

- Inability or unwillingness to swallow pills or consume high-fat breakfast

- Use of any tobacco- or nicotine-containing products within 6 months prior to Period 1
Check-in (Period 1, Day -1) and during the entire study

- Participation in any other investigational study drug trial in which receipt of an
investigational study drug occurred within 5 half-lives or 30 days, whichever is
longer, prior to Period 1 Check-in (Period 1, Day -1) and during the entire study
duration
We found this trial at
1
site
1341 West Mockingbird Lane
Dallas, Texas 75247
?
mi
from
Dallas, TX
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