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 |
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.
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
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