Healthy Volunteer
Conditions
Brief summary
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.
Interventions
DRUGGDC-0032 Phase III Tablet
Participants will receive 2 mg or 3 mg Phase III tablet after 10 hour fasting from food.
DRUGGDC-0032 Tablet
Participants will receive 3 mg Tablet A or Tablet B formulation after 10 hour fasting from food.
DRUGGDC-0032 Capsule
Participants will receive 3 mg GDC-0032 capsule formulation after 10 hour fasting from food.
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC0-t) | Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour post-dose |
| Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-infinity) | Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour post-dose |
| Maximum Plasma Concentration (Cmax) | Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour postdose |
Secondary
| Measure | Time frame |
|---|---|
| Apparent Terminal Elimination Constant (t1/2) | Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour post-dose |
| Time to Maximum Plasma Concentration (tmax) | Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour post-dose |
| Apparent Terminal Elimination Rate Constant | Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour post-dose |
| Apparent Total Clearance (CL/F) | Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour post-dose |
| Apparent Volume of Distribution (Vz/F) | Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour post-dose |
| Percentage of Participants With Adverse Events | From Baseline up to approximately 15 weeks |
Countries
United States
Outcome results
None listed