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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01980953
• Other study ID #: GP28619
• Status: Completed
• Phase: Phase 1
• First received: November 5, 2013
• Last updated: January 31, 2017
• Start date: November 2013
• Est. completion date: July 2014

Study information

• Verified date: January 2017
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• GDC-0032 Phase III Tablet
Participants will receive 2 mg or 3 mg Phase III tablet after 10 hour fasting from food.
• GDC-0032 Tablet
Participants will receive 3 mg Tablet A or Tablet B formulation after 10 hour fasting from food.
• GDC-0032 Capsule
Participants will receive 3 mg GDC-0032 capsule formulation after 10 hour fasting from food.

Locations

Country	Name	City	State
United States	Covance Research Unit - Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of Participants With Adverse Events		From Baseline up to approximately 15 weeks