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

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ClinicalTrials.gov Identifier: NCT01980953
Recruitment Status : Completed
First Posted : November 11, 2013
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: GDC-0032 Phase III Tablet Drug: GDC-0032 Tablet Drug: GDC-0032 Capsule Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Study Start Date : November 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: Food Effect
GDC-0032 will be administered orally over 3-Treatment Period (TP) in 6-sequence as one 3 milligrams (mg) capsule in TP-A after 10 hour fasting from food, one 3 mg Phase III tablet in TP-B after 10 hour fasting from food and one 3 mg Phase III tablet in TP-C following the start of standard Food and Drug Administration (FDA) high-fat breakfast. Washout period o 14 to 20 days will be given between each TP.
 Drug: GDC-0032 Phase III Tablet
Participants will receive 2 mg or 3 mg Phase III tablet after 10 hour fasting from food.

Drug: GDC-0032 Capsule
Participants will receive 3 mg GDC-0032 capsule formulation after 10 hour fasting from food.
Experimental: Part 2: Tablet Formulation Comparison
Different formulations of tablets (Tablet A and Tablet B) of GDC-0032 will be administered orally over 2-TP having 10 hour fasting from food. Participants will receive one 3 mg Tablet A in TP-A and one 3 mg Tablet B in TP-B after 14 to 20 days washout period.
 Drug: GDC-0032 Tablet
Participants will receive 3 mg Tablet A or Tablet B formulation after 10 hour fasting from food.
Experimental: Part 3: Capsule API Lot Comparison
Two different lots of GDC-0032 active pharmaceutical ingredient (API) capsule formulation will be administered orally in crossover fashion over 2-TP to 20 participants having 10 hour fasting from food. Participants will receive one 3 mg capsule in TP-A and one 3 mg capsule in TP-B after 14 to 20 days washout period.
 Drug: GDC-0032 Capsule
Participants will receive 3 mg GDC-0032 capsule formulation after 10 hour fasting from food.
Experimental: Part 4: Tablet Relative Bioavailibity
GDC-0032 will be administered orally in crossover fashion over 2-TP to 20 participants having 10 hour fasting from food. Participants will receive one 3 mg capsule in TP-A and one 2 mg Phase III tablet in TP-B after 14 to 20 days washout period.
 Drug: GDC-0032 Phase III Tablet
Participants will receive 2 mg or 3 mg Phase III tablet after 10 hour fasting from food.

Drug: GDC-0032 Capsule
Participants will receive 3 mg GDC-0032 capsule formulation after 10 hour fasting from food.


Outcome Measures
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Primary Outcome Measures :
  1. Area Under the Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC0-t) [ Time Frame: Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour post-dose ]
  2. Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-infinity) [ Time Frame: Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour post-dose ]
  3. Maximum Plasma Concentration (Cmax) [ Time Frame: Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour postdose ]

Secondary Outcome Measures :
  1. Time to Maximum Plasma Concentration (tmax) [ Time Frame: Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour post-dose ]
  2. Apparent Terminal Elimination Rate Constant [ Time Frame: Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour post-dose ]
  3. Apparent Terminal Elimination Constant (t1/2) [ Time Frame: Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour post-dose ]
  4. Apparent Total Clearance (CL/F) [ Time Frame: Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour post-dose ]
  5. Apparent Volume of Distribution (Vz/F) [ Time Frame: Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour post-dose ]
  6. Percentage of Participants With Adverse Events [ Time Frame: From Baseline up to approximately 15 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980953


Locations
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United States, Texas
Covance Research Unit - Dallas
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Genentech, Inc.
More Information
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01980953    
Other Study ID Numbers: GP28619
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017