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Study to Investigate the Effect of Formulation and Food on the Pharmacokinetics of GDC-0810

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ClinicalTrials.gov Identifier: NCT02722018
Recruitment Status : Completed
First Posted : March 29, 2016
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This is a phase 1, randomized, open-label, single center, crossover study to investigate the effect of formulation and food on the pharmacokinetics of GDC-0810 in female healthy participants of non-childbearing potential. This study is divided into three parts. Participants in each part will be randomized to one of three treatment sequences. Part 1 study in 4 periods will investigate the effect of formulation on the pharmacokinetics (PK) of GDC-0810 administered with low-fat food. Each participant in this part will receive a single dose of GDC-0810 dose level A following consumption of a low fat meal (30 minutes after the start of the meal) in each treatment period. Part 2 is an optional Phase I study in 3 periods to investigate the effect of formulation on the PK of GDC-0810 administered with low-fat food in healthy female participants of non-childbearing potential. Part 3 study in three periods will compare the PK of a Phase III prototype tablet formulation selected from Parts 1 and 2 of the study with the Phase II tablet formulation (both administered 30 minutes after the start of a low fat meal) at dose level B and to investigate the PK of the Phase III prototype formulation administered in the fasted state.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: GDC-0810 Phase II Tablet Drug: GDC-0810 Phase III Prototype Tablet Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Open-Label, Single Center Study to Investigate the Effect of Formulation and Food on the Pharmacokinetics of GDC-0810 in Female Healthy Subjects on Non-Childbearing Potential
Actual Study Start Date : January 6, 2016
Actual Primary Completion Date : September 13, 2016
Actual Study Completion Date : September 13, 2016

Arm Intervention/treatment
Experimental: Part 1: GDC-0810 dose level A - Low Fat Meal
Participants will receive a single dose of GDC-0810 dose level A on Day 1 of each treatment period. GDC-0810 will be administered with low fat meal in the form of Phase II tablet or one of three Phase III prototype tablets (Prototype 1, 2 or 3) in a crossover fashion.
Drug: GDC-0810 Phase II Tablet
Participants will receive dose level A (in Parts 1 and 2) or dose level B (in Part 3) tablets.

Drug: GDC-0810 Phase III Prototype Tablet
Participants will receive dose level A (in Parts 1 and 2) or dose level B (in Part 3) tablets.

Experimental: Part 2 (Optional): GDC-0810 dose level A - Low Fat Meal
Participants will receive a single dose of GDC-0810 dose level A on Day 1 of each treatment period. GDC-0810 will be administered with low fat meal in the form of Phase II tablet or one of two Phase III prototype tablets (Prototype 4 or 5) in a crossover fashion.
Drug: GDC-0810 Phase II Tablet
Participants will receive dose level A (in Parts 1 and 2) or dose level B (in Part 3) tablets.

Drug: GDC-0810 Phase III Prototype Tablet
Participants will receive dose level A (in Parts 1 and 2) or dose level B (in Part 3) tablets.

Experimental: Part 3: GDC-0810 dose level B - Low Fat Meal/Fasted
Participants will receive a single dose of GDC-0810 dose level B on Day 1 of each treatment period. GDC-0810 will be administered with low fat meal or under fasted condition either as Phase II tablet (with low fat meal) or as the Phase III prototype tablet selected from Parts 1 or 2 (with low fat meal or under fasted conditions), in a crossover fashion.
Drug: GDC-0810 Phase II Tablet
Participants will receive dose level A (in Parts 1 and 2) or dose level B (in Part 3) tablets.

Drug: GDC-0810 Phase III Prototype Tablet
Participants will receive dose level A (in Parts 1 and 2) or dose level B (in Part 3) tablets.




Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of GDC-0810 [ Time Frame: Pre-dose (1 hour before dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16 hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3) of each treatment period ]
  2. Time to Reach Cmax (Tmax) of GDC-0810 [ Time Frame: Pre-dose (1 hour before dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16 hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3) of each treatment period ]
  3. Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of GDC-0810 [ Time Frame: Pre-dose (1 hour before dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16 hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3) of each treatment period ]
  4. Area Under the Plasma Concentration Versus Time Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of GDC-0810 [ Time Frame: Pre-dose (1 hour before dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16 hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3) of each treatment period ]
  5. Apparent Terminal Elimination Rate Constant (lambda Z) of GDC-0810 [ Time Frame: Pre-dose (1 hour before dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16 hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3) of each treatment period ]
  6. Apparent Terminal Elimination Half-Life (t1/2) of GDC-0810 [ Time Frame: Pre-dose (1 hour before dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16 hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3) of each treatment period ]
  7. Apparent Oral Clearance (CL/F) of GDC-0810 [ Time Frame: Pre-dose (1 hour before dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16 hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3) of each treatment period ]
  8. Apparent Volume of Distribution (Vz/F) of GDC-0810 [ Time Frame: Pre-dose (1 hour before dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16 hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3) of each treatment period ]
  9. Relative Bioavailability Based on Cmax (Frel Cmax) of GDC-0810 (Test vs Reference) [ Time Frame: Pre-dose (1 hour before dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16 hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3) of each treatment period ]
  10. Relative Bioavailability Based on AUC0-t (Frel AUC0-t) of GDC-0810 (Test vs Reference) [ Time Frame: Pre-dose (1 hour before dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16 hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3) of each treatment period ]
  11. Relative Bioavailability Based on Cmax (Frel Cmax) of GDC-0810 (Fed vs Fasted) [ Time Frame: Pre-dose (1 hour before dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16 hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3) of each treatment period ]
  12. Relative Bioavailability Based on AUC0-t (Frel AUC0-t) of GDC-0810 (Fed vs Fasted) [ Time Frame: Pre-dose (1 hour before dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16 hours post-dose on Day 1, 24 and 36 hours post-dose (Day 2), 48 hours post-dose (Day 3) of each treatment period ]

Secondary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to 28 days after last GDC-0810 dose (Up to 57 days) ]


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female participants of non-childbearing potential including non-pregnant, non-lactating, and either postmenopausal or surgically sterile for at least 45 days post procedure
  • Body mass index (BMI) range 18.0 to 32.0 kilograms per square meter (kg/m^2), inclusive
  • In good health, as determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs, and clinical laboratory evaluations
  • Receive an explanation of the mandatory pharmacogenomics (PgX) component of the study

Exclusion Criteria:

  • Any history of endometrial polyps, endometrial cancer, atypical endometrial hyperplasia, or other endometrial disorders unless subjects have undergone total hysterectomy and there is no evidence of active disease
  • Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
  • History of any thrombophilic condition, inflammatory bowel disease, active bowel inflammation, chronic diarrhea, short bowel syndrome, and upper gastro-intestinal (GI) surgery including gastric resection
  • Any history of venous thrombosis (including pulmonary embolism [PE])
  • Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 90 days prior to Check-in (Day -1) in Period 1
  • Use of systemic hormone replacement therapy within 1 year prior to Check-in (Day -1)
  • History of use of tamoxifen, aromatase inhibitors, or any other endocrine agent for the treatment of breast cancer

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): NCT02722018


Locations
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United Kingdom
Quotient Clinical Ltd, Clinical Research Unit
Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02722018     History of Changes
Other Study ID Numbers: GP29826
2015-003730-27 ( EudraCT Number )
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017