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

  • Healthy Volunteers
Trial Status:

Completed

This trial runs in
Countries
  • United Kingdom
Trial Identifier:

NCT02722018 2015-003730-27 GP29826

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial 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.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT02722018 , GP29826 , 2015-003730-27 Trial Identifier
      GDC-0810 Phase II Tablet, GDC-0810 Phase III Prototype Tablet Treatments
      Healthy Volunteer Condition
      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

      Eligibility Criteria

      Female Gender
      ≥ 40 Years & ≤ 70 Years Age
      Accepts Healthy Volunteers Healthy Volunteers
      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

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