ISRCTN60043317CompletedPhase 1
A phase 1, open-label, single-center study to investigate the absorption, metabolism, excretion, and absolute bioavailability of a single oral dose of [14C]-labeled inavolisib and an iv tracer dose of [13C6]-labeled inavolisib in a single cohort of healthy volunteers
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Genentech, Inc
- Enrollment
- 8
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Males, who are sterile, and females of non-childbearing potential
- •2. Aged between 18 and 65 years, inclusive
- •3. =3 male volunteers
- •4. Body mass index (BMI) between 18.5 and 32.0 kg/m², inclusive
- •5. In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs, and taking no chronic medications
- •6. Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator. Evaluations will include a chemistry panel (fasted at least 8 h), complete blood count, coagulation testing (including prothrombin time, international normalized ratio, and activated partial thromboplastin time), and urinalysis with complete microscopic analysis, and glycosylated hemoglobin.
- •7. Negative test for selected drugs of abuse (does not include alcohol) at screening visit and day -1 (including alcohol)
- •8. Negative hepatitis panel (hepatitis B surface antigen and hepatitis C virus antibody) and negative human immunodeficiency virus (HIV) antibody screens
- •9. Negative screening test for latent mycobacterium tuberculosis (TB) infection using QuantiFERON® TB Gold
- •10. Receive an explanation of the mandatory WGS component of the study
- •11. Able to comprehend and willing to sign an Informed Consent Form (ICF)
- •12. History of =1 bowel movement per day
- •13. Male volunteers: sterile by history for at least 90 days prior to dosing, including volunteers who are sterile due to vasectomy, bilateral orchiectomy, other surgical procedure, or known sterilizing medical condition. Male volunteers should use a barrier method such as a condom with any female partner of child-bearing potential and with any pregnant partner for 90 days after dosing.
Exclusion Criteria
- •1. History of type 1 diabetes or type 2 diabetes requiring systemic treatment
- •2. More than 1 of the following risk factors
- •2.1. BMI >32.0 kg/m²
- •2.2. Fasting blood glucose=125 mg/dl (7.0 mmol/l)
- •2.3. Glycosylated hemoglobin (HbA1C) =6.5%
- •3. Have a PR interval >210 ms, QRS complex >120 ms, or QTc interval >450 ms for males, >470 ms for females
- •4. History or presence of an abnormal ECG that, in the Investigator’s opinion, is clinically significant
- •5. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the Investigator)
- •6. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator
- •7. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs with the exception of appendectomy and hernia repair surgery
- •8. History of inflammatory bowel disease (such as Crohn’s disease or ulcerative colitis), or active bowel inflammation (such as diverticulitis, with the exception of inactive diverticulosis)
- •9. History of ocular or intraocular conditions (such as cataract or diabetic retinopathy), active vitritis, history of or active uveitis, or active infections in the eye
- •10. History of alcoholism or drug addiction within 1 year prior to day -1
- •11. History of active or latent TB, regardless of treatment history
- •12. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives of the investigational agent or 30 days before screening whichever is longer
- •13. Receipt of the first or second dose of a Coronavirus Disease 2019 (COVID-19) vaccine given Emergency Use Approvals (US) or approved COVID-19 vaccine in the past 7 days prior to dosing or planned to receive any COVID-19 vaccines during the trial
- •14. History of active viral, bacterial, or fungal infection requiring IV treatment with antibiotics within 14 days prior to day -1
- •15. Use of any immunosuppressive therapies within 8 weeks prior to the Screening evaluation
- •16. Use of any prescription medications/products within 14 days prior to day -1, unless deemed acceptable by the Investigator
- •17. Use of any over-the-counter, non-prescription preparations (including vitamins; minerals; and phytotherapeutic-, herbal-, and plant-derived preparations) within 7 days prior to day -1, unless deemed acceptable by the Investigator
- •18. Use of any drugs known to be strong inhibitors or inducers of cytochrome P450 (CYP)3A, from within 30 days prior to day -1 until Study Completion
- •19. Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) from within 6 months prior to day -1 until Study Completion
- •20. Use of alcohol-, grapefruit-, or caffeine-containing foods or beverages from within 72 h prior to day -1
Investigators
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