ISRCTN11899726Active, not recruitingPhase 1
A Phase 1, open-label, single-dose study to evaluate the effect of moderate or severe renal impairment on the pharmacokinetics of inavolisib
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- F. Hoffmann-La Roche Ltd
- Enrollment
- 32
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Participants must have a body weight of at least 45 kilograms (kg), and a body mass index (BMI) within the range of 18 - 40 kilograms per square meter (kg/m2) (inclusive).
- •2. Negative hepatitis panel (hepatitis B virus core antibody, hepatitis B surface antigen, and hepatitis C virus antibody) and negative human immunodeficiency virus (HIV) antibody screens.
- •Additional inclusion criteria for participants with normal renal function:
- •1. Participants must be in reasonably good health for their age group.
- •2. Estimated glomerular filtration rate (eGFR) of 90 millilitres per minute (mL/min), as calculated using 2021 Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) creatinine equation at screening and confirmed at Day -1.
- •3. Matched to participants with renal impairment in sex, age (±10 years), and body weight (±15%).
- •Additional inclusion criteria for participants with moderate renal impairment:
- •1. Participants with moderate renal impairment must have eGFR 30-59 mL/min
- •2. Participants must have a stable renal function, defined as either:
- •2.1. If the time interval between Screening and Check-in (Day -1) is greater than 7 days, eGFR value on Day -1 is within 20% of eGFR value at Screening, or
- •2.2. If the time interval between Screening and Check-in (Day -1) is within 7 days, eGFR value on Day -1 is within 20% of eGFR value at Screening and there is no clinically significant change in eGFR over the past 3 months.
- •3. Stable medication regimen for at least 1 month prior to Check-in (Day -1)
- •Additional inclusion criteria for participants with severe renal impairment:
- •1. Participants with severe renal impairment must have eGFR <30 mL/min and not be on dialysis
- •2. Participants must have a stable renal function, defined as either:
- •2.1. If the time interval between Screening and Check-in (Day -1) is greater than 7 days, eGFR value on Day -1 is within 20% of eGFR value at Screening, or
- •2.2. If the time interval between Screening and Check-in (Day -1) is within 7 days, eGFR value on Day -1 is within 20% of eGFR value at Screening and there is no clinically significant change in eGFR over the past 3 months.
- •3. Stable medication regimen for at least 1 month prior to Check-in (Day -1).
Exclusion Criteria
- •1. History of Type 1 diabetes or Type 2 diabetes requiring ongoing systemic treatment with 2 or more agents
- •2. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder
- •3. Clinically significant and active liver disease, e.g., hepatitis, cirrhosis, or confirmed liver enzyme elevations.
- •4. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy and hernia repair will be allowed.
- •5. Malabsorption syndrome or other condition that would interfere with enteral absorption. This includes gastric bypass surgery; gastric band surgery is allowed.
- •6. History of active or latent tuberculosis (TB), regardless of treatment history, or positive QuantiFERON® TB Gold test.
- •Additional exclusion criteria for participants with normal renal function:
- •1. Significant history or clinical manifestation of renal injury or disease (as determined by the investigator).
- •2. Uncomplicated cholecystectomy more than 5 years prior to enrolment is allowed unless the participant was = 40 years old at the time of procedure; any cholecystectomy within 5 years of enrolment is exclusionary.
- •Additional exclusion criteria for participants with moderate and severe renal impairment:
- •1. Participants who have a functioning renal transplant or who are active on the transplant waiting list.
- •2. Blood potassium concentration <3 millimoles per litre (mmol/L) or >6 mmol/L at Screening
- •3. Hemoglobin concentration <9 grams per deciliter (g/dL) at Screening.
Investigators
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