A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys
Condition: Renal Impairment; Healthy Volunteers
MeSH terms: Renal Insufficiency
Intervention: Mobocertinib
Intervention description: Mobocertinib capsule.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 81 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      It is hoped that mobocertinib will eventually help people with cancer with severely reduced
      kidney function. The main aim of this study is to learn about the levels of mobocertinib in
      the blood and urine of participants with severely reduced kidney function and participants
      with healthy kidneys. These participants do not have cancer. The information from this study
      will be used to work out the best dose of mobocertinib for people with cancer with severely
      reduced kidney function in the future.

      At the first visit, the study doctor will check who can take part. Participants who can take
      part will be placed into 1 of 2 treatment groups. Participants with severely reduced kidney
      function will be in 1 group. Participants with healthy kidneys will be in the other group.
      Participants in both groups will receive the same treatment and the group results will be
      compared.

      Participants from both groups will take 1 capsule of mobocertinib. They will stay in the
      clinic for 10 days so the study doctors can check the amount of mobocertinib in the blood and
      urine of these participants over time. The study doctors will also check if the participants
      have any side effects from this treatment.

      The clinic will call the participants 30 days after they took mobocertinib to check if they
      have any more side effects from their treatment.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion Criteria for Healthy Participants:

          1. Continuous non-smoker or moderate smoker (less than or equal to [<=] 10 cigarettes/day
             or the equivalent) before screening. Participant must agree to consume no more than 5
             cigarettes or equivalent/day from the 7 days prior to mobocertinib dosing and
             throughout the period of PK sample collection.

          2. Body mass index (BMI) greater than or equal to (>=) 18.0 and <=39.0 kilogram per
             square meter (kg/m^2), at screening. Participants will be matched to RI participants
             by BMI (mean +- 10%) at screening. At least 50% of the participants will be required
             to be of BMI >=18.0 and <=35.0 kg/m^2, at screening.

          3. Medically healthy with no clinically significant medical history, physical
             examination, laboratory profiles, vital signs or ECGs, as deemed by the Investigator
             or designee. Has liver function tests including alanine aminotransferase (ALT),
             Aspartate Aminotransferase (AST), Alkaline phosphatase (ALP), and total bilirubin
             within the upper limit of normal at screening and at check-in.

          4. Baseline estimated glomerular filtration rate (eGFR) >=90 milliliter per minute per
             1.73 square meter (mL/min/1.73 m^2) based on the Modification of Diet in Renal Disease
             (MDRD) equation at screening divided by standard body surface area (BSA) value of 1.73
             m^2. For participants with non-standard BSA, the eGFR value calculated by MDRD formula
             will be multiplied by the individual's BSA calculated using appropriate formula and
             divided by 1.73 m^2.

        Inclusion Criteria for Participants with RI:

          1. Continuous non-smoker or moderate smoker (<=10 cigarettes/day or the equivalent)
             before screening. Participant must agree to consume no more than 5 cigarettes or
             equivalent/day from the 7 days prior to dose of mobocertinib and throughout the period
             of PK sample collection.

          2. BMI >=18.0 and <=39.0 kg/m^2, at screening. At least 50% of the participants will be
             required to be of BMI >=18.0 and <=35.0 kg/m^2, at screening.

          3. Aside from RI, be sufficiently healthy for study participation based upon medical
             history, physical examination, vital signs, ECGs, and screening clinical laboratory
             profiles, as deemed by the Investigator or designee.

          4. Baseline eGFR 15-29 milliliter (mL) not on dialysis based on the MDRD equation at
             screening divided by standard BSA value of 1.73 m^2. For participants with
             non-standard BSA, the eGFR value calculated by MDRD formula will be multiplied by the
             individual's BSA calculated using appropriate formula and divided by 1.73 m^2.

          5. Has a diagnosis of chronic (greater than [>] 6 months), stable (no significant changes
             in renal function [less than [<] 30%] in the 30 days preceding screening; no acute
             episodes of illness within the previous 2 months due to deterioration in renal
             function) renal insufficiency. Participants with RI may have related medical
             conditions consistent with their disease (example, mild diabetes) that are stable for
             at least 3 months prior to screening, in the opinion of the Investigator or designee.

        Exclusion Criteria

          1. Positive results at screening for human immunodeficiency virus (HIV), Hepatitis B
             surface antigen (HBsAg), or hepatitis C virus (HCV).

          2. Positive test result for coronavirus disease 2019 (COVID-19) testing at screening or
             check-in.

          3. Seated heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at
             screening.

          4. Seated blood pressure is less than 90/40 millimeters of mercury (mmHg) or greater than
             180/100 mmHg at screening.

          5. Healthy participants: QT interval with Fridericia's correction (QTcF) interval is
             >=450 millisecond (msec) in males or >=470 msec in females or has ECG findings deemed
             abnormal with clinical significance by the Investigator or designee at screening

          6. RI participants: QTcF interval is >500 msec or has ECG findings deemed abnormal with
             clinical significance by the Investigator or designee at screening.

          7. Unable to refrain from or anticipates the use of any medication or substance
             (including prescription or over-the-counter, vitamin supplements, natural or herbal
             supplements) as indicated in (Prohibitions and Concomitant Medication) for the
             prohibited time period.

          8. Been on a diet incompatible with the on-study diet, in the opinion of the Investigator
             or designee, within the 30 days prior to dosing and throughout the study.

          9. Donation of blood or significant blood loss within 56 days prior to dosing.

         10. Plasma donation within 7 days prior to dosing.