A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 16
Summary
- Conditions
- Healthy Volunteers
- Renal Impairment
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 81 years
- Gender
- Both males and females
Description
The drug being tested in this study is called mobocertinib. This study is to assess the pharmacokinetic (PK) of mobocertinib and its active metabolites (AP32960 and AP32914) in participants with severe RI compared to matched-healthy participants with normal renal function. The study will enroll appr...
The drug being tested in this study is called mobocertinib. This study is to assess the pharmacokinetic (PK) of mobocertinib and its active metabolites (AP32960 and AP32914) in participants with severe RI compared to matched-healthy participants with normal renal function. The study will enroll approximately 24 participants. Participants will be assigned to 1 of the following 2 treatment groups: Severe RI: Mobocertinib 80 mg Normal Renal Function: Mobocertinib 80 mg Healthy participants with normal renal function will be recruited to match severe RI by age (mean plus or minus [+-] 10 years), gender (+-2 participants per gender), and body mass index (BMI), (mean +- 10 percent [%]). All participants will be asked to take single dose of mobocertinib on Day 1. This multi-center trial will be conducted in the United States. The overall time to participate in this study is 51 days. Participants will be contacted by telephone 30 days after the last dose of study drug for a follow-up assessment.
Tracking Information
- NCT #
- NCT04056455
- Collaborators
- Not Provided
- Investigators
- Study Director: Medical Director Millennium Pharmaceuticals, Inc.
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