NCT04056455

A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys

A Phase 1 Pharmacokinetic Study of Oral Mobocertinib in Subjects With Severe Renal Impairment and Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 81 Years
• Healthy volunteers: Accepted

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.

Detailed 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 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.

Conditions

• Renal Impairment
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Mobocertinib	Mobocertinib capsule.

Timeline

• Start date: 2020-03-04
• Primary completion: 2022-04-20
• Completion: 2022-04-20
• First posted: 2019-08-14
• Last updated: 2024-01-08
• Results posted: 2024-01-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study