Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1, single-arm, open-label study to evaluate the safety, PK, and tolerability of a repeated (3 times weekly) dose of difelikefalin administered as IV bolus injections to adult Chinese HD subjects. Treatment period is one week and there is a safety follow-up period of 1 week.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vifor Fresenius Medical Care Renal Pharma
• Collaborator: Tigermed Consulting Co., Ltd

Criteria

Inclusion Criteria:

• End-stage renal disease (ESRD) subjects who have been on HD for at least 3 months before enrolment in the study and are currently on HD 3 times per week.

• Subjects with a prescription dry body weight between 40 and 100 kg, inclusive.

• If female, is not pregnant, or nursing

• If female:

1. Is surgically sterile; or

2. Has been amenorrhoeic for at least 1 year and is over the age of 55 years; or

3. Has a negative serum pregnancy test within 7 days before first dose of investigational product, and agrees to use adequate contraceptive precautions (e.g., hormonal contraceptives, barrier with spermicide, intrauterine device, vasectomised partner, or abstinence) from the time of informed consent until 7 days after the last dose of investigational product.

• If male, agrees not to donate sperm from the first dose of investigational product administration (Day 1) until 7 days after last dosing, and agrees to use a condom with spermicide or abstain from heterosexual intercourse during the study until 7 days after the last dose of investigational product.

Exclusion Criteria:

• Planned or anticipated to receive a kidney transplant during the study.

• Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) greater than 2.5 × the reference upper limit of normal (ULN), or bilirubin (total) greater than 4 × the ULN at screening.

• Subjects with severe hepatic impairment (Child-Pugh Class C).

• Known history of allergic reaction to opiates such as hives. Note: Side effects related to the use of opioids such as constipation or nausea would not exclude the subjects from the study.

• Subject has known hypersensitivity to the study intervention or any component of the investigational product formulation.