Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis
End Stage Renal Disease on Hemodialysis
About this trial
This is an interventional treatment trial for End Stage Renal Disease on Hemodialysis focused on measuring Difelikefalin, Pharmacokinetics
Eligibility 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: Is surgically sterile; or Has been amenorrhoeic for at least 1 year and is over the age of 55 years; or 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.
Sites / Locations
- Investigator Site 1Recruiting
- Investigator Site 2Recruiting
- Investigator Site 3Recruiting
- Investigator Site 4Recruiting
Arms of the Study
Arm 1
Experimental
1-week, single arm, open label treatment phase