Clinical trial NCT05885763: Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis
Official title: A Phase 1, Single-arm, Open-label Study to Evaluate the Pharmacokinetics and Safety of Intravenous Difelikefalin in Adult Chinese Subjects on Haemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: End Stage Renal Disease on Hemodialysis
Keywords: Difelikefalin
Pharmacokinetics
Lead sponsor: Vifor Fresenius Medical Care Renal Pharma
Sponsor class: INDUSTRY
Collaborators: name: Tigermed Consulting Co., Ltd
First posted: 2023-06-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A Single-arm, Open-label Study
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Total study duration for a single subject is up to 5 weeks including a screening period of up to 3 weeks, a treatment period of 1 week, and a safety follow-up period of 1 week.

The duration of PK sampling is 12 days.

The primary objective of the study is to evaluate the PK profile of a repeated (3 times weekly) dose of difelikefalin in Chinese HD subjects over a 1-week treatment period.

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:

  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.

Primary outcomes:
measure: Evaluation of the PK Profile of Difelikefalin - Cmax - Dose 1
timeFrame: 1 week
measure: Evaluation of the PK Profile of Difelikefalin - Tmax - Dose 1
timeFrame: 1 week
measure: Evaluation of the PK Profile of Difelikefalin - AUC0-t - Dose 1
timeFrame: 1 week
measure: AUCinf - Dose 1
timeFrame: 1 week
measure: AUCextrap(%) - Dose 1
timeFrame: 1 week
measure: t½ - Dose 1
timeFrame: 1 week
measure: Clearance - Dose 1
timeFrame: 1 week
measure: Vz - Dose 1
timeFrame: 1 week
measure: Evaluation of the PK Profile of Difelikefalin - Cmax - Dose 3
timeFrame: 1 week
measure: Evaluation of the PK Profile of Difelikefalin - Tmax - Dose 3
timeFrame: 1 week
measure: Evaluation of the PK Profile of Difelikefalin - AUC0-t - Dose 3
timeFrame: 1 week
measure: AUCinf - Dose 3
timeFrame: 1 week
measure: AUCextrap(%) - Dose 3
timeFrame: 1 week
measure: t½ - Dose 3
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigator Site 1
city: Beijing
country: China
facility: Investigator Site 2
city: Beijing
country: China
facility: Investigator Site 3
city: Shijiazhuang
country: China
facility: Investigator Site 4
Study officials:
affiliation: Vifor Pharma Group
name: Milica Enoiu, PhD
role: STUDY_DIRECTOR
References: