Treatment of hyperkalaemia MedDRA version: 21.1 Level: PT Classification code 10020646 Term: Hyperkalaemia System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Veltassa® (Patiromer)
Pharmaceutical Form: Powder for oral suspension
CAS Number: 1415477-49-4
Current Sponsor code: RLY5016
Other descriptive name: PATIROMER SORBITEX CALCIUM
Trade Name:
Sponsors
Vifor (International) Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male/female subject, = 25years; 2. Body Mass Index (BMI) between 18.5 and 35.0 kg/m2 inclusive; 3. Females of childbearing potential/ sexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices, diaphragm or condoms) for the duration of the trial and for 1 month after the last study drug administration; 4. Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhoea duration at least 12 months); 5. Values at sreening for the following tests must be: - Negative blood pregnancy test at screening and D-1; - Negative for hepatitis B surface antigen (HBsAg), antibody to hepatitis C (anti HCV), and antibody to human immunodeficiency virus (anti-HIV 1 and 2) at screening and D-1; - Negative drug screen (including alcohol breath test) at screening and D-1; 6. Willing to consume standard breakfast and adhere to the study conditions; 7. Able to understand the instructions and demonstrate ability to complete study questionnaire; 8. Considered as healthy after a comprehensive clinical assessment (detailed medical history, complete physical examination and laboratory evaluation); 9. Normal Blood Pressure (BP) and Heart Rate (HR) at the screening visit after 10 minutes in supine position: 95 mmHg = Systolic Blood Pressure (SBP) = 140 mmHg; 50 mmHg = Diastolic Blood Pressure (DBP) = 90 mmHg; 50 bpm = HR = 80 bpm; or considered non clinically significant (NCS) by investigators; 10. Normal ECG recording on a 12-lead ECG at the screening visit: 120 =65 years) yes F.1.3.1 Number of subjects for this age range 68
Exclusion criteria
Exclusion criteria: 1- A medical history including drugs that could impair their ability to see, smell and taste (see APPENDIX II); 2- A clinically significant medical history or laboratory finding not allowing the use of Patiromer and Sodium polystyrene sulfonate, eg hypokalaemia, hyper- and hypocalcaemia, hypomagnesaemia, kidney disease, liver disease, history of obstructive bowel disease, major gastrointestinal surgery; 3- Any structural or functional abnormality of the entire gastrointestinal tract incl. constipation or diarrhea and disturbances in swallowing; 4- History or presence of drug or alcohol abuse (alcohol consumption > 40 grams/ day); 5- Current smoking or smoking within the past 12 months incl. modern e-cigarettes exceeding 5 cigarettes/ day; 6- Subject has known sensitivity to any of the Investigational Medicinal Products to be administered; 8- Subject has previously entered this study; 9- Subject is currently enrolled in or has completed any other investigational device or drug study less than (<)30 days before screening, or is still receiving other investigational agent(s); 10- Subject is pregnant (e.g., positive human chorionic gonadotropin test) or breast feeding; 11- Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within two minutes of changing from supine to standing position; 12- Blood donation (including as part of a clinical trial) within 1 month before administration; 13- General anaesthesia within 1 month before administration; 14- Presence or history of drug hypersensitivity, especially against Kayexalate® and Veltassa®, or allergic disease diagnosed and treated by a physician; 15- Inability to abstain from intense muscular effort; 16- No possibility of contact in case of emergency; 17- Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests; 18- Positive results of screening for drugs of abuse; 19- Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development; 20- Exclusion period of a previous study; 21- Administrative or legal supervision; 22- Subject who would receive more than 4500 euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study; 23- Previous intake of commercially available Kayexalate® and Veltassa®; 24- Any employees of Vifor Pharma and Eurofins Optimed incl relatives; 25- Use of salt or electrolyte supplements containing sodium, potassium, calcium, phosphate formulations in the week before admission.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the overall acceptability of Patiromer with Sodium polystyrene sulfonate ;Secondary Objective: - Determine factors for non-positive acceptability (non-liking) - Determine the willingness for long-term use of Patiromer and Sodium polystyrene sulfonate. ;Primary end point(s): The overall acceptability score using a 9-points Hedonic Score (Cf. the Palatability questionnaire) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The proportion of subjects with positive ratings for overall acceptability, mixing appearance, smell, taste, mouth feel/texture/consistency, and aftertaste: Positive rating includes scores from 6 (“like slightly”) to 9 (“like extremely”) • The proportion of subjects with negative ratings for overall acceptability, mixing appearance, smell, taste, mouth feel/texture/consistency, and aftertaste: Negative rating includes scores from 4 (“dislike slightly”) to 1 (“dislike extremely”) • Determine the factors of non-positive palatability rating based on the scores from 4 (“dislike slightly”) to 1 (“dislike extremely”) | — |
Countries
France
Contacts
Public ContactPauline LEVEILLE
EUROFINS OPTIMED
Outcome results
None listed