A Double-blind, Randomized, Placebo-controlled, Pharmacokinetic, Safety, and Tolerability Study of CSL112 in adult subjects with Moderate Renal Impairment and in healthy adult subjects with Normal Renal Function.
We are looking for healthy adult subjects with Normal Renal Function.
Participants must meet the following criteria:
- You should weigh at least 50kg
- You cannot have you taken part in another clinical trial within the last 3 months
- You must be in good health and not suffer from any medical conditions
- You cannot be vegan or have any medical dietary restrictions
- You should not be pregnant or you should be willing to use an acceptable method of contraception during and 3 months after the study
There are other reasons why you may or may not qualify for this study. You can find out now if can take part by completing this short pre-screening form.
The drug being tested in this study is CSL112. This drug has the potential to treat patients with acute coronary syndrome (reduced blood into the heart muscle resulting in poor heart function or damage) and moderately poor kidney function.
Visit 1 – Screening
This will involve a doctor going through your medical history and a physical examination. You will have a number of tests during screening including vital signs (heart rate, blood pressure, respiratory rate and temperature), measurement of your height and weight, breath test (to measure for alcohol), blood and urine tests. An electrocardiogram (ECG) will check your heart function. This appointment determines your eligibility to take part in the trial.
Visit 2 – Admission – A single admission of 5 days and 4 nights.
You will be administered the study drug via an IV infusion following an overnight fast. Throughout the duration of your visit at set time points you will have a number of assessments including: measurement of your vital signs, ECGs, blood tests, urine tests, body weight and a physical examination. Your kidney function will be tested by injecting a substance, called iohexol, under your skin which will be present in different amounts in your urine and blood.
Visits 3 – 6 Outpatient visits
You will be required to attend the unit as an out-patient for additional blood tests, physical examination, body weight, ECGs, vital signs, and urine tests. On every visit you will be asked about any adverse events.
Visit 11 – Final follow up
We will repeat additional blood tests and ask about any adverse events.
Inpatient Stay: Saturday 7th November – Tuesday 10th November
Outpatient visit 1: Thursday 12th November
Outpatient Visit 2: Friday 13th November
Outpatient Visit 3: Sunday 15th November
Outpatient Visit 4: Sunday 22nd November
Final Follow Up: Sunday 17th January
Inpatient Stay: Tuesday 10th November – Saturday 14th November
Outpatient visit 1: Sunday 15th November
Outpatient Visit 2: Monday 16th November
Outpatient Visit 3: Wednesday 18th November
Outpatient Visit 4: Wednesday 25th November
Final Follow Up: Wednesday 20th January
Before every clinical trial, each medicine has undergone extensive laboratory testing, and every trial has to be approved by the MHRA (Medicine and Healthcare products Regulatory Agency) and an Independent Research Ethics Committee, who will evaluate and ensure the well-being of the volunteers is safeguarded.
The trials are such a valuable part of the process as they are stringently designed to guarantee the quality, reliability, and safety of new medicines.
In the last seven years, Quintiles Drug Research Unit at Guy’s Hospital has conducted over 1000 Phase 1 development studies worldwide. This has seen thousands of paid volunteers taking part in the trials, each making a hugely valuable contribution to medical research.
Quintiles Drug Research Unit at Guy’s Hospital is based in London and has over twenty years of Phase 1 clinical research experience in this unit, and this site alone has been involved in the testing of more than 200 potential new medicines.
If you would like to register to take part in a clinical trial at Quintiles Drug Research Unit at Guy’s Hospital you can do so via our secure online form.
By registering you are not making a commitment but simply expressing an interest to find out more. We will ask you a few more details about your health and will then discuss what studies you may be suitable for.
Studies will be approved by a recognized independent Research Ethics Committee.