PK,PD & Safety Trial of CAM2047, CAM2048 & CAM2058 in Healthy Subjects
Research type
Research Study
Full title
A Phase 1, Randomised, Open-Label Trial Assessing Pharmacokinetics, Pharmacodynamics and Safety of Single Subcutaneous Doses of CAM2047 (Granisetron FluidCrystal® Subcutaneous Injection Depot), CAM2048 (Buprenorphine FluidCrystal® Subcutaneous Injection Depot), and CAM2058 (Granisetron/Buprenorphine FluidCrystal® Subcutaneous Injection Depot), and Single Intravenous Doses of Granisetron and Buprenorphine in Healthy Volunteers
IRAS ID
211714
Contact name
Muna Albayaty
Contact email
Sponsor organisation
Camurus AB
Eudract number
2016-002574-13
Duration of Study in the UK
0 years, 6 months, 13 days
Research summary
This is a randomised, open-label clinical trial to investigate the pharmacokinetics (PK), pharmacodynamics (PD) and safety of single subcutaneous (SC) doses of the study medications: CAM2047 (Granisetron FluidCrystal® Subcutaneous Injection Depot), CAM2048 (Buprenorphine FluidCrystal® Subcutaneous Injection Depot), and CAM2058 (Granisetron/Buprenorphine FluidCrystal® Subcutaneous Injection Depot), and the single intravenous doses of the reference products Granisetron and Buprenorphine (Granisetron® Temgesic®) in healthy male and female subjects between the ages of 18 and 65 years.
Subjects will be randomised into 3 cohorts, with 3 groups per cohort and 15 subjects per group, therefore approximately 135 subjects will take part in the study. Subjects will participate in one treatment sequence only. For each subject the study will comprise of a screening visit, a treatment period (including 1 or 2 in house periods), ambulatory visits and a follow up visit after the last dose of the study medications are administered.
The study medication (CAM2058) being developed, is a combination product between CAM2048 and CAM2047. CAM2048 is a long-acting formulation of buprenorphine that is being developed as ready-to-use product for the treatment of moderate to severe pain. CAM2047 is a novel, long-acting formulation of granisetron that is being developed as a ready to use product for the prevention of acute and delayed chemotherapy induced nausea and vomiting and to reduce the incidence of post-operative nausea and vomiting (PONV). The combination study medication (CAM2058) is being developed as a single-injection immediately before surgery for providing pain relief, while avoiding PONV, as well as buprenorphine associated nausea and vomiting.
The main purpose of the study is to investigate how the study medications are absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body). As a result, blood samples for PK analysis will be collected. The study will also see how safe the study medications are after single doses were taken. Vital signs, local tolerability assessments, safety electrocardiogram (ECG) measurements, safety laboratory assessments, pulse oximetry, adverse events and concomitant medications will be monitored throughout the entire investigational period.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
16/SC/0403
Date of REC Opinion
16 Sep 2016
REC opinion
Favourable Opinion