A First-Time-in-Human Study to Assess the Safety and Tolerability of PP 1420 in Healthy Subjects
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A First Time in Human, Double Blind, Randomised, Placebo Controlled Dose Escalation Study to Assess the Safety and Tolerability of PP 1420 in Healthy Subjects.|
- Safety and tolerability: adverse events (AEs); change from baseline in clinical chemistry, haematology and urine parameters; change from baseline outside the normal range for BP, heart rate, 12-lead electrocardiogram (ECG) parameters as specified below. [ Time Frame: Within 7-10 days ] [ Designated as safety issue: Yes ]
- Pharmacokinetic parameters: AUC0-∞, AUC0-t, maximum observed plasma drug concentration (Cmax), time of maximum observed concentration (tmax), terminal elimination half-life (t½) and clearance. [ Time Frame: Within 7-10 days ] [ Designated as safety issue: No ]
- Relationship of drug exposure to safety/tolerability parameters: pharmacokinetics parameters and safety tolerability parameters including ECG (in particular QTc). [ Time Frame: Within 7-10 days ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Drug: PP 1420
More than 20 percent of people in the UK are obese. People with obesity have a shorter life expectancy, and have a higher risk of having heart attacks, strokes, high blood pressure, diabetes, and certain cancers.
At the moment, there is no treatment for obesity that is both effective and safe. Advising people to change their diet and to exercise more is frequently ineffective, and any loss in weight seen is usually temporary. There are a couple of licensed medications for the purpose of losing weight, but they are limited by side effects. Finally, gastric bypass and similar surgeries are effective at reducing weight permanently, but it can be risky and is restricted only to very motivated people.
"Gut hormones" are natural chemicals made by the bowels when you eat. They work to reduce appetite and hunger when you eat, so that you will eat enough for your needs. We think that one of the reasons why gastric bypass surgery is so effective is because the surgery causes an increase in gut hormone secretion into the bloodstream, which suppresses appetite. One of these hormones is pancreatic polypeptide (PP), which is released into the bloodstream by cells in the pancreas after eating. When human PP is given to healthy volunteers as an injection, we see that they have a reduced appetite and food intake with no side effects such as feeling sick or vomiting.
Human PP does not last long in the blood stream. In order to make it into a new, safe and effective drug for obesity, we have developed a new form of PP, which is very similar but not identical to human PP, that we expect will last longer in the blood. We call this PP 1420.
In testing, PP 1420 reduced food intake in animals, and was safe in them at much higher doses than those we plan to give in the current study. This study will assess the safety and tolerability of PP 1420 in humans, and is the first time humans have been given this medication.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052493
|Sir John McMichael Centre for Clinical Studies, Imperial College Healthcare NHS Trust|
|London, United Kingdom, W12 0NN|
|Principal Investigator:||Stephen Bloom, M.B. B.Chir. F.R.C.P. D.Sc.||Imperial College London|