Ignite Creation Date:
2024-05-06 @ 12:12 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01515319
Status:
COMPLETED
Last Update Posted:
2021-02-08
First Post:
2011-12-22
Brief Title:
Safety and Pharmacokinetic Study of Y242 in Adult Subjects
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
A Randomised Placebo Controlled Study to Investigate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Y242 in Adult Subjects
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Y242-01
Brief Summary:
Obesity causes 600 premature deaths per week in the UK and existing treatments are not effective When humans eat the bowels naturally secrete chemicals into the bloodstream which make people feel full and which stop eating One of these chemicals is known as Peptide YY PYY The investigators have previously shown that injections of PYY reduce appetite and food intake in human volunteers The investigators have now developed a very similar chemical Y242 as a treatment for obesity Y242 has been tested in animals and has been shown to be safe to reduce their appetite and to last for much longer than PYY itself This study will test Y242 to ensure that it is well tolerated in humans and to see how long it lasts in the blood stream after being injected under the skin It will also look for any effects on appetite
Detailed Description:
Obesity causes 600 premature deaths per week in the UK and existing treatments are less than ideal Intravenous infusion of a hormone called PYY reduces food intake but its effects only last for a few hours and it can cause nausea Y242 is a longacting analogue of PYY Given subcutaneously in rodents it has a profile of action of at least 72 hours and strongly inhibits food intake It causes weight loss without behavioural effects With MRC funding Y242 has passed Good Laboratory Practice toxicology testing and the present proposal is a first in human study to investigate its safety tolerability and pharmacokinetics in overweight but otherwise healthy men
The study is a combined single ascending dose part A and multiple ascending dose part B Phase 1 investigation The primary objective is to investigate safety and tolerability The secondary objective is to assess Y242s pharmacokinetic PK profile Possible effects on food consumption will be explored For part A up to 48 subjects are planned with up to 40 subjects for part B In each part subjects are divided into groups each of which is dosed with the same level starting with a single dose part A much lower than is expected to cause an effect Subjects are admitted to a Unit so they can be closely observed for adverse effects and safety tests blood concentrations of the drug and food and liquid intake and output will be monitored Subjects are allocated at random like tossing a coin to receive Y242 or placebo dummy Safety tolerability and pharmacokinetic data will be summarised and available results considered in deciding dose escalation with stopping rules designed to enable us to explore the relationship between dose and adverse effect eg nausea without causing unacceptable nausea or other symptoms in the volunteers
The study is a combined single ascending dose part A and multiple ascending dose part B Phase 1 investigation The primary objective is to investigate safety and tolerability The secondary objective is to assess Y242s pharmacokinetic PK profile Possible effects on food consumption will be explored For part A up to 48 subjects are planned with up to 40 subjects for part B In each part subjects are divided into groups each of which is dosed with the same level starting with a single dose part A much lower than is expected to cause an effect Subjects are admitted to a Unit so they can be closely observed for adverse effects and safety tests blood concentrations of the drug and food and liquid intake and output will be monitored Subjects are allocated at random like tossing a coin to receive Y242 or placebo dummy Safety tolerability and pharmacokinetic data will be summarised and available results considered in deciding dose escalation with stopping rules designed to enable us to explore the relationship between dose and adverse effect eg nausea without causing unacceptable nausea or other symptoms in the volunteers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-003549-17 | EUDRACT_NUMBER | None | None |