hase1 Ascending Single/Multiple Dose Study Lean/Overweight Subjects.
Research type
Research Study
Full title
ALB-127158(a) - A Phase I, Double Blind, Placebo Controlled Ascending Single and Multiple Oral Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male Lean and Overweight/Obese Subjects. Covance: 8225193
IRAS ID
56677
Contact name
Joseph Chiesa
Contact email
Sponsor organisation
Albany Molecular Research Inc
Eudract number
2010-020717-81
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
ALB127158(a) is a new drug which is intended to aid weight loss by inhibiting the effects of ??Melanin concentrating hormone?? (MCH).The purpose of this study is to assess how safe and well tolerated this drug is when given to healthy volunteers as both a single dose and as multiple doses given daily over 14 days. In addition part of this study has been designed to assess the effects of food on the absorption, breakdown and excretion of the drug. The study will also investigate how these parameters differ between lean and overweight subjects given the drug.The study has been divided into 3 parts (Parts 1 & 2 being single dose):Part 1 will comprise 18 lean male subjects divided into 2 groups of 9 subjects. Each group will take part in three alternating treatment periods with the dose ascending at each treatment period. In each treatment period 3 subjects will receive placebo. There will be a minimum of 20 days between dosing occasions (individual subjects) and 10 days between dose escalations.Part 2 will comprise 8 overweight male subjects. Each subject will take part in 2 treatment periods (one fasted, one fed) separated by at least 6 daysPart 3 will comprise 36 overweight male subjects divided into 3 groups of 12. All subjects will receive once daily dosing on Days 1 to 14 inclusive. 3 subjects in each group will receive placebo.After review of the data, further subjects or groups may be added and the IEC will be notified of the changes.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
10/IEC05/12
Date of REC Opinion
23 Jun 2010
REC opinion
Further Information Favourable Opinion