A study to assess the effects of AZD9977 single dose on healthy males
Research type
Research Study
Full title
A phase 1, randomized, single-blind, placebo-controlled study to assess the safety, tolerability and pharmacokinetics of AZD9977 following single ascending dose administration to healthy male subjects
IRAS ID
181280
Contact name
Muna Albayaty
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2015-000877-11
Duration of Study in the UK
0 years, 4 months, 4 days
Research summary
This is a Phase 1 study to investigate the safety and tolerability of a new drug, AZD9977. The results from this study will form the basis of future studies. This is the first time AZD9977 will be given tohumans, and up to 92 healthy male subjects will be randomised in this study. This study will take place in Part A and Part B. In Part A we will study the safety, tolerability and pharmacokinetics (how the body absorbs, metabolizes and excretes AZD997) of the study drug, while in Part B we will study the regional absorption of the study drug in the digestive system.
Part A is Single-Blind and makes use of a placebo to facilitate identification of the effects of the study drug.
Part B will make use of the IntelliCap programmable capsule, which will be loaded with a suspension of the study drug before being swallowed by the subjects. The capsule will be programmed to release controlled doses of the study drug at certain areas of the digestive tract, in order to study the effects of regional absorption. The capsule will be excreted from the subjects digestive tract after the study and returned to the study center.REC name
London - Brent Research Ethics Committee
REC reference
15/LO/0612
Date of REC Opinion
2 Jun 2015
REC opinion
Further Information Favourable Opinion