MAD, Safety, PK&PD of multiple doses of CHN438 in adults & elderlies
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, multiple ascending dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of CHN438 in healthy adult and elderly subjects
IRAS ID
148598
Contact name
Annelize Koch
Contact email
Sponsor organisation
Novartis Institutes for Biomedical Research
Eudract number
2013-003436-77
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
CHN438 is being developed by the Sponsor, Novartis for the treatment of Alzheimer’s disease.
Alzheimer’s disease causes progressive mental deterioration that can occur in middle or old age. The mental deterioration is caused by generalised degeneration of the brain. It is the most common cause of premature senility. The study is divided into Part 1 (AFMPS/R&D/LSA/vcu 630983, EudraCT: 2013-003436-77, 03Jan2014) and Part 2. Separate groups of participants will be included in each part of the study. This application is intended for participants who will be included in Part 2.
This part (Part 2) of the study will recruit healthy, non smoking, males and females older than 65 years. Although approximately 112 participants will take part in the study (Parts 1 and 2), there will be approximately only 56 participants in this part (Part 2) of the study.
The main purpose of this study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate the pharmacokinetics (PK) of the study drug (how the study drug is taken up, metabolised [chemically broken down], distributed through the body and excreted). The study will also investigate the effects of the study drug on Amyloid β levels in the body.
Additional pharmacogenetic assessments and genotyping will also be done by using DNA testing. This is done to see if certain variation in DNA influences the way the study drug is taken up, metabolised, distributed through the body and excreted. The participants will be given an additional informed consent document to read and sign to give their permission to be part of this part of the study.
Vital signs, safety ECG measurements, safety laboratory assessments, adverse events and concomitant medications will be monitored throughout the entire investigational period. Plasma, urine and cerebrospinal fluid samples for pharmacokinetic analysis will be collected.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
14/EE/0065
Date of REC Opinion
21 Mar 2014
REC opinion
Further Information Favourable Opinion