Safety, pharmacokinetics and quantitative EEG modulation of TAK-071, a novel muscarinic M1 receptor positive allosteric modulator, in healthy subjects.

ABSTRACT:

Aims

TAK-071 is a muscarinic M₁ receptor positive allosteric modulator designed to have low cooperativity with acetylcholine. This was a first-in-human study to evaluate the safety, pharmacokinetics, and pharmacodynamics of TAK-071.

Methods

TAK-071 was administered as single and multiple doses in a randomized, double-blind, placebo-controlled, parallel-group design in healthy volunteers alone and in combination with donepezil. Laboratory, electrocardiogram (ECG) and electroencephalogram (EEG) evaluations were performed. Cerebrospinal fluid and blood samples were taken to evaluate the pharmacokinetics (PK), relative bioavailability and food effect.

Results

TAK-071 was safe and well tolerated, and no deaths or serious adverse events occurred. TAK-071 demonstr

SUBMITTER: Yin W 

PROVIDER: S-EPMC9291057 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature