Evaluating the Safety, Tolerability, and Pharmacodynamic Properties of IW-6463 in Healthy Elderly Subjects

C6463-102

This is a randomized, double-blind, placebo-controlled, 2-way cross-over study in healthy male and female elderly participants.

2020-01-06

2020-05-22

2020-05-22

Terminated

Early phase I

24

Inclusion Criteria: * Subject is an ambulatory adult at least 65 years old at the screening visit * Subject is in good health and has no clinically significant findings on physical examination * Female participants must be postmenopausal. A postmenopausal state is defined as no menses for ≥12 consecutive months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level at screening (\>40 IU/L or mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state. * Male participants who have not been surgically sterilized by vasectomy (conducted ≥60 days before the Screening Visit or confirmed via sperm analysis) must agree contraceptive use per protocol * Men must also agree to not donate sperm throughout the study and for 3 months after the final dose of study drug * Other inclusion criteria per protocol Exclusion Criteria: * Any active or unstable clinically significant medical condition * Other exclusion criteria per protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

2023-10-17