LTR Pharma (ASX:LTP) started patient recruitment for the phase II pharmacokinetic trial of Spontan, an intranasal spray being developed to potentially treat erectile dysfunction, according to a Tuesday Australian bourse filing.
The study will assess single and multiple dose pharmacokinetics in about 27 healthy male participants across three groups, with around half aged 65 or older to meet US Food and Drug Administration geriatric-use guidance, the filing said.
The trial is designed to generate important prescribing insights for older men, a group that is frequently prescribed lower doses of oral phosphodiesterase type 5 inhibitors, such as Viagra and Cialis, per the filing.
Recruitment follows full regulatory approvals for the study, including clearance from the Human Research Ethics Committee at Bellberry and acceptance of the company's clinical trial notification by the Therapeutic Goods Administration, the filing added.