Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT03964558
Brief Summary:
This is a single-centre, open-label, non-randomised, single oral dose study in healthy male subjects. It is planned to enroll and dose 6 subjects. Subjects will be admitted to the clinical unit on the evening of Day 1 prior to investigational medicinal product (IMP) administration. Subjects will be dosed on the morning of Day 1 and it is planned that they will remain resident in the clinic until up to 168 hour after dosing (up to Day 8). It is planned that subjects will be released as a group when all subjects have achieved a mass balance cumulative recovery of \>90% or if \<1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 hour periods.
Study:
NCT03964558
Study Brief:
Protocol Section:
NCT03964558