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:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT06872866
Brief Summary:
The objective of this phase 1 study is to evaluate the food effect of 100 mg Hezkue Turbo® (ASP-001.1, sildenafil) under fed versus 100 mg of Hezkue Turbo® (ASP-001.1, sildenafil) under fasted conditions in healthy adult male subjects
Detailed Description:
This is a Phase 1, open-label, single-center, two-period, two-treatment crossover study designed to evaluate the pharmacokinetics (PK), food effect, safety, and tolerability of ASP-001.1 (oral liquid suspension of sildenafil) under fed versus fasted conditions in healthy adult male participants. The crossover design ensures that each participant receives ASP-001.1 under both fed and fasted conditions, allowing for direct within-subject comparison of the pharmacokinetic parameters. The study aims to determine the effect of food on the absorption and bioavailability of ASP-001.1 and to assess its safety and tolerability, including the potential for oral irritation, dizziness, or headache.
Subjects will be randomly assigned to one of two sequences for the crossover study:
* Sequence 1: ASP-001.1 under fasted conditions in Treatment Period 1, followed by ASP-001.1 under fed conditions in Treatment Period 2.
* Sequence 2: ASP-001.1 under fed conditions in Treatment Period 1, followed by ASP-001.1 under fasted conditions in Treatment Period 2.
Randomization will occur after screening and prior to Treatment Period 1 dosing.
Study:
NCT06872866
Study Brief:
Protocol Section:
NCT06872866