NCT06872866

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

A Phase 1 Food-Effect Study of 100 mg of 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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Aspargo Labs, Inc · Industry
• Sex: Male
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	ASP-001.1	Oral liquid suspension of sildenafil
DEVICE	ASP-001.1	Bottle/pump containing ASP-001.1 suspension

Timeline

• Start date: 2025-04-15
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2025-03-12
• Last updated: 2025-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study