Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-29 @ 6:01 AM
Study NCT ID:
NCT06872866
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Aspargo Labs, Inc
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: