NCT06481709

Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects

A Pilot, Phase 1, Randomized, Open-Label, Single-Dose, Four-Way Crossover Study to Compare the Pharmacokinetics of Sapropterin Dihydrochloride 100 mg/mL Oral Suspension (Product Code: RLF-OD032) (Test) With Kuvan® (Sapropterin Dihydrochloride) 100 mg Powder for Oral Solution (Reference) and to Evaluate the Effect of Food and the Effect of Water on the Bioavailability of Sapropterin Dihydrochloride 100 mg/mL Oral Suspension in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: APR Applied Pharma Research s.a. · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a single center, Phase 1, randomized, open-label, single-dose, 4 treatment, 4-period, 4-sequence, crossover study designed to compare the pharmacokinetics (PK) of sapropterin from the Test and Reference products, and to evaluate the effect of food and the effect of water administration on the bioavailability of sapropterin from the Test product in healthy subjects. .

Detailed description

In each period, subjects will receive a single 10 mg/kg dose of sapropterin dihydrochloride on Day 1, under fasting or fed conditions, and with or without water, followed by 24 hours of PK sampling. The study will include a screening visit from Day -30 to Day -1. In each period, eligible subjects will be admitted to the clinical site on Day -1 and will be confined until completion of the assessments on Day 2. There will be a washout period of at least 7 days between doses.

Conditions

• Bioavailability

Interventions

Type	Name	Description
DRUG	RLF-OD032	100 mg/mL oral suspension
DRUG	Kuvan	100 mg powder for oral solution

Timeline

• Start date: 2024-07-30
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2024-07-01
• Last updated: 2025-06-12
• Results posted: 2025-06-12

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study