Trial intelligence / Profile preview

PK of Sapropterin Dihydrochloride Oral Suspension vs Kuvan in Healthy Subjects

NCT06481709Phase 1Completed

Sponsor
APR Applied Pharma Research
Start
Jul 2024
Primary completion
Aug 2024
Modality
Allosteric Modulators, Metabolically Activated Prodrugs
Countries
1
01

Overview

Phase 1, randomised, open-label trial of sapropterin in phenylketonuria (PKU) (4 arms), sponsored by APR Applied Pharma Research. Primary endpoints: Uncorrected Sapropterin AUC0-t, Baseline-corrected Sapropterin AUC0-t and 4 more. Started Jul 2024; status: completed.

02

Drugs

sapropterin
03

Conditions

phenylketonuria (PKU)

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