NCT00789568 - A Phase 1 Study to Evaluate Effects of Sapropterin Dihydrochloride on QTc Intervals in Healthy Adult Subjects | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 31, 2008

Primary Completion Date

January 31, 2009

Study Completion Date

October 31, 2009

Conditions

Phenylketonuria

Interventions

DRUG

sapropterin dihydrochloride

20 mg/kg and 100 mg/kg

DRUG

Moxifloxacin

Moxifloxacin is included as a positive control to demonstrate the assay sensitivity based on the expected increased QTc response.

DRUG

Moxifloxacin placebo

Moxifloxacin placebo tablet

Trial Locations (1)

PRACS Institute, Ltd., Fargo