Drug-drug Interaction Study

• Status: Completed
• Trial end date: 2013-01-04
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates drug-drug interactions between AT2220 (duvoglustat) and recombinant human alpha-glucosidase (rhGAA, also known as alglucosidase alfa) in participants with Pompe Disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amicus Therapeutics
• Treatments: 1-Deoxynojirimycin

Criteria

Inclusion Criteria:

• Male or female, diagnosed with Pompe disease and between 18 and 65 years of age, inclusive

• Participant has been on a stable regimen and dose of rhGAA for at least 3 months before screening (stable regimen defined as currently receiving rhGAA every 2 weeks and stable dose defined as not varying by more than ± 10%)

• Participant has an estimated glomerular filtration rate (eGFR) ≥ 50 mL/min at Screening; eGFR to be estimated using the 4-parameter Modification of Diet in Renal Disease (MDRD) equation:

eGFR (mL/min/1.73 m^2) = 175 x (Scr)^(-1.154) x (Age)^(-0.203) x (0.742 if female) x (1.212 if African-American)

• Male and female participants of childbearing potential agree to use medically accepted methods of contraception during the study and for 30 days after study completion

• Participant is willing and able to provide written informed consent and is able to comply with all study procedures

Exclusion Criteria:

• Participant has had a documented transient ischemic attack, ischemic stroke, unstable angina, or myocardial infarction within the 3 months before Screening

• Participant has clinically significant unstable cardiac disease (for example, cardiac disease requiring active management, such as symptomatic arrhythmia, unstable angina, or New York Heart Association class III or IV congestive heart failure)

• Participant requiring mechanical ventilation or is confined to a wheelchair

• Participant has a history of allergy or sensitivity to study drug (including excipients) or other iminosugars (for example, miglustat, miglitol)

• Participant is pregnant or breastfeeding

• Participant tests positive for hepatitis B surface antigen or hepatitis C antibody

• Participant has received any investigational/experimental drug or device within 30 days of Screening

• Participant has any intercurrent illness or condition that may preclude the participant from fulfilling the protocol requirements or suggests to the investigator that the potential participant may have an unacceptable risk by participating in this study