Drug-Drug Interaction Study Between AT1001 (Migalastat Hydrochloride) and Agalsidase in Participants With Fabry Disease
NCT ID: NCT01196871
Last Updated: 2018-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2011-02-02
2012-10-09
Brief Summary
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Detailed Description
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Migalastat was administered orally. Agalsidase alfa was administered as a 40-minute intravenous (IV) infusion and agalsidase beta was administered as a 2-hour (hr) IV infusion.
Stage 1 consisted of 3 treatment periods with 14 days intervening between each period.
Period 1, Day 1: agalsidase was administered alone.
Period 2, Day 1: migalastat was administered, followed 2 hrs later by agalsidase.
Period 3, Day 7: migalastat was administered alone.
Stage 2 consisted of two 14-day treatment periods in which the plasma exposure of migalastat was characterized when migalastat was administered with agalsidase solely to confirm the attainment of adequate migalastat plasma concentrations.
Period 1, Day 1: agalsidase was administered as an IV infusion using a calibrated infusion pump.
Period 2, Day 1: migalastat was administered, followed 2 hrs later by agalsidase.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Agalsidase Beta (0.5 mg/kg)-Migalastat (150 mg)
Migalastat HCl
Oral capsules, single dose
Agalsidase Beta
IV infusion, single dose
Agalsidase Beta (1.0 mg/kg)-Migalastat (150 mg)
Migalastat HCl
Oral capsules, single dose
Agalsidase Beta
IV infusion, single dose
Agalsidase Alfa (0.2 mg/kg)-Migalastat (150 mg)
Migalastat HCl
Oral capsules, single dose
Agalsidase Alfa
IV infusion, single dose
Agalsidase Beta (0.5 mg/kg)-Migalastat (450 mg)
Migalastat HCl
Oral capsules, single dose
Agalsidase Beta
IV infusion, single dose
Agalsidase Beta (1.0 mg/kg)-Migalastat (450 mg)
Migalastat HCl
Oral capsules, single dose
Agalsidase Beta
IV infusion, single dose
Agalsidase Alfa (0.2 mg/kg)-Migalastat (450 mg)
Migalastat HCl
Oral capsules, single dose
Agalsidase Alfa
IV infusion, single dose
Interventions
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Migalastat HCl
Oral capsules, single dose
Agalsidase Beta
IV infusion, single dose
Agalsidase Alfa
IV infusion, single dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index between 18-35 kg per meter squared
* Had initiated treatment with agalsidase at least 1 month prior to screening, and had received at least 2 infusions before screening
* Had stable dose level, dosing regimen, and form of agalsidase for at least 1 month before screening
* Had an estimated creatinine clearance greater than or equal to 50 milliliters (mL)/minute at screening
* Agreed to use medically accepted methods of contraception during the study and for 30 days after study completion
* Were willing and able to provide written informed consent
Exclusion Criteria
* Had 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)
* History of allergy or sensitivity to study drug (including excipients) or other iminosugars (such as miglustat, miglitol)
* Required a concomitant medication prohibited by the protocol: Glyset® (miglitol), or Zavesca® (miglustat)
* Any investigational/experimental drug or device within 30 days of screening, except for use of investigational enzyme replacement therapy for Fabry disease
* Had any intercurrent illness or condition that might have precluded the participant from fulfilling the protocol requirements or suggested to the investigator that the potential participant might have had an unacceptable risk by participating in this study
18 Years
65 Years
MALE
No
Sponsors
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Amicus Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor Clinical Research
Role: STUDY_DIRECTOR
Amicus Therapeutics
Locations
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Birmingham, Alabama, United States
Decatur, Georgia, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Springfield, Virginia, United States
Nedlands, , Australia
Parkville, , Australia
Edegem, , Belgium
Montreal, , Canada
Amsterdam, , Netherlands
Countries
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References
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Warnock DG, Bichet DG, Holida M, Goker-Alpan O, Nicholls K, Thomas M, Eyskens F, Shankar S, Adera M, Sitaraman S, Khanna R, Flanagan JJ, Wustman BA, Barth J, Barlow C, Valenzano KJ, Lockhart DJ, Boudes P, Johnson FK. Oral Migalastat HCl Leads to Greater Systemic Exposure and Tissue Levels of Active alpha-Galactosidase A in Fabry Patients when Co-Administered with Infused Agalsidase. PLoS One. 2015 Aug 7;10(8):e0134341. doi: 10.1371/journal.pone.0134341. eCollection 2015.
Other Identifiers
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AT1001-013
Identifier Type: -
Identifier Source: org_study_id