DRUG
A Phase 1 Study To Evaluate the Safety of Migalastat Hydrochloride Given Intravenously to Healthy Volunteers
Status
Completed
Phase
Phase 1
Enrollment
31
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of IV migalastat HCl alone and to determine absolute bioavailability for oral migalastat HCl as compared to IV administered migalastat HCl in healthy volunteers. The data from this study will help us understand how migalastat works in the body and will help us determine what would be an effective dose in future studies with migalastat hydrochloride.
Interventions
Treatment arms and agents.
DRUG
IV placebo
DRUG
oral migalastat HCl
Timeline
From registration to results.
First posted
Mar 10, 2014
Study start
Mar 2014
Primary completion
Jun 2014
Study completion
Jun 2014
Results posted
Not reported
Registry updated
Jun 18, 2014
Outcomes
What the study measures.
Primary outcomes
Plasma pharmacokinetics of migalastat
Time frame · Pre-dose, 0.25, 0.5, 1, 1.5, 2.0, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48
To investigate the effect on the body of migalastat following a single 2 hour IV infusion in healthy subjects.
Safety and tolerability of migalastat
Time frame · 48 hours
Adverse events, clinical laboratory test values, vital signs, ECG, physical examinations
Secondary outcomes
Plasma pharmacokinetics of migalastat
Time frame · Pre-dose, 0.25, 0.5, 1, 1.5, 2.0, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48
To assess the dose proportionality of migalastat following a single 2 hour IV infusion
Urinary pharmacokinetics
Time frame · Pre dose, between 0-6, 6-12 and 12-24 hours after start of infusion
To estimate the urinary excretion of unchanged migalastat following a single 2 hour IV infusion in healthy subjects
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Sex
- ALL
- Healthy volunteers
- Yes
Inclusion Criteria: * Males and females between 18 and 45 years of age. * Body weight range ≥ 50 kg ≤ 100 kg and BMI within the range 18.5 - 29.9 kg/m2. * Healthy as determined by a responsible and experienced physician, based on a medial evaluation. * Male and female subjects of childbearing potential agree to adhere to the contraception requirements. * Capable of giving written informed consent. Exclusion Criteria: * History of sensitivity to migalastat HCl or related iminosugars (eg, miglitol, miglustat), or other significant drug allergy. * Past medical history, or physical examination findings, of clinically significant abnormalities that may put the subject at risk or interfere with outcome variables. * Positive pre-study drug/alcohol screen. * Pregnant or lactating females. * The subject has participated in a clinical trial and has received an investigational product within 60 days prior to the first dosing day in the current study.
Study locations
1 registered sites.
Netherlands. Showing up to 24 locations stored in the fast local snapshot.
PRA International
Groningen, Netherlands
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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