Current partner codePEPTIDESDE
NCT02082327·Phase 1·INTERVENTIONAL

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 migalastat HCl

DRUG

IV placebo

DRUG

oral migalastat HCl

Timeline

From registration to results.

  1. First posted

    Mar 10, 2014

  2. Study start

    Mar 2014

  3. Primary completion

    Jun 2014

  4. Study completion

    Jun 2014

  5. Results posted

    Not reported

  6. 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.

Primary links

Continue at the source.

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Put the record in context.

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