Last updated: 11/03/2018 18:53:08
A Randomized, Open-Label, 5-Period Crossover Study to Evaluate the Effect of Meal Type and Timing on the Pharmacokinetics of Migalastat Hydrochloride in Healthy Volunteers.
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Randomized, Open-Label, 5-Period Crossover Study to Evaluate the Effect of Meal Type and Timing on the Pharmacokinetics of Migalastat Hydrochloride in Healthy Volunteers.
Trial description: A 5-period crossover study to evaluate the effect of meal type and timing on migalastat HCl pharmacokinetics in healthy male and female subjects. Subjects will be randomly assigned to 1 of 5 treatment sequences and will receive each treatment over the course of 5 weekly periods.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Maximum observed plasma concentration of migalastat HCl after a single dose
Timeframe: 5 weeks (60 PK timepoints)
Time of occurence of maximum observed plasma concentration of migalastat HCl after a single dose
Timeframe: 5 weeks (60 PK timepoints)
Area under the plasma concentration-time curve of migalastat HCl after a single dose from time 0 (before dosing) to infinity
Timeframe: 5 weeks (60 PK timepoints)
Terminal phase half life of migalastat HCl after a single dose
Timeframe: 5 weeks (60 PK timepoints)
Apparent clearance following oral dosing of migalastat HCl after a single dose
Timeframe: 5 weeks (60 PK timepoints)
Area under the plasma concentration-time curve of migalastat HCl after a single dose from time 0 (before dosing) to the time of the last quantifiable concentration
Timeframe: 5 weeks (60 PK timepoints)
Secondary outcomes:
Adverse Events
Timeframe: 5 weeks
Clinical Laboratory Tests
Timeframe: 5 weeks
Vital Signs
Timeframe: 5 weeks
ECGs
Timeframe: 5 weeks
Physical Examination
Timeframe: 5 weeks
Interventions:
Enrollment:
20
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Fabry disease
Product
migalastat
Collaborators
Not applicable
Study date(s)
October 2011 to December 2011
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 Years
Accepts healthy volunteers
yes
- Male or Female aged 18 to 65 years inclusive
- Healthy, as determined by study physician
- Positive for HIV or Hepatitis B and/or C viruses
- History of drug or alcohol abuse or addiction within 2 years
Inclusion and exclusion criteria
Inclusion criteria:
- Male or Female aged 18 to 65 years inclusive
- Healthy, as determined by study physician
- Capable of giving informed consent
Exclusion criteria:
- Positive for HIV or Hepatitis B and/or C viruses
- History of drug or alcohol abuse or addiction within 2 years
- Smoker or consumes tobacco products
- Participation in a clinical trial within 30 days of scheduled first dose
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2011-23-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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