Last updated: 11/03/2018 19:08:54
An Open-Label Study to Determine the Safety and Pharmacokinetics of AT1001 in Subjects with Impaired Renal Function and Healthy Subjects with Normal Renal Function (AT1001-015)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An Open-Label Study to Determine the Safety and Pharmacokinetics of AT1001 in Subjects with Impaired Renal Function and Healthy Subjects with Normal Renal Function (AT1001-015)
Trial description: This study will assess the safety, tolerability, and pharmacokinetics (PK) study of a single dose of 150 mg AT1001 (migalastat HCl, GR181413A) administered orally to healthy subjects with normal renal function and to subjects with mild, moderate, and severe renal impairment.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
N\A
Primary outcomes:
Number of subjects with adverse events to assess safety and tolerability
Timeframe: Day 1 to Day 10 (+1)
Clinical laboratory test values to assess safety and tolerability
Timeframe: Day -28 to Day 10 (+1)
Vital signs to assess safety and tolerability
Timeframe: Day -28 to Day 10 (+1)
Physician examination to assess safety and tolerability
Timeframe: Day -28 to Day 10 (+1)
Measure of ECG to assess safety and tolerability
Timeframe: Day -28 to Day 10 (+1)
Secondary outcomes:
Maximum observed concentration (Cmax) of AT1001
Timeframe: Day 1 to Day 6
Time to achieve maximum concentration (Tmax) of AT1001
Timeframe: Day 1 to Day 6
Apparent terminal elimination half life (t1/2 ) of AT1001
Timeframe: Day 1 to Day 6
Area under the concentration-time curve from time zero to the last measurable concentration (AUC 0-t ) of AT1001
Timeframe: Day 1 to Day 6
Area under the concentration-time curve extrapolated to infinity (AUC 0-inf) of AT1001
Timeframe: Day 1 to Day 6
Apparent terminal elimination rate constant for AT1001
Timeframe: Day 1 to Day 6
Oral clearance of AT1001
Timeframe: Day 1 to Day 6
Oral volume of distribution of AT1001
Timeframe: Day 1 to Day 6
Interventions:
Enrollment:
32
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
Amicus Therapeutics
Study date(s)
August 2011 to April 2012
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 75 Year
Accepts healthy volunteers
yes
- Inclusion Criteria
- All subjects
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria All subjects -males or females aged 18 to 70 years inclusive (subjects with normal renal function, mild or moderate renal impairment), and 18 to 75 years inclusive (subjects with severe renal impairment) -body mass index 18.0 to 40.0 kilogram (kg)/square meter (m^2) inclusive -females who are non-pregnant, non-lactating, or postmenopausal for >=1 year, surgically sterile for >= 90 days, or agree to use approved methods of contraception -males will be sterile or use approved methods of contraception -understands and signs informed consent form Healthy subjects with normal renal function -negative test for selected drugs of abuse (excludes alcohol) at Screening and Check-in -good health with no clinically significant medical history, physical examination, vital signs, or 12-lead ECG -clinical laboratory tests within the reference range or not clinically significant -normal renal function (estimated CLcr >90 mL/min) at Screening Subjects with mild, moderate or severe renal impairment -negative test for selected drugs of abuse (excludes alcohol) at Screening and Check-in or verification of a prescription for a positive test -renal impairment (estimated CLcr <90 mL/min) -evidence of stable renal impairment defined as two separate estimated CLcr values within 25% -clinical laboratory results consistent with their renal condition or of no clinical significance for the study -abnormal laboratory values must not be clinically significant. Anemia secondary to renal disease is acceptable if hemoglobin is ≥9 g/dL and no clinically significant symptoms. Liver enzymes and bilirubin must be below twice the upper normal level -subjects with renal impairment must have stable underlying medical conditions < 90 days before study start -stable medication regimen(s) (no new drug(s) or changed dosage(s) <30 days before study drug) -in good general health, allowing for concurrent illnesses associated with chronic kidney disease Exclusion Criteria: All subjects: -history of hypersensitivity or allergies to any drug, unless approved by the Investigator and reviewed by Sponsor/Medical Monitor -participation in a study with receipt of an investigational drug < 5 half-lives or 30 days (whichever is longer) before Check-in -use of alcohol, grapefruit, or caffeine-containing foods or beverages < 72 hours before Check-in, unless approved by the Investigator and reviewed by the Sponsor/Medical Monitor -poor peripheral venous access -whole blood donation < 56 days before dosing or plasma donation < 14 days before dosing -receipt of blood products < 2 months before Check-in -history or presence of any clinically significant abnormal ECG -history of alcoholism or drug addiction < 1 year before Check-in -positive test for HIV antibody, HBsAg or anti-HCV -pregnant or breastfeeding Healthy subjects with normal renal function: -use of any tobacco- or nicotine-containing products < 6 months before Check-in -clinically significant (history of or active) cardiac, hepatic, pulmonary, endocrine, neurological, infectious, gastrointestinal, hematologic, oncologic, or psychiatric disease putting the subject at increased risk or could interfere with study objectives -screening laboratory values outside normal range and deemed clinically significant by the Investigator -use of a prescription drug < 14 days of dosing or a non-prescription drug < 7 days before dosing or need of concomitant medication during the study Subjects with mild, moderate, or severe renal impairment: -unstable disease (concurrent medical conditions that have changed significantly < 90 days) -changes in concomitant prescription medications < 30 days before dosing or expected changes during study -use of new non-prescription medication < 30 days before dosing
- renal transplant -acute or chronic non-renal condition limiting the subject’s ability to complete and/or participate in the study
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
2012-23-04
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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