Healthy VolunteerPhase 1NCT01452542
A Phase I Study of the Pharmacokinetic Variability and Relative Bioavailability of the Phase 3 and Common Blend Formulations of Eliglustat in Healthy Adult Subjects
A Phase 1 study testing Eliglustat, common blend proposed commercial formulation and Eliglustat, Phase 3 capsule formulation in people with Healthy Volunteer, run by Genzyme, a Sanofi Company at 1 site in United States.
Trial summary
The primary objective of this pilot study is to determine the within-subject pharmacokinetic (PK) variability and relative bioavailability of single oral 150-mg doses of eliglustat administered as the Phase 3 formulation (3x50-mg capsules) and the common blend proposed commercial formulation (1x150-mg capsule) in… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Eliglustat, common blend proposed commercial formulation and Eliglustat, Phase 3 capsule formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Nov 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject is willing and able to provide signed informed consent.
- The subject is a male or female in good general health and between 18 and 45 years of age, inclusive.
- The subject has a body weight of 50 to 100 kg (110 to 220 lb) with a body mass index (BMI) ≤32 kg/m2 at screening.
- The subject's physical examination, laboratory, vital sign, and ECG test results are within normal limits at screening and Day -3 or, if abnormal, are not considered clinically significant in the opinion of the Investigator.
- The subject has been a non-smoker for at least 6 months prior to the time of providing informed consent, and is willing and able to abstain from smoking (and use of other forms of nicotine) until completion of the safety follow-up visit.
- The subject has not used drugs of abuse for at least 6 months prior to Day -1 and is willing and able to abstain from using drugs of abuse until completion of the safety follow-up visit.
Show all 9Show fewer
- The subject is willing and able to abstain from alcohol for 48 hours prior to the first dose of study drug until completion of the safety follow-up visit.
- The subject is willing and able to abstain from grapefruit or star fruit products for 72 hours prior to the first dose of study drug until completion of the safety follow-up visit.
- The subject, if a female of childbearing potential, has a documented negative pregnancy test at screening and Day 1, and is willing to use a medically accepted form of contraception (as defined in the protocol) from screening until 30 days after the last dose of study drug. A woman of childbearing potential is defined as any female who has not been amenorrheic for at least 2 years or has not undergone a hysterectomy or surgical sterilization.
Who cannot join
- The subject is classified as a CYP2D6 poor metabolizer (or an indeterminate metabolizer with neither allele known to be active) or CYP2D6 ultra-rapid metabolizer (or an indeterminate metabolizer where one allele is known to correspond to ultra-rapid metabolism) based on results of CYP2D6 genotyping performed at screening. (Note: Prior CYP2D6 genotyping results may be used for the purpose of determining study eligibility if a copy of the laboratory report is available and the genotyping results can be interpreted with the same classification system used by the study reference laboratory.)
- The subject has a digestive disorder, including malabsorption, gastroenteritis, pancreatitis, gastroesophageal reflux disease, or inflammatory bowel disease (including Crohn's disease), or any other digestive disorder which, in the opinion of the Investigator, may affect oral bioavailability (e.g., clinically significant constipation, diverticulitis, or irritable bowel syndrome).
- The subject has had a GI surgical procedure that might affect drug transit time, (e.g., cholecystectomy, GI bypass surgery, partial or total gastrectomy, or small bowel resection).
- The subject has any of the following: Clinically significant coronary artery disease including history of myocardial infarction or ongoing signs or symptoms consistent with cardiac ischemia or heart failure; clinically significant arrhythmias or conduction defect such as 2nd or 3rd degree AV block, complete bundle branch block, prolonged QTc interval (e.g., repeated demonstration of a QTc interval ≥450 msec), or sustained ventricular tachycardia.
- The subject has any other clinically significant organic disease, including cardiovascular, renal, hepatic, GI, pulmonary, neurologic, endocrine, metabolic, or psychiatric disease, or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, precludes participation in the trial.
- The subject has received treatment with an inducer of CYP3A4 within 30 days prior to the first dose of study drug.
Show all 20Show fewer
- The subject has received treatment with an inhibitor of CYP3A4 or CYP2D6 within 30 days prior to the first dose of study drug.
- The subject has received an immunization within 30 days prior to the first dose of study drug.
- The subject has received an investigational product within 60 days prior to the first dose of study drug or plans to receive any other investigational product at any time during the course of this study.
- The subject has received any other prescription or non-prescription medication (with the exception of nonprescription-strength ibuprofen and acetaminophen, topical non-steroidal preparations, and topical hydrocortisone (up to 1% strength)) or dietary or herbal supplement within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug, without the approval of both the Investigator and Sponsor.
- The subject has a history of drug allergies that are clinically significant in the opinion of the Investigator (e.g., significant rash or hives).
- The subject has a screening laboratory test result above the upper limit of normal for any of the following liver function tests: aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyltransferase (GGT), and total bilirubin.
- The subject tests positive for human immunodeficiency virus (HIV) antibody, hepatitis C antibody, or hepatitis B surface antigen at screening.
- The subject tests positive for urine drugs of abuse, urine alcohol, or urine cotinine at screening.
- The subject donated blood or blood products within 30 days prior to providing informed consent.
- The subject's schedule or travel plans prevent the completion of all required visits.
- The subject is scheduled for inpatient hospitalization, including elective surgery (inpatient or outpatient), during the study.
- The subject has a history of cancer, with the exception of basal cell carcinoma.
- The subject, if female, is pregnant or lactating.
- The subject, in the opinion of the Investigator, is unable to adhere to the requirements of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot, Phase 1, Single-site, Single-dose, Randomized, Open-label, Two-treatment, Two-sequence, Four-period Replicated Crossover Study Evaluating the Within-subject Pharmacokinetic Variability and Relative Bioavailability of the Phase 3 and Common Blend Formulations of Eliglustat in Healthy Adult Subjects.
The primary objective of this pilot study is to determine the within-subject pharmacokinetic (PK) variability and relative bioavailability of single oral 150-mg doses of eliglustat administered as the Phase 3 formulation (3x50-mg capsules) and the common blend proposed commercial formulation (1x150-mg capsule) in healthy adult subjects, which will be used to plan and support the design of a subsequent bioequivalence study.
Read the detailed description
This will be a single-site, single-dose, randomized, open-label, two-treatment, two-sequence, four-period replicated crossover study in healthy adult subjects. The study will comprise a screening period, four treatment periods with a 7-day washout between dosing in each period, and a safety follow-up visit.
- Conditions
- Healthy Volunteer
- Being tested
- Eliglustat, common blend proposed commercial formulation, Eliglustat, Phase 3 capsule formulation
- Keywords
- Genz-112638
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eliglustat, common blend proposed commercial formulationDrug
Also called Genz-112638
All participants will receive a single oral 150-mg dose of the common blend proposed commercial formulation of eliglustat, administered as one 150-mg strength capsule (Treatment T), on 2 separate dosing occasions.
Eliglustat, Phase 3 capsule formulationDrug
Also called Genz-112638
All participants will receive a single oral 150-mg dose of the Phase 3 capsule formulation of eliglustat, administered as three 50-mg strength capsules (Treatment R), on 2 separate dosing occasions.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Participants will receive a single oral dose of the following two study treatments under fasting conditions, in accordance with a randomly allocated treatment sequence: three 50-mg Phase 3 capsules of eliglustat (Reference Treatment [R]) or one 150-mg common blend capsule of eliglustat (Test Treatment [T]) according to the following treatment sequence: TRTR, with a 7-day washout between dosing in each period. Receives: Drug: Eliglustat, common blend proposed commercial formulation; Drug: Eliglustat, Phase 3 capsule formulation |
| Sequence 2 | Experimental | Participants will receive a single oral dose of the following two study treatments under fasting conditions, in accordance with a randomly allocated treatment sequence: three 50-mg Phase 3 capsules of eliglustat (Reference Treatment [R]) or one 150-mg common blend capsule of eliglustat (Test Treatment [T]) according to the following treatment sequence: RTRT, with a 7-day washout between dosing in each period. Receives: Drug: Eliglustat, common blend proposed commercial formulation; Drug: Eliglustat, Phase 3 capsule formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eliglustat plasma concentration over time
Measured: Plasma concentration-time data will be obtained pre-dose (within 30 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours after dosing in each treatment period.
Secondary outcomes (8)
Area under the plasma concentration time curve (AUC) from time zero to the last time with a quantifiable concentration (AUClast) of eliglustat
Measured: Pre-dose (within 30 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours after dosing in each treatment period.
Area under the concentration time curve (AUC) from time zero extrapolated to infinity (AUC0-∞) of eliglustat
Measured: Pre-dose (within 30 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours after dosing in each treatment period.
Maximum observed eliglustat plasma concentration (Cmax)
Measured: Pre-dose (within 30 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours after dosing in each treatment period.
Time to maximum observed plasma concentration (Tmax)
Measured: Pre-dose (within 30 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours after dosing in each treatment period.
Apparent volume of distribution (Vz/F) of eliglustat
Measured: Pre-dose (within 30 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours after dosing in each treatment period.
Apparent clearance (CL/F) of eliglustat
Measured: Pre-dose (within 30 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours after dosing in each treatment period.
Terminal elimination rate constant (λz) of eliglustat
Measured: Pre-dose (within 30 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours after dosing in each treatment period.
Terminal elimination half-life (t1/2) of eliglustat
Measured: Pre-dose (within 30 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours after dosing in each treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452542
- Sponsor's protocol ID
- GZGD03811
- Status last verified
- Mar 2015
- First submitted
- 12 Oct 2011
- Last updated
- 23 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Phase 1, Single-site, Single-dose, Randomized, Open-label, Two-treatment, Two-sequence, Four-period Replicated Crossover Study Evaluating the Within-subject Pharmacokinetic Variability and Relative Bioavailability of the Phase 3 and Common Blend Formulations of Eliglustat in Healthy Adult Subjects.
- ClinicalTrials.gov ID
- NCT01452542
- Acronym / sponsor ID
- GZGD03811
- Conditions
- Healthy Volunteer
- Keywords
- Genz-112638
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 17 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this pilot study is to determine the within-subject pharmacokinetic (PK) variability and relative bioavailability of single oral 150-mg doses of eliglustat administered as the Phase 3 formulation (3x50-mg capsules) and the common blend proposed commercial formulation (1x150-mg capsule) in healthy adult subjects, which will be used to plan and support the design of a subsequent bioequivalence study.
Detailed description
This will be a single-site, single-dose, randomized, open-label, two-treatment, two-sequence, four-period replicated crossover study in healthy adult subjects. The study will comprise a screening period, four treatment periods with a 7-day washout between dosing in each period, and a safety follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Eliglustat, common blend proposed commercial formulation, Drug: Eliglustat, Phase 3 capsule formulationParticipants will receive a single oral dose of the following two study treatments under fasting conditions, in accordance with a randomly allocated treatment sequence: three 50-mg Phase 3 capsules of eliglustat (Reference Treatment [R]) or one 150-mg common blend capsule of eliglustat (Test Treatment [T]) according to the following treatment sequence: TRTR, with a 7-day washout between dosing in each period. |
| Sequence 2 | Experimental | Drug: Eliglustat, common blend proposed commercial formulation, Drug: Eliglustat, Phase 3 capsule formulationParticipants will receive a single oral dose of the following two study treatments under fasting conditions, in accordance with a randomly allocated treatment sequence: three 50-mg Phase 3 capsules of eliglustat (Reference Treatment [R]) or one 150-mg common blend capsule of eliglustat (Test Treatment [T]) according to the following treatment sequence: RTRT, with a 7-day washout between dosing in each period. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- The subject is willing and able to provide signed informed consent.
- The subject is a male or female in good general health and between 18 and 45 years of age, inclusive.
- The subject has a body weight of 50 to 100 kg (110 to 220 lb) with a body mass index (BMI) ≤32 kg/m2 at screening.
- The subject's physical examination, laboratory, vital sign, and ECG test results are within normal limits at screening and Day -3 or, if abnormal, are not considered clinically significant in the opinion of the Investigator.
- The subject has been a non-smoker for at least 6 months prior to the time of providing informed consent, and is willing and able to abstain from smoking (and use of other forms of nicotine) until completion of the safety follow-up visit.
Key exclusion criteria (20 listed)
- The subject is classified as a CYP2D6 poor metabolizer (or an indeterminate metabolizer with neither allele known to be active) or CYP2D6 ultra-rapid metabolizer (or an indeterminate metabolizer where one allele is known to correspond to ultra-rapid metabolism) based on results of CYP2D6 genotyping performed at screening. (Note: Prior CYP2D6 genotyping results may be used for the purpose of determining study eligibility if a copy of the laboratory report is available and the genotyping results can be interpreted with the same classification system used by the study reference laboratory.)
- The subject has a digestive disorder, including malabsorption, gastroenteritis, pancreatitis, gastroesophageal reflux disease, or inflammatory bowel disease (including Crohn's disease), or any other digestive disorder which, in the opinion of the Investigator, may affect oral bioavailability (e.g., clinically significant constipation, diverticulitis, or irritable bowel syndrome).
- The subject has had a GI surgical procedure that might affect drug transit time, (e.g., cholecystectomy, GI bypass surgery, partial or total gastrectomy, or small bowel resection).
- The subject has any of the following: Clinically significant coronary artery disease including history of myocardial infarction or ongoing signs or symptoms consistent with cardiac ischemia or heart failure; clinically significant arrhythmias or conduction defect such as 2nd or 3rd degree AV block, complete bundle branch block, prolonged QTc interval (e.g., repeated demonstration of a QTc interval ≥450 msec), or sustained ventricular tachycardia.
- The subject has any other clinically significant organic disease, including cardiovascular, renal, hepatic, GI, pulmonary, neurologic, endocrine, metabolic, or psychiatric disease, or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, precludes participation in the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eliglustat, common blend proposed commercial formulationAlso: Genz-112638All participants will receive a single oral 150-mg dose of the common blend proposed commercial formulation of eliglustat, administered as one 150-mg strength capsule (Treatment T), on 2 separate dosing occasions. | Drug | Sequence 1, Sequence 2 |
| Eliglustat, Phase 3 capsule formulationAlso: Genz-112638All participants will receive a single oral 150-mg dose of the Phase 3 capsule formulation of eliglustat, administered as three 50-mg strength capsules (Treatment R), on 2 separate dosing occasions. | Drug | Sequence 1, Sequence 2 |
Primary outcome
Eliglustat plasma concentration over time
Time frame: Plasma concentration-time data will be obtained pre-dose (within 30 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours after dosing in each treatment period.
8 secondary outcomes
Area under the plasma concentration time curve (AUC) from time zero to the last time with a quantifiable concentration (AUClast) of eliglustat
Time frame: Pre-dose (within 30 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours after dosing in each treatment period.
Area under the concentration time curve (AUC) from time zero extrapolated to infinity (AUC0-∞) of eliglustat
Time frame: Pre-dose (within 30 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours after dosing in each treatment period.
Maximum observed eliglustat plasma concentration (Cmax)
Time frame: Pre-dose (within 30 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours after dosing in each treatment period.
Time to maximum observed plasma concentration (Tmax)
Time frame: Pre-dose (within 30 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours after dosing in each treatment period.
Apparent volume of distribution (Vz/F) of eliglustat
Time frame: Pre-dose (within 30 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours after dosing in each treatment period.
Apparent clearance (CL/F) of eliglustat
Time frame: Pre-dose (within 30 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours after dosing in each treatment period.
Terminal elimination rate constant (λz) of eliglustat
Time frame: Pre-dose (within 30 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours after dosing in each treatment period.
Terminal elimination half-life (t1/2) of eliglustat
Time frame: Pre-dose (within 30 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours after dosing in each treatment period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2015.
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Genzyme, a Sanofi Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Eliglustat, common blend proposed commercial formulation and Eliglustat, Phase 3 capsule formulation in people with Healthy Volunteer, run by Genzyme, a Sanofi Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eliglustat plasma concentration over time (time frame: Plasma concentration-time data will be obtained pre-dose (within 30 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours after dosing in each treatment period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2015.