HealthyPhase 1NCT01659944
Study to Evaluate the Effect of Eliglustat on the Pharmacokinetics, Safety and Tolerability of Metoprolol in Healthy Adults
A Phase 1 study testing Eliglustat and Metoprolol in people with Healthy, run by Genzyme, a Sanofi Company at 1 site in United States.
Trial summary
The primary objective is to determine the effect of repeated oral doses of eliglustat 150 mg twice daily (BID) on the pharmacokinetics (PK) of orally administered metoprolol 50 mg in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Eliglustat and Metoprolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jul 2012
- 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 40 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 male or female subject is in good general health and between 18 and 40 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 electrocardiogram (ECG) test results are within normal limits at screening and Day -1 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.
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- 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, grapefruit juice or any other grapefruit-containing products for 72 hours prior to the first dose of study drug until completion of the safety follow-up visit.
- The subject is willing and able to maintain a normal-fiber diet (i.e., to abstain from excess fiber-rich foods) for 72 hours prior to the first dose of study drug until completion of the safety follow-up visit.
- Female subjects of childbearing potential must have a documented negative pregnancy test at screening, Day -1 and prior to dosing on Day 7 and be 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 cytochrome P450 2D6 (CYP2D6) poor metabolizer (or an indeterminate metabolizer with neither allele known to be active) 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, 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 gastrointestinal (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 atrioventricular (AV) block, a PR interval ≥200 msec, complete bundle branch block, prolonged QTc interval (e.g., repeated demonstration of a QTc interval ≥430 msec for male subjects and ≥450 msec for female subjects), sustained ventricular tachycardia, heart rate <55 beats/min, or systolic blood pressure <110 mmHg.
- The subject has a clinically significant organic disease, including cardiovascular, renal, hepatic, gastrointestinal, 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 a disease, clinical finding, or any contraindication that would prohibit the use of metoprolol in a phase 1 study (i.e., risk of disease exacerbation outweighs benefit). Examples of these are clinical findings of glucose intolerance, poor arterial peripheral circulation or bronchospastic disease including asthma.
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- The subject has a history of fainting, postural lightheadedness, or any other postural symptoms.
- The subject has received any 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 or fiber 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 received an immunization within 30 days of providing informed consent.
- The subject has received an investigational product within 30 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 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 female subject of childbearing potential 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 Single-site, Open-label, Fixed-sequence Phase 1 Study Evaluating the Effect of Eliglustat (Genz-112638) on the Pharmacokinetics, Safety and Tolerability of Metoprolol in Healthy Adult Subjects.
The primary objective is to determine the effect of repeated oral doses of eliglustat 150 mg twice daily (BID) on the pharmacokinetics (PK) of orally administered metoprolol 50 mg in healthy adults.
The secondary objective is to assess the safety and tolerability of a single oral dose of metoprolol 50 mg when administered alone and in combination with repeated oral doses of eliglustat 150 mg BID in healthy adults.
- Conditions
- Healthy
- Being tested
- Eliglustat, Metoprolol
- Keywords
- Drug-drug interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EliglustatDrug
Also called Genz-112638
Capsules for oral administration
MetoprololDrug
Also called Lopressor
Tablets for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Metoprolol alone then eliglustat + metoprolol | Experimental | In Period 1 all participants will receive a single oral dose of metoprolol 50 mg on Day 1. In Period 2, participants will receive repeat oral doses of eliglustat 150 mg twice a day from Day 3 to Day 8 and a single oral dose of metoprolol 50 mg on Day 7. Receives: Drug: Eliglustat; Drug: Metoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metoprolol area under the plasma concentration time curve from time zero to the last evaluable concentration (AUC0-last)
Measured: Day 1 and Day 7; predose and up to 48 hours after drug administration
Metoprolol area under the plasma concentration time curve from time zero extrapolated to infinity (AUC0-∞)
Measured: Day 1 and Day 7; Predose and up to 48 hours after drug administration
Secondary outcomes (8)
Maximum plasma concentration (Cmax) for metoprolol
Measured: Day 1 and Day 7; Predose and up to 48 hours after drug administration
Time to maximum plasma concentration (Tmax) for metoprolol
Measured: Day 1 and Day 7; Predose and up to 48 hours after drug administration
Terminal elimination half-life (T1/2) for metoprolol
Measured: Day 1 and Day 7; Predose and up to 48 hours after drug administration
Trough plasma concentration of eliglustat
Eliglustat plasma concentration observed just prior to administration during repeated dosing.
Measured: Day 3, Day 4, Day 5, Day 6, Day 7 and Day 8.
Maximum plasma concentration (Cmax) of eliglustat
Measured: Day 7, up to 12 hours after drug administration
Time to maximum plasma concentration (Tmax) of eliglustat
Measured: Day 7; up to 12 hours after drug administration
Eliglustat area under the plasma concentration time curve during the dosing interval (AUC0-τ)
Measured: Day 7; up to 12 hours after drug administration
Number of participants with adverse events
Measured: Day 1 through to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT01659944
- Sponsor's protocol ID
- GZGD04112
- Status last verified
- Mar 2015
- First submitted
- 6 Aug 2012
- 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 Single-site, Open-label, Fixed-sequence Phase 1 Study Evaluating the Effect of Eliglustat (Genz-112638) on the Pharmacokinetics, Safety and Tolerability of Metoprolol in Healthy Adult Subjects.
- ClinicalTrials.gov ID
- NCT01659944
- Acronym / sponsor ID
- GZGD04112
- Conditions
- Healthy
- Keywords
- Drug-drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Aug 2012 (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 is to determine the effect of repeated oral doses of eliglustat 150 mg twice daily (BID) on the pharmacokinetics (PK) of orally administered metoprolol 50 mg in healthy adults.
The secondary objective is to assess the safety and tolerability of a single oral dose of metoprolol 50 mg when administered alone and in combination with repeated oral doses of eliglustat 150 mg BID in healthy adults.
Study design
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metoprolol alone then eliglustat + metoprolol | Experimental | Drug: Eliglustat, Drug: MetoprololIn Period 1 all participants will receive a single oral dose of metoprolol 50 mg on Day 1. In Period 2, participants will receive repeat oral doses of eliglustat 150 mg twice a day from Day 3 to Day 8 and a single oral dose of metoprolol 50 mg on Day 7. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- The subject is willing and able to provide signed informed consent.
- The male or female subject is in good general health and between 18 and 40 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 electrocardiogram (ECG) test results are within normal limits at screening and Day -1 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 cytochrome P450 2D6 (CYP2D6) poor metabolizer (or an indeterminate metabolizer with neither allele known to be active) 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, 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 gastrointestinal (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 atrioventricular (AV) block, a PR interval ≥200 msec, complete bundle branch block, prolonged QTc interval (e.g., repeated demonstration of a QTc interval ≥430 msec for male subjects and ≥450 msec for female subjects), sustained ventricular tachycardia, heart rate <55 beats/min, or systolic blood pressure <110 mmHg.
- The subject has a clinically significant organic disease, including cardiovascular, renal, hepatic, gastrointestinal, 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 |
|---|---|---|
| EliglustatAlso: Genz-112638Capsules for oral administration | Drug | Metoprolol alone then eliglustat + metoprolol |
| MetoprololAlso: LopressorTablets for oral administration | Drug | Metoprolol alone then eliglustat + metoprolol |
Primary outcome
Metoprolol area under the plasma concentration time curve from time zero to the last evaluable concentration (AUC0-last)
Time frame: Day 1 and Day 7; predose and up to 48 hours after drug administration
Metoprolol area under the plasma concentration time curve from time zero extrapolated to infinity (AUC0-∞)
Time frame: Day 1 and Day 7; Predose and up to 48 hours after drug administration
8 secondary outcomes
Maximum plasma concentration (Cmax) for metoprolol
Time frame: Day 1 and Day 7; Predose and up to 48 hours after drug administration
Time to maximum plasma concentration (Tmax) for metoprolol
Time frame: Day 1 and Day 7; Predose and up to 48 hours after drug administration
Terminal elimination half-life (T1/2) for metoprolol
Time frame: Day 1 and Day 7; Predose and up to 48 hours after drug administration
Trough plasma concentration of eliglustat
Time frame: Day 3, Day 4, Day 5, Day 6, Day 7 and Day 8.
Maximum plasma concentration (Cmax) of eliglustat
Time frame: Day 7, up to 12 hours after drug administration
Time to maximum plasma concentration (Tmax) of eliglustat
Time frame: Day 7; up to 12 hours after drug administration
Eliglustat area under the plasma concentration time curve during the dosing interval (AUC0-τ)
Time frame: Day 7; up to 12 hours after drug administration
Number of participants with adverse events
Time frame: Day 1 through to Day 14
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.
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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 and Metoprolol in people with Healthy, 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 10 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?
Metoprolol area under the plasma concentration time curve from time zero to the last evaluable concentration (AUC0-last) (time frame: Day 1 and Day 7; predose and up to 48 hours after drug administration). The study lists 2 primary outcomes in all. 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.