Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359281
Status:
COMPLETED
Last Update Posted:
2018-02-23
First Post:
2006-07-31
Brief Title:
Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Agents
Sponsor:
Aegerion Pharmaceuticals Inc
Organization:
Aegerion Pharmaceuticals Inc
Study Overview
Official Title:
A Phase II Fixed-sequenced Open- Label Research Study to Assess Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Therapies in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II open-label research study was conducted in 129 healthy volunteers Each subject will be given one initial oral dose of one of 7 FDA-approved medications probe drugs followed by a 7 day period where subjects receive the study medication AEGR-733 at 10 or 60 mg On study day 8 subjects will receive the second oral dose of the same probe drug that was given on day 1 and a last dose of AEGR-733 total of 7 dosesSubjects will return in 1 week for a final safety visit Each FDA- approved probe drug will be given to ten 10 or fifteen 15 subjects
Safety pharmacokinetic and pharmacodynamic assessments will be performed
Safety pharmacokinetic and pharmacodynamic assessments will be performed
Detailed Description:
Objectives
Primary To evaluate the effects of low and high doses of AEGR-733 on the pharmacokinetics of 6 FDA-approved medications that are likely to be used in combination with AEGR-733 as assessed by
Pharmacokinetic parameters Cmax Tmax T12 and AUC area under the curve
Secondary To evaluate the safety of AEGR-733 in combination with other lipid lowering agents in healthy subject as assessed by
Changes in associated liver enzymes AST ALT and Alkaline Phosphatase Total Bilirubin
Changes in all reported adverse events
To evaluate the effects of AEGR-733 in combination with other lipid lowering agents on the following lipids and lipoproteins TC LDL-C VLDL TG HDL-C ApoB and ApoAI
40 STUDY DESIGN AND RATIONALE
41 STUDY DESIGN This is a single-center phase II clinical trial consisting of a eight 8 day open-label phase to assess the pharmacokinetic drug interactions of AEGR-733 on 6 probe drugs in healthy volunteers followed by a one week safety visit 105 subjects will be enrolled into this fixed-sequenced research study Eligible subjects based on the screening visit will come to the GCRC for an inpatient visit 25-36 hr depending on if they come in evening before study day 1 or morning of On the morning of study day 1 subjects will be assigned to one of 6 probe drugsA-H below and will take one dose of this medication Timed blood samples will be drawn just before the administration of the probe drug and during the following times after drug administration 1234568101218 and 24 hrs Prior to discharge after the 24 h blood sample subjects will take an oral dose of AEGR-733 at 10 mg or 60 mg Subjects will be given a 5 day supply of AEGR-733 at 10 mg or 60 mg to be taken once daily in the morning for the next 5 days through day 7 On study day 8 subjects will take a final dose of AEGR-733 at 10 mg or 60 mg total doses 7 simultaneously with the same probe drug they took on day 1 Timed blood samples will be drawn just before the administration of the probe drug and AEGR-733 as well as 1234568101218 and 24 hours after study drug administration After the 24 hour blood sample subjects will be discharged 15 subjects who participate in this study will receive dextromethorphan as the probe drug which requires urine collection for 8 hours post dose Blood for pharmacokinetic samples will not be collected on these subjects Subjects receiving dextromethorphan may leave after the 8 hour urine collection at visits 2 and 3 referred to as the inpatient visits All subjects will come back 1 week later for a final visit to check safety lab parameters including liver transaminases and total bilirubin Subjects will be instructed to abstain from drinking any alcoholic beverages once screened until study completion Subjects who are not willing to comply with these requests will not be enrolled
The FDA-approved lipid-lowering therapies will include
A Atorvastatin 20 mg n15and AEGR-733 10 mg B Ezetimibe 10 mg n10and AEGR-733 10 mg C Simvastatin 20 mg n15and AEGR-733 10 mg D Rosuvastatin 20 mg n10and AEGR-733 10 mg E Micronized fenofibrate 145 mg n10and AEGR-733 10 mg F Atorvastatin 20 mg n15 and AEGR-733 60 mg G Rosuvastatin 20 mg n15 and AEGR-733 60 mg H Dextromethorphan 30 mg n15 and AEGR-733 60 mg I Extended Release Niacin 1000 mg n20 and AEGR-733 10 mg
Primary To evaluate the effects of low and high doses of AEGR-733 on the pharmacokinetics of 6 FDA-approved medications that are likely to be used in combination with AEGR-733 as assessed by
Pharmacokinetic parameters Cmax Tmax T12 and AUC area under the curve
Secondary To evaluate the safety of AEGR-733 in combination with other lipid lowering agents in healthy subject as assessed by
Changes in associated liver enzymes AST ALT and Alkaline Phosphatase Total Bilirubin
Changes in all reported adverse events
To evaluate the effects of AEGR-733 in combination with other lipid lowering agents on the following lipids and lipoproteins TC LDL-C VLDL TG HDL-C ApoB and ApoAI
40 STUDY DESIGN AND RATIONALE
41 STUDY DESIGN This is a single-center phase II clinical trial consisting of a eight 8 day open-label phase to assess the pharmacokinetic drug interactions of AEGR-733 on 6 probe drugs in healthy volunteers followed by a one week safety visit 105 subjects will be enrolled into this fixed-sequenced research study Eligible subjects based on the screening visit will come to the GCRC for an inpatient visit 25-36 hr depending on if they come in evening before study day 1 or morning of On the morning of study day 1 subjects will be assigned to one of 6 probe drugsA-H below and will take one dose of this medication Timed blood samples will be drawn just before the administration of the probe drug and during the following times after drug administration 1234568101218 and 24 hrs Prior to discharge after the 24 h blood sample subjects will take an oral dose of AEGR-733 at 10 mg or 60 mg Subjects will be given a 5 day supply of AEGR-733 at 10 mg or 60 mg to be taken once daily in the morning for the next 5 days through day 7 On study day 8 subjects will take a final dose of AEGR-733 at 10 mg or 60 mg total doses 7 simultaneously with the same probe drug they took on day 1 Timed blood samples will be drawn just before the administration of the probe drug and AEGR-733 as well as 1234568101218 and 24 hours after study drug administration After the 24 hour blood sample subjects will be discharged 15 subjects who participate in this study will receive dextromethorphan as the probe drug which requires urine collection for 8 hours post dose Blood for pharmacokinetic samples will not be collected on these subjects Subjects receiving dextromethorphan may leave after the 8 hour urine collection at visits 2 and 3 referred to as the inpatient visits All subjects will come back 1 week later for a final visit to check safety lab parameters including liver transaminases and total bilirubin Subjects will be instructed to abstain from drinking any alcoholic beverages once screened until study completion Subjects who are not willing to comply with these requests will not be enrolled
The FDA-approved lipid-lowering therapies will include
A Atorvastatin 20 mg n15and AEGR-733 10 mg B Ezetimibe 10 mg n10and AEGR-733 10 mg C Simvastatin 20 mg n15and AEGR-733 10 mg D Rosuvastatin 20 mg n10and AEGR-733 10 mg E Micronized fenofibrate 145 mg n10and AEGR-733 10 mg F Atorvastatin 20 mg n15 and AEGR-733 60 mg G Rosuvastatin 20 mg n15 and AEGR-733 60 mg H Dextromethorphan 30 mg n15 and AEGR-733 60 mg I Extended Release Niacin 1000 mg n20 and AEGR-733 10 mg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Aegerion 002 PK study | None | None | None |