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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004872-21 | EudraCT Number | EudraCT |
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The primary objective of this trial is to investigate effect of faldaprevir on steady state pharmacokinetics of raltegravir.
The assessment of safety and tolerability will be an additional objective of this trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raltegravir | Active Comparator | coated tablets, oral administration with 240 ml water |
|
| Raltegravir + Faldaprevir | Experimental | coated tablets and soft gelatine capsule, oral administration with 240 ml water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltegravir | Drug | low dose oral administration |
| |
| Raltegravir |
| Measure | Description | Time Frame |
|---|---|---|
| AUC( Tau,ss) | AUC tau,ss (area under the concentration-time curve of the Raltegravir in plasma at steady state over the uniform dosing interval tau) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of AUC tau,ss and their 2-sided 90% confidence intervals (CI) were calculated. The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for 'subject' and 'treatment'. RAL: Raltegravir , FDV: Faldaprevir | 0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132 hours after RAL and FDV administration |
| Cmax ,ss | C max,ss (maximum measured concentration of the Raltegravir in plasma at steady state) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of Cmax,ss and their 2-sided 90% confidence intervals (CI) were calculated. The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for 'subject' and 'treatment'. RAL: Raltegravir , FDV: Faldaprevir | 0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132hours after RAL and FDV administration |
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Inclusion criteria:
1. healthy male subjects
Exclusion criteria:
1. Any relevant deviation from healthy conditions
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1220.65.1 Boehringer Ingelheim Investigational Site | Mannheim | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | Total number of patients randomised and treated in the study.This was a open label trial with two periods in a fixed sequence. All subjects were to receive the following 2 treatments, A]Raltegravir B]Raltegravir+Faldaprevir. The two treatments were separated by washout period of at least 7 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1: Raltegravir |
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| ||||||||||||||||||
| Washout Period of at Least 7 Days |
| |||||||||||||||||||
| Treatment Period 2: Raltegravir + Faldap |
|
The total number of participants N analysed for baseline characteristics is not same as the number of participants enrolled as one subject was not treated after being enrolled
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Total number of patients randomised and treated in the study.This was a open label trial with two periods in a fixed sequence. All subjects were to receive the following 2 treatments, A]Raltegravir B]Raltegravir+Faldaprevir The two treatments were separated by washout period of at least 7 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUC( Tau,ss) | AUC tau,ss (area under the concentration-time curve of the Raltegravir in plasma at steady state over the uniform dosing interval tau) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of AUC tau,ss and their 2-sided 90% confidence intervals (CI) were calculated. The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for 'subject' and 'treatment'. RAL: Raltegravir , FDV: Faldaprevir | Pharmacokinetic(PK) set:Subjects who received atleast 1 dose of study medication and who provided at least 1 observation for at least 1 PK endpoint without any important protocol violations relevant to the evaluation of relative bioavailability and did not experience emesis at or before 2 times median tmax on the pk study days of both trial periods | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132 hours after RAL and FDV administration |
Up to 23 days (+1day)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Raltegravir | coated tablets, oral administration with 240 ml water Raltegravir: low dose oral administration |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MEDDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| C552340 | faldaprevir |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
low dose oral administration |
|
| Faldaprevir | Drug | medium dose oral administration |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Raltegravir | Raltegravir coated tablets Oral with 240 mL of water Days 1 to 3: 400 mg raltegravir twice daily Day 4: 400 mg raltegravir once daily |
| OG001 | Raltegravir + Faldaprevir | Raltegravir coated tablets and Faldaprevir soft gelatin capsules Oral with 240 mL of water Day 1: 400 mg raltegravir twice daily and 240 mg faldaprevir twice daily (loading dose) Days 2 to 5: 400 mg raltegravir twice daily and 240 mg faldaprevir once daily Day 6: 400 mg raltegravir once daily and 240 mg faldaprevir once daily |
|
|
|
| Primary | Cmax ,ss | C max,ss (maximum measured concentration of the Raltegravir in plasma at steady state) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of Cmax,ss and their 2-sided 90% confidence intervals (CI) were calculated. The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for 'subject' and 'treatment'. RAL: Raltegravir , FDV: Faldaprevir | Pharmacokinetic(PK) set:Subjects who received atleast 1 dose of study medication and who provided at least 1 observation for at least 1 PK endpoint without any important protocol violations relevant to the evaluation of relative bioavailability and did not experience emesis at or before 2 times median tmax on the pk study days of both trial periods | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132hours after RAL and FDV administration |
|
|
|
|
| 0 |
| 24 |
| 6 |
| 24 |
| EG001 | Raltegravir + Faldaprevir | coated tablets and soft gelatine capsule, oral administration with 240 ml water Raltegravir: low dose oral administration Faldaprevir: medium dose oral administration | 0 | 23 | 13 | 23 |
| Dizziness | Nervous system disorders | MEDDRA 15.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
|
| Fatigue | General disorders | MEDDRA 15.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.