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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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Healthy volunteers are being recruited for this pharmacokinetics study. The objective is to characterize the pharmacokinetic properties of maraviroc alone and when administered with rifabutin and to assess rifabutin and 25-O-desacetyl-rifabutin pharmacokinetics compared to the literature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maraviroc | Experimental | Two period pharmacokinetic drug-drug interaction Period one -Maraviroc alone; Period two -Maraviroc and Rifabutin Substance: Maraviroc (Celsentri, MVC) tablets, 300 mg; dose: oral, 300 mg (1 tablet) twice daily Substance: Rifabutin (mycobutin, RFB) capsules, 150 mg; dose: oral, 300 mg (2 capsules) once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifabutin | Drug | Substance: Rifabutin Daily dose: oral, 300 mg once daily (8:00 am) for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of Maraviroc and Rifabutin AUC 0-12/24 | Maraviroc pharmacokinetics: Maraviroc only AUC (h*μg/L), Maraviroc + Rifabutin AUC (h*μg/L), Rifabutin AUC (h*μg/L), 25-O-desacetyl rifabutin AUC (h*μg/L). | Maraviroc: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hour. Rifabutin: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hour.. |
| Maraviroc and Rifabutin C12/C24/Cmax PK Concentrations in Plasma. | Maraviroc + Rifabutin pharmacokinetics: Maraviroc only Cmax (μg/L), Maraviroc only C12 (μg/L), Maraviroc + Rifabutin Cmax (μg/L), Maraviroc + Rifabutin C12 (μg/L), Rifabutin Cmax (μg/L), Rifabutin C24 (μg/L), 25-O-desacetyl rifabutin Cmax (μg/L), 25-O-desacetyl rifabutin C24 (μg/L). | Maraviroc: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hour. Rifabutin: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hour.. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety/Tolerability of the Treatments | description and frequency of adverse events for all participants during the study. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald W Cameron, MD | The Ottawa Hospital, Ottawa Hospital Research Institute, University of Ottawa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital -General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31647836 | Result | Ghannad M, Dennehy M, la Porte C, Seguin I, Tardiff D, Mallick R, Sabri E, Zhang G, Kanji S, Cameron DW. A drug interaction study investigating the effect of Rifabutin on the pharmacokinetics of Maraviroc in healthy subjects. PLoS One. 2019 Oct 24;14(10):e0223969. doi: 10.1371/journal.pone.0223969. eCollection 2019. |
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The Clinical Investigation Unit (CIU) at the OHRI has a database of healthy volunteers interested in participating in clinical studies who were contacted and recruited by phone or email. The first patient was recruited on 06 Sept 2013 and the last follow-up visit was on 23 Dec 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Maraviroc | Two period pharmacokinetic drug-drug interaction Period one -Maraviroc alone; Period two -Maraviroc and Rifabutin Substance: Maraviroc (Celsentri, MVC) tablets, 300 mg; dose: oral, 300 mg (1 tablet) twice daily Substance: Rifabutin (mycobutin, RFB) capsules, 150 mg; dose: oral, 300 mg (2 capsules) once daily Rifabutin: Substance: Rifabutin Daily dose: oral, 300 mg once daily (8:00 am) for 10 days Maraviroc: Substance maraviroc daily dose 300 mg twice daily (8:00 am and 8:00 pm) for 15 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A single participant dropped out due to Nausea. This resulted in 14 participants Data only being analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Maraviroc | Two period pharmacokinetic drug-drug interaction Period one -Maraviroc alone; Period two -Maraviroc and Rifabutin Substance: Maraviroc (Celsentri, MVC) tablets, 300 mg; dose: oral, 300 mg (1 tablet) twice daily Substance: Rifabutin (mycobutin, RFB) capsules, 150 mg; dose: oral, 300 mg (2 capsules) once daily Rifabutin: Substance: Rifabutin Daily dose: oral, 300 mg once daily (8:00 am) for 10 days Maraviroc: Substance maraviroc daily dose 300 mg twice daily (8:00 am and 8:00 pm) for 15 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 15 patients underwent baseline measurements and allocated to intervention. However, only 14 were analyzed due to 1 participant withdrawing from the study due to Nausea. |
| 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 | Pharmacokinetics of Maraviroc and Rifabutin AUC 0-12/24 | Maraviroc pharmacokinetics: Maraviroc only AUC (h*μg/L), Maraviroc + Rifabutin AUC (h*μg/L), Rifabutin AUC (h*μg/L), 25-O-desacetyl rifabutin AUC (h*μg/L). | Posted | Geometric Mean | 90% Confidence Interval | h*μg/L | Maraviroc: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hour. Rifabutin: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hour.. |
|
30 days.
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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 | Maraviroc | Two period pharmacokinetic drug-drug interaction Period one -Maraviroc alone; Period two -Maraviroc and Rifabutin Substance: Maraviroc (Celsentri, MVC) tablets, 300 mg; dose: oral, 300 mg (1 tablet) twice daily Substance: Rifabutin (mycobutin, RFB) capsules, 150 mg; dose: oral, 300 mg (2 capsules) once daily Rifabutin: Substance: Rifabutin Daily dose: oral, 300 mg once daily (8:00 am) for 10 days Maraviroc: Substance maraviroc daily dose 300 mg twice daily (8:00 am and 8:00 pm) for 15 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Pain in the areas surrounding and in the joints. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bill Cameron | Ottawa Hospital Research Institute | 613-737-8899 | 78923 | bcameron@toh.ca |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D015270 | Mycobacterium avium-intracellulare Infection |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D017828 | Rifabutin |
| D000077592 | Maraviroc |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Maraviroc | Drug | Substance maraviroc daily dose 300 mg twice daily (8:00 am and 8:00 pm) for 15 days |
|
|
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | 15 patients underwent baseline measurements and allocated to intervention. However, only 14 were analyzed due to 1 participant withdrawing from the study due to Nausea. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Region in which study participants have been recruited. | Number | participants |
|
|
|
| Primary | Maraviroc and Rifabutin C12/C24/Cmax PK Concentrations in Plasma. | Maraviroc + Rifabutin pharmacokinetics: Maraviroc only Cmax (μg/L), Maraviroc only C12 (μg/L), Maraviroc + Rifabutin Cmax (μg/L), Maraviroc + Rifabutin C12 (μg/L), Rifabutin Cmax (μg/L), Rifabutin C24 (μg/L), 25-O-desacetyl rifabutin Cmax (μg/L), 25-O-desacetyl rifabutin C24 (μg/L). | Posted | Geometric Mean | 90% Confidence Interval | μg/L | Maraviroc: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hour. Rifabutin: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hour.. |
|
|
|
| Secondary | Safety/Tolerability of the Treatments | description and frequency of adverse events for all participants during the study. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 11 |
| 14 |
|
| Fever | General disorders | Systematic Assessment | Increase in body temperature above normal threshold. |
|
| Headache | Nervous system disorders | Systematic Assessment | Pain occurring in the head. |
|
| Muscle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Pain in the participants limb muscles, occasionally in the Torso. |
|
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009165 | Mycobacterium Infections, Nontuberculous |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
|
| Maraviroc + Rifabutin C12 (μg/L) |
|
| Rifabutin Cmax (μg/L) |
|
| Rifabutin C24 (μg/L) |
|
| 25-O-desacetyl rifabutin Cmax (μg/L) |
|
| 25-O-desacetyl rifabutin C24 (μg/L) |
|
| Number of Participants without Adverse Events |
|