| Primary | Maximum Observed Plasma Concentration (Cmax) and Minimum Observed Plasma Concentration (Cmin) of Atazanavir, Administered as Atazanavir/Ritonavir With and Without Voriconazole, in Participants Who Are Extensive Metabolizers (EM) | EM participants are those with functional CYP2C19 alleles. | All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle | | | | ID | Title | Description |
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| OG000 | Atazanavir/Ritonavir, 300/100 QD (EM) | Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal. | | OG001 | Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM) | Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose. |
| | | Title | Denominators | Categories |
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| Atazanavir Cmin | | | Title | Measurements |
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| - OG000674± 61
- OG001525± 50
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| | Atazanavir Cmax | | |
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| Primary | Time to Maximum Concentration (Tmax) of Atazanavir, Administered as Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants | EM=extensive metabolizers, or participants with functional CYP2C19 alleles. | All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available. | Posted | | Median | Full Range | Hours | | Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle | | | | ID | Title | Description |
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| OG000 | Atazanavir/Ritonavir, 300/100 QD (EM) | Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal. | | OG001 | Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM) | Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose. |
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| Primary | Area Under the Plasma Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] of Atazanavir Administered as Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants | EM=extensive metabolizers, or participants with functional CYP2C19 alleles. | All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | | Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle | | | | ID | Title | Description |
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| OG000 | Atazanavir/Ritonavir, 300/100 QD (EM) | Treatment B: EMs received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal. | | OG001 | Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM) | Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose. |
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| Secondary | Cmax and Cmin of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants | Cmax=maximum observed plasma concentration; Cmin=minimum observed plasma concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles. | All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle | | | | ID | Title | Description |
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| OG000 | Atazanavir/Ritonavir, 300/100 QD (EM) | Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal. | | OG001 | Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM) | Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose. |
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| Secondary | Tmax of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants | Tmax=time to maximum concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles. | All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available. | Posted | | Median | Full Range | Hours | | Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle | | | | ID | Title | Description |
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| OG000 | Atazanavir/Ritonavir, 300/100 QD (EM) | Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal. | | OG001 | Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM) | Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose. |
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| Primary | Tmax of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants | Tmax=time to maximum concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles. | All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available. | Posted | | Median | Full Range | Hours | | Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle | | | | ID | Title | Description |
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| OG000 | Voriconazole, 200 BID (EM) | Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal. | | OG001 | Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM) | Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose. |
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| Primary | Cmax and Cmin of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants | Cmax=maximum observed plasma concentration; Cmin=minimum observed plasma concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles. | All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle | | | | ID | Title | Description |
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| OG000 | Voriconazole, 200 BID | Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal. | | OG001 | Atazanavir/Ritonavir, 300/100mg QD + Voriconazole, 200 mg BID | Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose. |
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| Primary | AUC(TAU)of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants | AUC(TAU)=area under the plasma concentration-time curve in 1 dosing interval; EM=extensive metabolizers, or participants with functional CYP2C19 alleles. | All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng.h/mL | | Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle | | | | ID | Title | Description |
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| OG000 | Voriconazole, 200 BID (EM) | Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal. | | OG001 | Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM) | Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose. |
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| Secondary | AUC(TAU) of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants | AUC(TAU)=area under the plasma concentration-time curve in 1 dosing interval; EM=extensive metabolizers, or participants with functional CYP2C19 alleles. | All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng.h/mL | | Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle | | | | ID | Title | Description |
|---|
| OG000 | Atazanavir/Ritonavir, 300/100 QD (EM) | Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal. | | OG001 | Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM) | Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose. |
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| Secondary | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Any AE | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. | All participants who received study drug. | Posted | | Number | | Participants | | Days 1 to 31 (discharge), continuously | | | | ID | Title | Description |
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| OG000 | Voriconazole, 200 BID (EM) | Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal. | | OG001 | Atazanavir/Ritonavir, 300/100 QD (EM) | Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal. | | OG002 | Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM) |
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| Secondary | Number of Participants With Marked Abnormalities in Serum Chemistry Test Results | LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Safety criteria: AST and ALT: If >1.25*ULN, or if preRX>ULN, use >1.25*preRX. Total and direct bilirubin: If >1.1*ULN or if preRX>ULN, use >1.25*preRX. Creatinine: If >1.33*preRX. Serum glucose, fasting: If preRX<LLN, use <.8*preRX or >ULN; if preRX>ULN, use >2*preRX or <LLN. Creatinine kinase: If >1.5*ULN or preRX>ULN, use >1.5*or preRX. Lactose dehydrogenase: If >1.25*ULN or preRX>ULN, use >1.5*preRX. | All participants who received study drug. | Posted | | Number | | Participants | | Within 21 days of Day 1 and on Days 3, 10, 20, 26, and 31 (at discharge) | | | | ID | Title | Description |
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| OG000 | Voriconazole, 200 BID (EM) | Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal. | | OG001 | Atazanavir/Ritonavir, 300/100 QD (EM) | Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal. | | OG002 | Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM) |
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| Secondary | Number of Participants With Marked Abnormalities in Hematology Laboratory Test and Urinalysis Results | LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Safety criteria: Neutrophils + bands: If <.85*LLN or >1.15*ULN or ULN or if preRX<LLN, use <0.85*preRX or >ULN; if preRX>ULN, use >1.15*preRX or <LLN. Lymphocytes, relative: If <0.85*LLN or >1.15*ULN, or if preRX <LLN, use <0.85*preRX or >ULN; if preRX >ULN, use >1.15*preRX or <LLN. Blood, urine: If >= 2+, or if preRX >=1+, use >=2*preRX. White blood cells, urine: If >=2+, or if preRX >=2+, use >=4+. Red blood cells, urine: If >=2+ or if preRX >=2+, use >=4+. Not all categories were evaluated for each arm. | All participants who received study drug. | Posted | | Number | | Participants | | Within 21 days of Day 1 and on Days 3, 10, 20, 26, and 31 (at discharge) | | | | ID | Title | Description |
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| OG000 | Voriconazole, 200 BID (EM) | Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal. | | OG001 | Atazanavir/Ritonavir, 300/100 QD (EM) | Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal. |
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| Secondary | Number of Participants With Investigator-identified Abnormalities in Electrocardiogram Results Not Present Prior to Administration of Study Drug and Considered Not Relevant and Not AEs by Investigator | volt=voltage; LVH=left ventricular hypertrophy | All participants who received study drug. | Posted | | Number | | Participants | | Within 21 days of Day 1 and on Days -1, 21, and 31 (at discharge) | | | | ID | Title | Description |
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| OG000 | Voriconazole, 200 BID (EM) | Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal. | | OG001 | Atazanavir/Ritonavir, 300/100 QD (EM) | Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal. | | OG002 | Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM) | Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose. |
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| Secondary | Number of Participants With Abnormalities in Vital Signs | | All participants who received study drug. | Posted | | Number | | Participants | | Within 21 days of Day 1 and on Days -1, 1, 3, 11, 21, and 31 (at discharge) | | | | ID | Title | Description |
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| OG000 | Voriconazole, 200 BID (EM) | Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal. | | OG001 | Atazanavir/Ritonavir, 300/100 QD (EM) | Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal. | | OG002 | Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM) | Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose. | | OG003 |
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