| Primary | Maximum Observed Plasma Concentration (Cmax) for Daclatasvir | Cmax was obtained from concentration-time plot using a noncompartmental method and a validated pharmacokinetic analysis program. | All treated participants with adequate pharmacokinetic profiles. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2) | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Daclatasvir (60 mg) | Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4. | | OG001 | Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir | Participants received a 30-mg daclatasvir tablet once daily, along with an 800-mg darunavir tablet, and a 100-mg ritonavir capsule once daily on Days 5 through 14. | | OG002 | Group 2: Daclatasvir (60 mg) | Participants received a 60-mg daclatasvir tablet once daily on Days 5 through 14. | | OG003 | Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir | Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily Days 5 through 14. |
| | Units | Counts |
|---|
| Participants | - OG00014
- OG00111
- OG00214
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0001335± 38
- OG001493± 36
- OG0021412± 28
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax. | | | | | Adjusted Geometric Mean Ratio | 0.384 | | | 2-Sided | 90 | 0.348 | 0.423 | | | | No | Superiority or Other | | | | |
|
| Primary | Area Under the Concentration-Time Curve in 1 Dosing Interval (AUC[TAU]) for Daclatasvir | AUC(TAU) was the area under the curve from time zero to end of dosing interval. AUC(TAU) was obtained from concentration-time plot of daclatasvir using noncompartmental method and a validated pharmacokinetic analysis program. | All treated participants with adequate pharmacokinetic profiles. Number of participants analyzed (N) signifies number of participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | | Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2) | | | | ID | Title | Description |
|---|
| OG000 | Daclatasvir (60 mg) Days 1-4 | Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4. | | OG001 | Daclatasvir (30 mg) + Darunavir/Ritonavir Days 5-14 | Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14. | | OG002 | Daclatasvir (60 mg) Days 5-14 | Participants received a 60-mg daclatasvir tablet once daily on Days 5 through 14. |
|
| Secondary | Time of Maximum Observed Plasma Concentration (Tmax) of Daclatasvir | Tmax was obtained from concentration-time plot of daclatasvir by using non-compartmental method by a validated pharmacokinetic analysis program. | All treated participants with adequate pharmacokinetic profile. Here, N signifies number of participants evaluable for this outcome measure. | Posted | | Median | Full Range | hours | | Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2) | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Daclatasvir (60 mg) | Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4. | | OG001 | Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir | Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14. | | OG002 | Group 2: Daclatasvir (60 mg) | Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4. | | OG003 |
|
| Secondary | Plasma Concentration Observed at 24 Hours Postdose (C24) of Daclatasvir | C24 was obtained from concentration time plot of daclatasvir by using noncompartmental method by a validated pharmacokinetic analysis program. | All treated participants with adequate pharmacokinetic profile. Here, N signifies number of participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2) | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Daclatasvir (60 mg) | Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4. | | OG001 | Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir | Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14. | | OG002 | Group 2: Daclatasvir (60 mg) | Participants received 60 mg of daclatasvir tablet once daily from Day 1 through 4. | |
|
| Secondary | Dose-normalized Maximum Observed Plasma Concentration (Cmax/D) and Dose-normalized Plasma Concentration Observed at 24 Hours Postdose (C24/D) of Daclatasvir | Cmax/D and C24/D are obtained from concentration-time plot of daclatasvir by using noncompartmental method by a validated pharmacokinetic analysis program. | All treated participants with adequate pharmacokinetic profile. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL/mg | | Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2) | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Daclatasvir (60 mg) | Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4. | | OG001 | Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir | Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14. | | OG002 | Group 2: Daclatasvir (60 mg) | Participants received 60 mg of daclatasvir tablet once daily from Day 1 through 4. |
|
| Secondary | Dose-normalized Area Under the Concentration-Time Curve in 1 Dosing Interval (AUC[TAU]/D) of Daclatasvir | AUC(TAU)/D was obtained from concentration-time plot of daclatasvir by using noncompartmental method by a validated pharmacokinetic analysis program. | All treated participants with adequate pharmacokinetic profile. Here, N signifies number of participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (ng*h/mL)/mg | | Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2) | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Daclatasvir (60 mg) | Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4. | | OG001 | Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir | Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14. | | OG002 | Group 2: Daclatasvir (60 mg) | Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4. |
|
| Secondary | Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) and Who Died | AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. | All participants who received at least 1 dose of study drug | Posted | | Number | | participants | | From start of study treatment (Day 1) to study discharge for AEs (up to 15 days); Day 1 to 30 days after last dose of study treatment for SAEs (up to 44 days) | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Daclatasvir (60 mg) | Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4. | | OG001 | Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir | Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14. | | OG002 | Group 2: Daclatasvir (60 mg) | |
|
| Secondary | Number of Participants With Abnormalities in Vital Sign Measurements | Criteria for abnormalities in vital sign measurements: Diastolic blood pressure: Value >90 and change from baseline > 0 or value < 55 and change from baseline <-10. Systolic blood pressure: Value >140 and change from baseline >20 or value <90 and change from baseline <-20. Heart rate: Value >100 and change from baseline >30 or value <55 and change from baseline <-15. Respiration: Value >16 or change from baseline >10. Temperature: Value >38.3°C or change from baseline >1.6°C. | Participants who received at least 1 dose of study drug | Posted | | Number | | participants | | From start of study treatment (Day 1) to study discharge (up to 15 days) | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Daclatasvir + Darunavir/Ritonavir | Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14. | | OG001 | Group 2: Daclatasvir + Lopinavir/Ritonavir | Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14. |
| |
| Secondary | Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings | Abnormalities in ECG findings included: PR ≥210 msec, QRS ≥120 msec, QT ≥500 msec, QTcF ≥450 msec, and second- or third-degree heart block. | All participants who received at least 1 dose of study drug | Posted | | Number | | participants | | From start of study treatment (Day 1) to study discharge (up to 15 days) | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Daclatasvir (60 mg) | Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4. | | OG001 | Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir | Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and 100-mg ritonavir capsule once daily on Days 5 through 14. | | OG002 | Group 2: Daclatasvir (60 mg) | Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4. | | OG003 | Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir | Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/ 50-mg ritonavir tablets twice daily on Days 5 through 14. |
|
| Secondary | Number of Participants With Marked Abnormalities in Hematology Laboratory Test Results | Criteria for marked abnormalities in test results: Platelet count >1.5*upper limits of normal (ULN) value, >1.5*ULN if pretreatment (PreRx) value is missing, <0.85*lower limit of normal (LLN) if PreRx ≥LLN, <0.85*LLN if PreRx is missing, <0.85*PreRx if PreRx <LLN. Leukocytes >1.2*ULN if LLN ≤PreRx ≤ULN, >1.2*ULN if PreRx is missing, >1.5*PreRx if PreRx >ULN, >ULN if PreRx <LLN, <0.85*PreRx if PreRx <LLN, <0.9*LLN if LLN ≤PreRx ≤ULN, <0.9*LLN if PreRx is missing and <LLN if PreRx >ULN. Lymphocytes >7.5*10^3 c/uL and <0.75*10^3 c/uL. Neutrophils <0.85*PreRx if PreRx <1.5*ULN, <1.5*ULN if PreRx ≥1.5*ULN and <1.5*ULN if PreRx is missing. | All treated participants. | Posted | | Number | | participants | | From start of study treatment (Day 1) to study discharge (up to 15 days) | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Daclatasvir (60 mg) | Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4. | | OG001 | Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir | Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14. | | OG002 | Group 2: Daclatasvir (60 mg) |
|
| Secondary | Number of Participants With Abnormalities in Urinalysis and Other Chemistry Testing Results | Criteria for marked abnormalities on laboratory test results: urinary dipstick blood: ≥2 if pretreatment (PreRx) <1, ≥2 if PreRx is missing or ≥2*PreRx if PreRx ≥1. Urinary microscopic red blood cell (RBC): ≥2 if PreRx <2, ≥2 if PreRx is missing or ≥4 if PreRx ≥2. Urinary microscopic white blood cell (WBC): ≥2 if PreRx <2, ≥2 if PreRx is missing or ≥4 if PreRx ≥2. Lactate dehydrogenase >1.25*upper limit of normal (ULN) if PreRx ≤ULN, >1.25*ULN if PreRx is missing and >1.5*PreRx if PreRx >ULN. | All treated participants. | Posted | | Number | | participants | | From start of study treatment (Day 1) to study discharge (up to 15 days) | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Daclatasvir (60 mg) | Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4. | | OG001 | Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir | Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14. | | OG002 | Group 2: Daclatasvir (60 mg) | Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4. |
|