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The primary purpose of this study is to assess the change in Hepatitis C Virus RNA during dosing with daclatasvir and during the follow-up period in subjects with chronic hepatitis C infection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Daclatasvir (1 mg), once daily or Matching Placebo, once daily |
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| Group 2 | Active Comparator | Daclatasvir (10 mg), once daily or Matching Placebo, once daily |
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| Group 3 | Active Comparator | Daclatasvir (1-100 mg), once or twice daily or Matching Placebo, once or twice daily |
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| Group 4 | Active Comparator | Daclatasvir (1-100 mg), once or twice daily or Matching Placebo, once or twice daily |
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| Group 5 | Active Comparator | Group 5: Active Comparator Daclatasvir (1-100 mg), once or twice daily or Matching Placebo, once or twice daily |
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| Group 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir | Drug | Capsule, Oral, Approximately 182 days from initial dosing |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA of All Participants | The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1. | Baseline, Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA Levels of Participants Without Baseline Drug Resistance | The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 international units/ millilitre (IU/mL). Baseline was Day -1 | Baseline, Day 7 |
| Change From Baseline at 24 h Post Dose on Day 1 in log10 Hepatitis C Virus (HCV) RNA of Participants Without Baseline Drug Resistance |
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Inclusion Criteria:
Exclusion Criteria:
WOCBP will be enrolled as in-patient for 16 days
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Clinical Res Inst | Anaheim | California | 92801 | United States | ||
| West Coast Clinical Trials, Llc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21837752 | Derived | Nettles RE, Gao M, Bifano M, Chung E, Persson A, Marbury TC, Goldwater R, DeMicco MP, Rodriguez-Torres M, Vutikullird A, Fuentes E, Lawitz E, Lopez-Talavera JC, Grasela DM. Multiple ascending dose study of BMS-790052, a nonstructural protein 5A replication complex inhibitor, in patients infected with hepatitis C virus genotype 1. Hepatology. 2011 Dec;54(6):1956-65. doi: 10.1002/hep.24609. |
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A total of 30 participants received study treatment.
167 enrolled; 30 entered treatment Period. Reasons for not entering: 1 lost to follow-up, 4 withdrew consent, 5 administrative reasons, 6 other, 121 did not meet study criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Daclatasvir (1 mg) QD | Participants received once daily (QD) dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| FG001 | Daclatasvir (10 mg) QD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
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Group 6: Active Comparator Daclatasvir (1-100 mg), once or twice daily or Matching Placebo, once or twice daily |
|
| Placebo | Drug | Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel |
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The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1. |
| Baseline, 2, 4, 6, 8, 12, 16, 20, and 24 hours post dose on Day 1 |
| Change From Baseline to Day 4 in log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance | The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1. | Baseline to Day 4 |
| Change From Baseline to Day 14 in Log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance | The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1. | Baseline to Day 14 |
| Time to Maximum Decline From Baseline in Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance | Participants without baseline drug resistance were assessed for time to reach maximum decrease in log10 HCV RNA level. | Day 1 up to Day 14 |
| Maximum Decline From Baseline in Log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance | The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. | Day 1 up to Day 14 |
| Maximum Observed Plasma Concentration (Cmax) and Minimum Observed Plasma Concentration (Cmin) of Daclatasvir on Days 1 and 14 | The peak concentrations in plasma (Cmax) and minimum observed plasma concentration (Cmin) were defined as the peak maximum and minimum plasma level of daclatasvir, derived from plasma concentration-time data analyzed by non-compartmental methods. Cmax and Cmin of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method. | 0 hour (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13 and 24, 48 and 72 hours (post morning dose) at Day 14 |
| Area Under the Concentration-time Curve (AUC) in 1 Dosing Interval of Daclatasvir at Days 1 and 14 | The area under the concentration-time curve in 1 Dosing Interval AUC(TAU) was used to measure the drug exposure over 1 dosing interval., derived from plasma concentration-time data analyzed by non-compartmental methods. AUC(TAU) of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method. | 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14 |
| Plasma Half-life (T-half) of Daclatasvir at Day 14 | The absolute values of lamda (λ) were used to evaluate apparent terminal half-life (T-half) was defined as T-half= ln 2/λ. T-half was derived from plasma concentration-time data analyzed by non-compartmental methods. T-half of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method. | 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14 |
| Apparent Total Body Clearance (CLT/F) of Daclatasvir on Day 14 | The apparent total body clearance at steady state (CLT/F) was defined as the apparent body clearance of canakinumab from the serum when the systemic availability was unknown. CLT/F was derived from plasma concentration-time data analyzed by non-compartmental methods. CLT/F of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method. | 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14 |
| Average Observed Plasma Concentration (Css-av) at Steady State of Daclatasvir at Days 1 and 14 | The average observed plasma concentration at steady state (Css-av) was calculated as ratio of AUC(TAU) by TAU, where TAU = 24 h for QD dosing and 12 h for BID dosing. Css-av was derived from plasma concentration-time data analyzed by non-compartmental methods. Css-av of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method. | 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11,13, and 24, 48 and 72 hours (post morning dose) at Day 14 |
| Accumulation Index (AI) AUC(TAU), AI Cmax, and Degree of Fluctuation (DF) of Daclatasvir on Day 14 | Accumulation index area under the concentration-time curve of daclatasvir to the end of the dosing period [AI AUC(TAU)] was defined as the ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose.Accumulation index maximum observed concentration of daclatasvir in plasma (AI Cmax) was defined as the ratio of Cmax at steady-state to Cmax after the first dose. Degree of Fluctuation (DF) was defined as the ratio of difference between Cmax and Cmin at steady state by Css-av. The parameters were analyzed using non-compartmental methods, assayed by validated liquid chromatography tandem mass spectrometry (LC-MS/MS). | 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14 |
| Time of Maximum Observed Plasma Concentration (Tmax) of Daclatasvir on Days 1 and 14 | Tmax was defined as the time to reach maximum observed plasma concentration of daclatasvir in plasma. Tmax was derived from plasma concentration-time data analyzed by non-compartmental methods. Tmax of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method. | 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14 |
| Correlation Coefficients Between Measures of Decline in log10 Hepatitis C Virus (HCV) RNA and Daclatasvir PK Parameters Cmax, AUC(TAU), and Cmin on Day 14 in Participants Without Baseline Drug Resistance | Correlation between decline of log10 hepatitis C virus (HCV) RNA and exposure to study drug was measured by Pearson Correlation Coefficients. The change from baseline at Day 4 in log10 HCV RNA and the maximum decline in log10 HCV RNA were evaluated against the PK parameters Cmax, Cmin and AUC(TAU). | Day 4, Day 14 |
| Number of Participants With Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), and Who Died | 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. | Day 1 to Day 182 or Day of Discharge |
| Number of Participants With Marked Laboratory Abnormalities in Hematology | Hematology marked laboratory abnormalities were defined as Hemoglobin (g/dL) Low as < 0.85*Pre-therapy (PreRx), Hematocrit (%) Low as < 0.85*PreRx, Platelet Count *10^9 c/L Low as < 0.85*Lower Limits of Normal (LLN) if PreRx = Missing/< 0.85*LLN if PreRx >= LLN/< 0.85*PreRx if PreRx < LLN, Eosinophils (absolute) *10^3 c/µL High as > 0.75*count, Leukocytes White Blood Cell (WBC) *10^3 c/µL High as > 1.2*ULN if LLN <= PreRx <= Upper Limits of Normal (ULN) > 1.2*ULN if PreRx = Missing/> 1.5*PreRx if PreRx > ULN/> ULN if PreRx < LLN. | Screening, Day 3, Day 7, Day 11, Day 14, and Day 28 |
| Number of Participants With Marked Abnormalities in Liver and Kidney Function Laboratory Tests and Electrolytes | Liver and kidney function marked laboratory abnormalities were defined as Alanine Aminotransferase (ALT) units per liter (U/L) High as > 1.25*PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, Aspartate Aminotransferase (AST) U/L High as > 1.25* PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, Alkaline Phosphatase(ALP)U/L High as > 1.25*PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, G-Glutamyl Transferase (GGT) in U/L High as >1.15*ULN if PreRx<=ULN/>1.15* if PreRx missing/>1.2* PreRx if PreRx>ULN, Phosphorus Inorganic (mg/dL) Low as < 0.85*LLN if LLN <= PreRx <= ULN/< 0.85*LLN if PreRx = Missing/< 0.85*PreRx if PreRx < LLN/< LLN if PreRx > ULN, and Potassium serum milliequivalents per liter (mEq/L) High as > 1.1*PreRx if PreRx > ULN/> 1.1*ULN if LLN <= PreRx <= ULN/> 1.1*ULN if PreRx = Missing/> ULN if PreRx < LLN. | Screening, Day 3, Day 7, Day 11, Day 14, and Day 28 |
| Number of Participants With Marked Laboratory Abnormalities in Lipase and Glucose | Marked abnormalities were defined as Lipase (U/L) High as >1.5*ULN, Glucose fasting serum (mg/dL) High as > 1.3*ULN if LLN <= PreRx <= ULN/> 1.3*ULN if PreRx = Missing/>2*PreRx; if PreRx > ULN/> ULN if PreRx < LLN. | Screening, Day 3, Day 7, Day 11, Day 14, and Day 28 |
| Number of Participants With Marked Laboratory Abnormalities in Urinalysis | Marked laboratory abnormalities in urinalysis were defined as, Blood Urine High as >= 2*PreRx if PreRx >= 1/>= 2 if PreRx < 1/>= 2 if PreRx = Missing. Glucose Urine High as >= 1 if PreRx < 1/>= 1 if PreRx = Missing/>= 2*PreRx if PreRx >= 1. | Screening, Day 3, Day 7, Day 11, Day 14, and Day 28 |
| Number of Participants With Clinically Relevant Change From Baseline in Vital Signs | Vital signs included: body temperature, respiratory rate, blood pressure (systolic and diastolic) and heart rate. Blood pressure and heart rate were measured after the participant had been supine, semi-supine, or seated quietly for at least 5 minutes. Baseline was defined as the last observation prior to dosing on Day 1. | Screening, Day -1 and prior to morning dose on Day 1, 2, 14, and 28 |
| Number of Participants Meeting Pre-Specified Criteria in Electrocardiogram Parameters | Pre-specified criteria were defined as, Heart rate (HR) minimum as <=50 bpm/change from baseline <-20 bpm/maximum HR >100 bpm, QT interval corrected using Fridericia's formula (QTcF) maximum as QTcF<=450 msec/450 msec <maximum QTcF and <=480 msec/480 msec <maximum QTcF <= 500 msec/maximum QTcF>500 msec, QRS interval as <=120 msec/>120 msec, and PR interval maximum as <= 200 msec/>200 msec. | Screening, Day 2, 3, 5, 7, 9, 11, 13, 15, 21 and 28 |
| Cypress |
| California |
| 90630 |
| United States |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States |
| Elite Research Institute | Miami | Florida | 33169 | United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| Parexel International Corporation | Baltimore | Maryland | 21225 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Local Institution | Santurce | 00909 | Puerto Rico |
Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| FG002 | Daclatasvir (30 mg) QD | Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| FG003 | Daclatasvir (60 mg) QD | Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| FG004 | Daclatasvir (30 mg) BID | Participants received twice daily (BID) dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| FG005 | Daclatasvir (100 mg) QD | Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| FG006 | Placebo | Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel. |
| COMPLETED |
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| NOT COMPLETED |
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| Follow-up Period |
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The analysis was performed on all treated participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Daclatasvir (1 mg) QD | Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| BG001 | Daclatasvir (10 mg) QD | Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| BG002 | Daclatasvir (30 mg) QD | Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| BG003 | Daclatasvir (60 mg) QD | Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| BG004 | Daclatasvir (30 mg) BID | Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| BG005 | Daclatasvir (100 mg) QD | Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| BG006 | Placebo | Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||
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| Secondary | Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA Levels of Participants Without Baseline Drug Resistance | The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 international units/ millilitre (IU/mL). Baseline was Day -1 | All randomized participants who took at least 1 dose of study medication. | Posted | Mean | 90% Confidence Interval | log10 IU/mL | Baseline, Day 7 |
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| Primary | Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA of All Participants | The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1. | All randomized participants who took at least 1 dose of study medication. | Posted | Mean | 90% Confidence Interval | log10 IU/mL | Baseline, Day 7 |
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| Secondary | Change From Baseline at 24 h Post Dose on Day 1 in log10 Hepatitis C Virus (HCV) RNA of Participants Without Baseline Drug Resistance | The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1. | All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations were summarized. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline, 2, 4, 6, 8, 12, 16, 20, and 24 hours post dose on Day 1 |
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| Secondary | Change From Baseline to Day 4 in log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance | The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1. | All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations. | Posted | Mean | 90% Confidence Interval | log10 IU/mL | Baseline to Day 4 |
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| Secondary | Change From Baseline to Day 14 in Log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance | The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1. | All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations. | Posted | Mean | 90% Confidence Interval | log10 IU/mL | Baseline to Day 14 |
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| Secondary | Time to Maximum Decline From Baseline in Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance | Participants without baseline drug resistance were assessed for time to reach maximum decrease in log10 HCV RNA level. | All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations. | Posted | Mean | Standard Deviation | Days | Day 1 up to Day 14 |
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| Secondary | Maximum Decline From Baseline in Log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance | The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. | All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations. | Posted | Mean | Standard Deviation | log10 IU/mL | Day 1 up to Day 14 |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) and Minimum Observed Plasma Concentration (Cmin) of Daclatasvir on Days 1 and 14 | The peak concentrations in plasma (Cmax) and minimum observed plasma concentration (Cmin) were defined as the peak maximum and minimum plasma level of daclatasvir, derived from plasma concentration-time data analyzed by non-compartmental methods. Cmax and Cmin of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method. | All participants who received at least 1 dose of study medication and with available Pharmacokinetic (PK) data were summarized. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliters(ng/mL) | 0 hour (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13 and 24, 48 and 72 hours (post morning dose) at Day 14 |
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| Secondary | Area Under the Concentration-time Curve (AUC) in 1 Dosing Interval of Daclatasvir at Days 1 and 14 | The area under the concentration-time curve in 1 Dosing Interval AUC(TAU) was used to measure the drug exposure over 1 dosing interval., derived from plasma concentration-time data analyzed by non-compartmental methods. AUC(TAU) of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method. | All participants who received at least 1 dose of study medication and with available PK data were summarized. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14 |
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| Secondary | Plasma Half-life (T-half) of Daclatasvir at Day 14 | The absolute values of lamda (λ) were used to evaluate apparent terminal half-life (T-half) was defined as T-half= ln 2/λ. T-half was derived from plasma concentration-time data analyzed by non-compartmental methods. T-half of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method. | All participants who received at least 1 dose of study medication and with available PK data were summarized. | Posted | Mean | Standard Deviation | h | 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14 |
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| Secondary | Apparent Total Body Clearance (CLT/F) of Daclatasvir on Day 14 | The apparent total body clearance at steady state (CLT/F) was defined as the apparent body clearance of canakinumab from the serum when the systemic availability was unknown. CLT/F was derived from plasma concentration-time data analyzed by non-compartmental methods. CLT/F of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method. | All participants who received at least 1 dose of study medication and with available PK data were summarized. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/min | 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14 |
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| Secondary | Average Observed Plasma Concentration (Css-av) at Steady State of Daclatasvir at Days 1 and 14 | The average observed plasma concentration at steady state (Css-av) was calculated as ratio of AUC(TAU) by TAU, where TAU = 24 h for QD dosing and 12 h for BID dosing. Css-av was derived from plasma concentration-time data analyzed by non-compartmental methods. Css-av of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method. | All participants who received at least 1 dose of study medication and with available PK data were summarized. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11,13, and 24, 48 and 72 hours (post morning dose) at Day 14 |
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| Secondary | Accumulation Index (AI) AUC(TAU), AI Cmax, and Degree of Fluctuation (DF) of Daclatasvir on Day 14 | Accumulation index area under the concentration-time curve of daclatasvir to the end of the dosing period [AI AUC(TAU)] was defined as the ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose.Accumulation index maximum observed concentration of daclatasvir in plasma (AI Cmax) was defined as the ratio of Cmax at steady-state to Cmax after the first dose. Degree of Fluctuation (DF) was defined as the ratio of difference between Cmax and Cmin at steady state by Css-av. The parameters were analyzed using non-compartmental methods, assayed by validated liquid chromatography tandem mass spectrometry (LC-MS/MS). | All participants who received at least 1 dose of study medication and with available PK data were summarized. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14 |
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| Secondary | Time of Maximum Observed Plasma Concentration (Tmax) of Daclatasvir on Days 1 and 14 | Tmax was defined as the time to reach maximum observed plasma concentration of daclatasvir in plasma. Tmax was derived from plasma concentration-time data analyzed by non-compartmental methods. Tmax of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method. | All participants who received at least 1 dose of study medication and with available PK data were summarized. | Posted | Median | Full Range | h | 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Correlation Coefficients Between Measures of Decline in log10 Hepatitis C Virus (HCV) RNA and Daclatasvir PK Parameters Cmax, AUC(TAU), and Cmin on Day 14 in Participants Without Baseline Drug Resistance | Correlation between decline of log10 hepatitis C virus (HCV) RNA and exposure to study drug was measured by Pearson Correlation Coefficients. The change from baseline at Day 4 in log10 HCV RNA and the maximum decline in log10 HCV RNA were evaluated against the PK parameters Cmax, Cmin and AUC(TAU). | All participants who received at least 1 dose of daclatasvir and who had no baseline genotype resistance were analyzed. Placebo participants were excluded from this analysis. | Posted | Number | Correlation Coefficient | Day 4, Day 14 |
|
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), and Who Died | 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 were summarized. | Posted | Number | participants | Day 1 to Day 182 or Day of Discharge |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Marked Laboratory Abnormalities in Hematology | Hematology marked laboratory abnormalities were defined as Hemoglobin (g/dL) Low as < 0.85*Pre-therapy (PreRx), Hematocrit (%) Low as < 0.85*PreRx, Platelet Count *10^9 c/L Low as < 0.85*Lower Limits of Normal (LLN) if PreRx = Missing/< 0.85*LLN if PreRx >= LLN/< 0.85*PreRx if PreRx < LLN, Eosinophils (absolute) *10^3 c/µL High as > 0.75*count, Leukocytes White Blood Cell (WBC) *10^3 c/µL High as > 1.2*ULN if LLN <= PreRx <= Upper Limits of Normal (ULN) > 1.2*ULN if PreRx = Missing/> 1.5*PreRx if PreRx > ULN/> ULN if PreRx < LLN. | All participants treated with study drug were summarized. | Posted | Number | participants | Screening, Day 3, Day 7, Day 11, Day 14, and Day 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Marked Abnormalities in Liver and Kidney Function Laboratory Tests and Electrolytes | Liver and kidney function marked laboratory abnormalities were defined as Alanine Aminotransferase (ALT) units per liter (U/L) High as > 1.25*PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, Aspartate Aminotransferase (AST) U/L High as > 1.25* PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, Alkaline Phosphatase(ALP)U/L High as > 1.25*PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, G-Glutamyl Transferase (GGT) in U/L High as >1.15*ULN if PreRx<=ULN/>1.15* if PreRx missing/>1.2* PreRx if PreRx>ULN, Phosphorus Inorganic (mg/dL) Low as < 0.85*LLN if LLN <= PreRx <= ULN/< 0.85*LLN if PreRx = Missing/< 0.85*PreRx if PreRx < LLN/< LLN if PreRx > ULN, and Potassium serum milliequivalents per liter (mEq/L) High as > 1.1*PreRx if PreRx > ULN/> 1.1*ULN if LLN <= PreRx <= ULN/> 1.1*ULN if PreRx = Missing/> ULN if PreRx < LLN. | All participants who were treated with study drug were summarized. | Posted | Number | participants | Screening, Day 3, Day 7, Day 11, Day 14, and Day 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Marked Laboratory Abnormalities in Lipase and Glucose | Marked abnormalities were defined as Lipase (U/L) High as >1.5*ULN, Glucose fasting serum (mg/dL) High as > 1.3*ULN if LLN <= PreRx <= ULN/> 1.3*ULN if PreRx = Missing/>2*PreRx; if PreRx > ULN/> ULN if PreRx < LLN. | All participants treated with study drug were summarized. | Posted | Number | participants | Screening, Day 3, Day 7, Day 11, Day 14, and Day 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Marked Laboratory Abnormalities in Urinalysis | Marked laboratory abnormalities in urinalysis were defined as, Blood Urine High as >= 2*PreRx if PreRx >= 1/>= 2 if PreRx < 1/>= 2 if PreRx = Missing. Glucose Urine High as >= 1 if PreRx < 1/>= 1 if PreRx = Missing/>= 2*PreRx if PreRx >= 1. | All participants treated with study drug were summarized. | Posted | Number | participants | Screening, Day 3, Day 7, Day 11, Day 14, and Day 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Relevant Change From Baseline in Vital Signs | Vital signs included: body temperature, respiratory rate, blood pressure (systolic and diastolic) and heart rate. Blood pressure and heart rate were measured after the participant had been supine, semi-supine, or seated quietly for at least 5 minutes. Baseline was defined as the last observation prior to dosing on Day 1. | All participants treated with study drug were summarized. | Posted | Number | participants | Screening, Day -1 and prior to morning dose on Day 1, 2, 14, and 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Meeting Pre-Specified Criteria in Electrocardiogram Parameters | Pre-specified criteria were defined as, Heart rate (HR) minimum as <=50 bpm/change from baseline <-20 bpm/maximum HR >100 bpm, QT interval corrected using Fridericia's formula (QTcF) maximum as QTcF<=450 msec/450 msec <maximum QTcF and <=480 msec/480 msec <maximum QTcF <= 500 msec/maximum QTcF>500 msec, QRS interval as <=120 msec/>120 msec, and PR interval maximum as <= 200 msec/>200 msec. | All participants treated with study drug were summarized. | Posted | Number | participants | Screening, Day 2, 3, 5, 7, 9, 11, 13, 15, 21 and 28 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Daclatasvir (1 mg) QD | Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received Daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. | 0 | 4 | 1 | 4 | ||
| EG001 | Daclatasvir (10 mg) QD | Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. | 0 | 4 | 4 | 4 | ||
| EG002 | Daclatasvir (100 mg) QD | Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. | 0 | 4 | 2 | 4 | ||
| EG003 | Daclatasvir (30 mg) BID | Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. | 0 | 4 | 2 | 4 | ||
| EG004 | Daclatasvir (30 mg) QD | Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. | 0 | 4 | 3 | 4 | ||
| EG005 | Daclatasvir (60 mg) QD | Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. | 0 | 4 | 4 | 4 | ||
| EG006 | Placebo | Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel. | 0 | 6 | 4 | 6 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Urethritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Energy increased | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Electrocardiogram T wave abnormal | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Tongue injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C549273 | daclatasvir |
Not provided
Not provided
Not provided
| Other reason |
|
| Male |
|
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG004 | Daclatasvir (30 mg) BID | Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG005 | Daclatasvir (100 mg) QD | Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG006 | Placebo | Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel. |
|
|
| OG003 | Daclatasvir (60 mg) QD | Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.. |
| OG004 | Daclatasvir (30 mg) BID | Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG005 | Daclatasvir (100 mg) QD | Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG006 | Placebo | Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel. |
|
|
| Daclatasvir (60 mg) QD |
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG004 | Daclatasvir (30 mg) BID | Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG005 | Daclatasvir (100 mg) QD | Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG006 | Placebo | Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel. |
|
|
| Daclatasvir (60 mg) QD |
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG004 | Daclatasvir (30 mg) BID | Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG005 | Daclatasvir (100 mg) QD | Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG006 | Placebo | Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel. |
|
|
| Daclatasvir (60 mg) QD |
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG004 | Daclatasvir (30 mg) BID | Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG005 | Daclatasvir (100 mg) QD | Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG006 | Placebo | Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel. |
|
|
| Daclatasvir (60 mg) QD |
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG004 | Daclatasvir (30 mg) BID | Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG005 | Daclatasvir (100 mg) QD | Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG006 | Placebo | Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel. |
|
|
| OG002 |
| Daclatasvir (30 mg) QD |
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG003 | Daclatasvir (60 mg) QD | Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG004 | Daclatasvir (30 mg) BID | Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG005 | Daclatasvir (100 mg) QD | Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
|
|
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG003 | Daclatasvir (60 mg) QD | Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG004 | Daclatasvir (30 mg) BID | Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG005 | Daclatasvir (100 mg) QD | Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
|
|
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
| OG003 | Daclatasvir (60 mg) QD | Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG004 | Daclatasvir (30 mg) BID | Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG005 | Daclatasvir (100 mg) QD | Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
|
|
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG003 | Daclatasvir (60 mg) QD | Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG004 | Daclatasvir (30 mg) BID | Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG005 | Daclatasvir (100 mg) QD | Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
|
|
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG003 | Daclatasvir (60 mg) QD | Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG004 | Daclatasvir (30 mg) BID | Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG005 | Daclatasvir (100 mg) QD | Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
|
|
| OG002 | Daclatasvir (30 mg) QD | Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG003 | Daclatasvir (60 mg) QD | Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG004 | Daclatasvir (30 mg) BID | Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG005 | Daclatasvir (100 mg) QD | Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
|
|
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
| OG003 | Daclatasvir (60 mg) QD | Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG004 | Daclatasvir (30 mg) BID | Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG005 | Daclatasvir (100 mg) QD | Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
|
|
|
| OG003 | Daclatasvir (60 mg) QD | Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG004 | Daclatasvir (30 mg) BID | Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG005 | Daclatasvir (100 mg) QD | Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG006 | Placebo | Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel. |
|
|
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
| OG003 | Daclatasvir (60 mg) QD | Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG004 | Daclatasvir (30 mg) BID | Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG005 | Daclatasvir (100 mg) QD | Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG006 | Placebo | Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel. |
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Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
| OG002 | Daclatasvir (30 mg) QD | Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG003 | Daclatasvir (60 mg) QD | Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG004 | Daclatasvir (30 mg) BID | Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG005 | Daclatasvir (100 mg) QD | Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG006 | Placebo | Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel. |
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| OG003 |
| Daclatasvir (60 mg) QD |
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG004 | Daclatasvir (30 mg) BID | Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG005 | Daclatasvir (100 mg) QD | Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG006 | Placebo | Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel. |
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| OG003 |
| Daclatasvir (60 mg) QD |
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG004 | Daclatasvir (30 mg) BID | Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG005 | Daclatasvir (100 mg) QD | Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG006 | Placebo | Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel. |
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| OG003 | Daclatasvir (60 mg) QD | Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG004 | Daclatasvir (30 mg) BID | Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG005 | Daclatasvir (100 mg) QD | Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG006 | Placebo | Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel. |
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| OG003 | Daclatasvir (60 mg) QD | Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG004 | Daclatasvir (30 mg) BID | Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG005 | Daclatasvir (100 mg) QD | Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. |
| OG006 | Placebo | Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel. |
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