Trial Outcomes & Findings for Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment (NCT NCT01830205)

NCT ID: NCT01830205

Last Updated: 2015-11-16

Results Overview

AUC(INF) was estimated by summing the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and the extrapolated area, computed by the quotient of the last observable concentration and elimination rate constant. The pharmacokinetic (PK) analysis was based on Cockcroft-Gault (C-G) creatinine clearance (CLcr) grouping method: normal renal function, end stage renal disease (ESRD), moderate and severe renal impairment. Mild participants were counted as per their original allocation.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 58 participants
• Primary outcome timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
• Results posted on: 2015-11-16

Participant Flow

The study was conducted at 2 centers in United States of America.

A total of 58 participants were enrolled and 36 were treated with study drug. Remaining 22 were not treated (14 no longer met study criteria, 4 other reasons, 2 administrative reasons and 2 withdrew consent). Participants were grouped by Cockcroft-Gault creatine clearance method for primary analysis.

Participant milestones

Measure	Normal Renal Function/Mild Renal Impairment Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \>=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had estimated glomerular filtration rate (eGFR) 60-89 mL/min per 1.73 m\^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.	Mild/Moderate Renal Impairment Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m\^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.	Mild/Severe Renal Impairment Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m\^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.	End Stage Renal Disease Participants with end stage renal disease and had eGFR \<15 mL/ min per 1.73 m\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
Overall Study STARTED	12	6	6	12
Overall Study COMPLETED	12	6	6	12
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment

Baseline characteristics by cohort

Measure	Normal Renal Function/Mild Renal Impairment n=12 Participants Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \>=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m\^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.	Mild/Moderate Renal Impairment n=6 Participants Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m\^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.	Mild/Severe Renal Impairment n=6 Participants Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m\^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.	End Stage Renal Disease n=12 Participants Participants with end stage renal disease and had eGFR \<15 mL/ min per 1.73 m\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Total n=36 Participants Total of all reporting groups
Age, Continuous	48.6 years STANDARD_DEVIATION 8.5 • n=5 Participants	62.0 years STANDARD_DEVIATION 12.6 • n=7 Participants	66.3 years STANDARD_DEVIATION 9.9 • n=5 Participants	49.0 years STANDARD_DEVIATION 11.7 • n=4 Participants	53.9 years STANDARD_DEVIATION 12.6 • n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants	30 Participants n=21 Participants
Region of Enrollment United States	12 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	12 participants n=4 Participants	36 participants n=21 Participants

PRIMARY outcome

Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose

Population: PK data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on the C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.

AUC(INF) was estimated by summing the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and the extrapolated area, computed by the quotient of the last observable concentration and elimination rate constant. The pharmacokinetic (PK) analysis was based on Cockcroft-Gault (C-G) creatinine clearance (CLcr) grouping method: normal renal function, end stage renal disease (ESRD), moderate and severe renal impairment. Mild participants were counted as per their original allocation.

Outcome measures

Measure	Normal Renal Function n=11 Participants Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Mild Renal Impairment n=4 Participants Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Moderate Renal Impairment n=5 Participants Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Severe Renal Impairment n=6 Participants Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	End Stage Renal Disease n=10 Participants Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \< 15 mL/ min per 1.73 m\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Daclatasvir	11215.264 nanograms*hours/milliliter (ng*h/mL) Geometric Coefficient of Variation 40	21261.199 nanograms*hours/milliliter (ng*h/mL) Geometric Coefficient of Variation 62	24789.951 nanograms*hours/milliliter (ng*h/mL) Geometric Coefficient of Variation 35	21946.450 nanograms*hours/milliliter (ng*h/mL) Geometric Coefficient of Variation 39	14257.489 nanograms*hours/milliliter (ng*h/mL) Geometric Coefficient of Variation 25

SECONDARY outcome

Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose

Population: Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.

AUC(INF)u was calculated by multiplying the area under the plasma concentration-time curve from time zero extrapolated to infinite time by mean fraction of unbound drug from 1 hour post-dose time point.

Outcome measures

Measure	Normal Renal Function n=11 Participants Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Mild Renal Impairment n=4 Participants Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Moderate Renal Impairment n=5 Participants Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Severe Renal Impairment n=6 Participants Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	End Stage Renal Disease n=10 Participants Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \< 15 mL/ min per 1.73 m\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
Unbound Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity Time (AUC(INF)u) of Daclatasvir	83.845 ng*h/mL Geometric Coefficient of Variation 37	128.157 ng*h/mL Geometric Coefficient of Variation 41	144.915 ng*h/mL Geometric Coefficient of Variation 13	139.576 ng*h/mL Geometric Coefficient of Variation 43	100.736 ng*h/mL Geometric Coefficient of Variation 31

SECONDARY outcome

Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose

Population: Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.

Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. The plasma samples were analyzed for daclatasvir by using a validated liquid chromatography tandem mass spectrometric (LC-MS/MS) assay.

Outcome measures

Measure	Normal Renal Function n=11 Participants Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Mild Renal Impairment n=4 Participants Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Moderate Renal Impairment n=5 Participants Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Severe Renal Impairment n=6 Participants Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	End Stage Renal Disease n=10 Participants Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \< 15 mL/ min per 1.73 m\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
Maximum Observed Plasma Concentration (Cmax) of Daclatasvir	1111.497 ng/mL Geometric Coefficient of Variation 39	1619.572 ng/mL Geometric Coefficient of Variation 13	1745.845 ng/mL Geometric Coefficient of Variation 31	1207.137 ng/mL Geometric Coefficient of Variation 33	1085.344 ng/mL Geometric Coefficient of Variation 15

SECONDARY outcome

Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose

Population: Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.

Unbound Maximum observed plasma concentrations (Cmaxu) was calculated by multiplying maximum observed plasma concentrations by mean fraction of unbound drug from 1 hour post-dose time point.

Outcome measures

Measure	Normal Renal Function n=11 Participants Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Mild Renal Impairment n=4 Participants Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Moderate Renal Impairment n=5 Participants Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Severe Renal Impairment n=6 Participants Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	End Stage Renal Disease n=10 Participants Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \< 15 mL/ min per 1.73 m\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
Unbound Maximum Observed Plasma Concentrations of Daclatasvir	8.309 ng/mL Geometric Coefficient of Variation 34	9.762 ng/mL Geometric Coefficient of Variation 14	10.206 ng/mL Geometric Coefficient of Variation 20	7.677 ng/mL Geometric Coefficient of Variation 33	7.668 ng/mL Geometric Coefficient of Variation 36

SECONDARY outcome

Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose

Population: Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.

AUC(0-T) was calculated as the sum of linear trapezoids using non-compartmental analysis.

Outcome measures

Measure	Normal Renal Function n=11 Participants Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Mild Renal Impairment n=4 Participants Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Moderate Renal Impairment n=5 Participants Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Severe Renal Impairment n=6 Participants Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	End Stage Renal Disease n=10 Participants Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \< 15 mL/ min per 1.73 m\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration [AUC(0-T)] of Daclatasvir	11092.967 ng*hour (h)/mL Geometric Coefficient of Variation 40	20852.129 ng*hour (h)/mL Geometric Coefficient of Variation 60	24343.711 ng*hour (h)/mL Geometric Coefficient of Variation 36	21238.909 ng*hour (h)/mL Geometric Coefficient of Variation 37	13934.562 ng*hour (h)/mL Geometric Coefficient of Variation 25

SECONDARY outcome

Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose

Population: Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.

Tmax was defined as the time required to reach maximum observed plasma concentration. Tmax was directly determined from the raw plasma concentration-time data.

Outcome measures

Measure	Normal Renal Function n=11 Participants Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Mild Renal Impairment n=4 Participants Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Moderate Renal Impairment n=5 Participants Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Severe Renal Impairment n=6 Participants Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	End Stage Renal Disease n=10 Participants Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \< 15 mL/ min per 1.73 m\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Daclatasvir	1.000 hours Interval 1.0 to 2.0	1.250 hours Interval 1.0 to 1.5	1.000 hours Interval 1.0 to 2.0	1.500 hours Interval 1.0 to 3.0	1.250 hours Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose

Population: Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.

Terminal half-life was the time required for one half of the total amount of administered drug eliminated from the body.

Outcome measures

Measure	Normal Renal Function n=11 Participants Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Mild Renal Impairment n=4 Participants Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Moderate Renal Impairment n=5 Participants Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Severe Renal Impairment n=6 Participants Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	End Stage Renal Disease n=10 Participants Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \< 15 mL/ min per 1.73 m\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
Plasma Half-life (T-half) of Daclatasvir	13.625 hours Geometric Coefficient of Variation 25	15.661 hours Geometric Coefficient of Variation 31	16.912 hours Geometric Coefficient of Variation 19	20.224 hours Geometric Coefficient of Variation 24	15.678 hours Geometric Coefficient of Variation 37

SECONDARY outcome

Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose

Population: Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.

Apparent total body clearance was calculated by dividing the dose by area under the plasma concentration-time curve from time zero extrapolated to infinite time.

Outcome measures

Measure	Normal Renal Function n=11 Participants Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Mild Renal Impairment n=4 Participants Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Moderate Renal Impairment n=5 Participants Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Severe Renal Impairment n=6 Participants Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	End Stage Renal Disease n=10 Participants Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \< 15 mL/ min per 1.73 m\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
Apparent Total Body Clearance (CLT/F) of Daclatasvir	89.164 milliliter/minute (mL/min) Geometric Coefficient of Variation 26	47.034 milliliter/minute (mL/min) Geometric Coefficient of Variation 43	40.339 milliliter/minute (mL/min) Geometric Coefficient of Variation 27	45.565 milliliter/minute (mL/min) Geometric Coefficient of Variation 31	70.139 milliliter/minute (mL/min) Geometric Coefficient of Variation 33

SECONDARY outcome

Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose

Population: Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.

The CLU/F was calculated by dividing the apparent total body clearance by mean fraction of unbound drug from 1 hour post dose time point.

Outcome measures

Measure	Normal Renal Function n=11 Participants Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Mild Renal Impairment n=4 Participants Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Moderate Renal Impairment n=5 Participants Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Severe Renal Impairment n=6 Participants Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	End Stage Renal Disease n=10 Participants Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \< 15 mL/ min per 1.73 m\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
Unbound Apparent Clearance (CLU/F) of Daclatasvir	11926.796 mL/min Geometric Coefficient of Variation 53	7802.955 mL/min Geometric Coefficient of Variation 33	6900.602 mL/min Geometric Coefficient of Variation 13	7164.575 mL/min Geometric Coefficient of Variation 41	9926.962 mL/min Geometric Coefficient of Variation 35

SECONDARY outcome

Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose

Population: Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=3), moderate (n=5) and severe renal impairment (n=5). Mild participants (n=4) are also counted as per their original allocation.

The percentage of daclatasvir recovered in the urine was determined by using validated liquid chromatography-tandem mass spectrometry methods. The sum of the percentage of dose recovered in urine from all intervals was calculated to obtain the total percentage of urinary excretion.

Outcome measures

Measure	Normal Renal Function n=11 Participants Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Mild Renal Impairment n=4 Participants Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Moderate Renal Impairment n=5 Participants Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Severe Renal Impairment n=5 Participants Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	End Stage Renal Disease n=3 Participants Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \< 15 mL/ min per 1.73 m\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
Percent Urinary Recovery (%UR) of Daclatasvir	5.007 Percentage of daclatasvir recovered Geometric Coefficient of Variation 36	5.820 Percentage of daclatasvir recovered Geometric Coefficient of Variation 27	3.530 Percentage of daclatasvir recovered Geometric Coefficient of Variation 40	2.658 Percentage of daclatasvir recovered Geometric Coefficient of Variation 58	0.199 Percentage of daclatasvir recovered Geometric Coefficient of Variation 131

SECONDARY outcome

Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose

Population: Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=3), moderate (n=5) and severe renal impairment (n=5). Mild participants (n=4) are also counted as per their original allocation.

The CLR was calculated by dividing the total amount excreted in the urine from 0 to 96 hours by the area under the plasma concentration-time curve from time zero extrapolated to infinite time.

Outcome measures

Measure	Normal Renal Function n=11 Participants Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Mild Renal Impairment n=4 Participants Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Moderate Renal Impairment n=5 Participants Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Severe Renal Impairment n=5 Participants Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	End Stage Renal Disease n=3 Participants Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \< 15 mL/ min per 1.73 m\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
Renal Clearance (CLR) of Daclatasvir	4.465 mL/min Geometric Coefficient of Variation 29	2.737 mL/min Geometric Coefficient of Variation 28	1.424 mL/min Geometric Coefficient of Variation 48	1.165 mL/min Geometric Coefficient of Variation 37	0.147 mL/min Geometric Coefficient of Variation 114

SECONDARY outcome

Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose

Population: Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.

The Vd/F was calculated by dividing the product of the dose and mean residence time by area under the plasma concentration-time curve from time zero extrapolated to infinite time.

Outcome measures

Measure	Normal Renal Function n=11 Participants Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Mild Renal Impairment n=4 Participants Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Moderate Renal Impairment n=5 Participants Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Severe Renal Impairment n=6 Participants Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	End Stage Renal Disease n=10 Participants Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \< 15 mL/ min per 1.73 m\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
Apparent Volume of Distribution (Vd/F) of Daclatasvir	105.157 Liters Geometric Coefficient of Variation 37	63.761 Liters Geometric Coefficient of Variation 30	59.054 Liters Geometric Coefficient of Variation 36	79.769 Liters Geometric Coefficient of Variation 35	95.186 Liters Geometric Coefficient of Variation 37

SECONDARY outcome

Timeframe: First dose up to Day 5 post last dose for AEs; up to 30 days post last dose for SAEs

Population: Analysis was done in safety data set population, defined as all the participants who received the study medication.

Adverse event (AE) was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing 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 hospitalisation.

Outcome measures

Measure	Normal Renal Function n=12 Participants Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Mild Renal Impairment n=6 Participants Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Moderate Renal Impairment n=6 Participants Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Severe Renal Impairment n=12 Participants Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	End Stage Renal Disease Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \< 15 mL/ min per 1.73 m\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events and Who Died SAEs	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events and Who Died Death	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events and Who Died Discontinuations due to AEs	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Baseline up to Day 5 post dose

Population: The analysis was done in safety population.

Significant laboratory abnormalities were defined as any test results which were observed beyond the clinically acceptable limits as per the discretion of investigator.

Outcome measures

Measure	Normal Renal Function n=12 Participants Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Mild Renal Impairment n=6 Participants Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Moderate Renal Impairment n=6 Participants Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Severe Renal Impairment n=12 Participants Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	End Stage Renal Disease Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \< 15 mL/ min per 1.73 m\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
Number of Participants With Clinically Significant Laboratory Marked Abnormalities Reported as Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Baseline up to Day 5 post dose

Population: Analysis was done in safety data set population.

The number of participants with clinically relevant changes in ECG which were considered as adverse events was determined.

Outcome measures

Measure	Normal Renal Function n=12 Participants Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Mild Renal Impairment n=6 Participants Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Moderate Renal Impairment n=6 Participants Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Severe Renal Impairment n=12 Participants Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	End Stage Renal Disease Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \< 15 mL/ min per 1.73 m\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Reported as Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Baseline up to Day 5 post dose

Population: Analysis was done in safety data set population.

The total number of participants with abnormal range vital signs which were considered as adverse events was determined.

Outcome measures

Measure	Normal Renal Function n=12 Participants Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \>= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Mild Renal Impairment n=6 Participants Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Moderate Renal Impairment n=6 Participants Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	Severe Renal Impairment n=12 Participants Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.	End Stage Renal Disease Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) \< 15 mL/ min per 1.73 m\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
Number of Participants With Out-of-range Vital Signs Reported as Adverse Events	0 Participants	0 Participants	0 Participants	1 Participants	—

Adverse Events

Group-A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mild/Moderate Renal Impairment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Mild/Severe Renal Impairment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

End Stage Renal Disease

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Group-A n=12 participants at risk Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method \>=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m\^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.	Mild/Moderate Renal Impairment n=6 participants at risk Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m\^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.	Mild/Severe Renal Impairment n=6 participants at risk Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m\^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m\^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.	End Stage Renal Disease n=12 participants at risk Participants with end stage renal disease and had eGFR \<15 mL/ min per 1.73 m\^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/12 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs	0.00% 0/6 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs	16.7% 1/6 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs	0.00% 0/12 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs
Nervous system disorders Dizziness	0.00% 0/12 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs	0.00% 0/6 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs	0.00% 0/6 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs	8.3% 1/12 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/12 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs	16.7% 1/6 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs	0.00% 0/6 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs	0.00% 0/12 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs
Cardiac disorders Palpitations	0.00% 0/12 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs	0.00% 0/6 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs	0.00% 0/6 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs	8.3% 1/12 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs
Gastrointestinal disorders Nausea	0.00% 0/12 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs	0.00% 0/6 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs	0.00% 0/6 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs	8.3% 1/12 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs
Vascular disorders Hypotension	0.00% 0/12 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs	0.00% 0/6 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs	0.00% 0/6 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs	8.3% 1/12 • First dose up to Day 5 post last dose of study treatment for AEs; up to 30 days post last dose for SAEs

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER