Single-Dose Pharmacokinetics of BMS-790052 in Participants With Hepatic Impairment

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00859053
• Collaborator: (none)
• Enrollment: 46
• Locations: 2
• Arms: 4
• Duration (Months): 6
• Patients Per Site: 23
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the effects of hepatic impairment on the single dose pharmacokinetics of BMS-790052.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Insufficiency	Drug: BMS-790052	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: Single-Dose Pharmacokinetics of BMS-790052 in Subjects With Hepatic Impairment Compared to Healthy Subjects
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: BMS-790052 in Child-Pugh A	Drug: BMS-790052; Capsules, Oral, 30 mg, single dose, one day
Active Comparator: BMS-790052 in Child-Pugh B	Drug: BMS-790052; Capsules, Oral, 30 mg, single dose, one day
Active Comparator: BMS-790052 in Child-Pugh C	Drug: BMS-790052; Capsules, Oral, 30 mg, single dose, one day
Active Comparator: BMS-790052 in Healthy Subjects	Drug: BMS-790052; Capsules, Oral, 30 mg, single dose, one day

Outcome Measures

Primary Outcome Measures

1. Maximum Observed Plasma Concentration (Cmax) of BMS-790052 [Pre-dose (0), 0.5,1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)]

   Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. The plasma samples were analysed for BMS-790052 by using a validated liquid chromatography tandem mass spectrometric (LC-MS/MS) assay.

2. Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Last Measurable Concentration [AUC(0-T)] of BMS-790052 [Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)]

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

3. Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-790052 [Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)]

   AUC(INF) was estimated as AUC(0-T) + Ct/λ z, where λ z was the terminal elimination rate constant and Ct was the last observable concentration.

4. Time to Reach Maximum Observed Plasma Concentration (Tmax) of BMS-790052 [Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)]

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

5. Terminal Half-life (T-HALF) of BMS-790052 [Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)]

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

6. Apparent Total Body Clearance (CLT/F) of BMS-790052 [Pre-dose (0), 0.5,1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)]

   Apparent total body clearance was calculated as dose/AUC(INF). AUC(INF) was estimated as AUC(0-T) + Ct/λ z, where λ z was the terminal elimination rate constant and Ct was the last observable concentration.

7. Apparent Clearance of Free BMS-790052 (CLu/F) [Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)]

   CLu/F was calculated by dividing the apparent total body clearance (CLT/F) by mean fraction of unbound drug (fu) for both (1 hour and 4 hour post dose) time points combined. Apparent total body clearance was calculated as dose/AUC(INF). AUC(INF) was estimated as AUC(0-T) + Ct/ λz, where λz was the terminal elimination rate constant and Ct was the last observable concentration.

8. The Apparent Volume of Distribution at Steady State (Vss/F) [Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)]

   Apparent volume of distribution was calculated by dividing the product of the dose and mean residence time (MRT) by AUC(INF). AUC(INF) was estimated as AUC(0-T) + Ct/λ z, where λ z was the terminal elimination rate constant and Ct was the last observable concentration.

Secondary Outcome Measures

1. Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died [Day 1 to end of study for AEs and, Day 1 to up to 30 days after last dose for SAE.]

   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 hospitalization. Study Discharge (end of study) was Day 4 (healthy participants) or Day 5 (hepatically impaired participants).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Key Inclusion Criteria:

• Male and female subjects aged 18 to 70 years, with hepatic impairment conforming to Child-Pugh class A, B or C

• Healthy subjects to the extent possible matched to the first four hepatically impaired subject in each Child-Pugh class with regard to age (approximately ± 10 years), body weight (approximately ± 20%) and gender

Key Exclusion Criteria:

• History of esophageal and gastric variceal bleeding within past 6 months

• Primarily cholestatic liver diseases

• Active alcoholic hepatitis

• Stable encephalopathy of >= Stage 2

• Presence of severe ascites or edema

• Presence of hepatopulmonary or hepatorenal syndrome

• Positive for HCV, unless HCV RNA is undetectable

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advanced Clinical Research Institute	Anaheim	California	United States	92801
2	Orlando Clinical Research Center	Orlando	Florida	United States	32809

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT00859053
• Other Study ID Numbers: AI444-013
• First Posted: Mar 10, 2009
• Last Update Posted: Oct 8, 2015
• Last Verified: Sep 1, 2015

• Additional relevant MeSH terms: Hepatic Insufficiency; Liver Failure

Study Results

Participant Flow

Pre-assignment Detail	A total of 46 participants were enrolled in the study, of which 30 participants were treated with study drug and 16 participants were not treated with study drug as they no longer met study criteria.

Arm/Group Title	Child Pugh Class-A	Child Pugh Class-B	Child Pugh Class-C	Healthy Participants
Arm/Group Description	Participants with mild liver damage were administered with single oral dose of 30 milligrams (mg) (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
Period Title: Overall Study
STARTED	6	6	6	12
COMPLETED	6	6	6	12
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Child Pugh Class-A	Child Pugh Class-B	Child Pugh Class-C	Healthy Participants	Total
Arm/Group Description	Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Total of all reporting groups
Overall Participants	6	6	6	12	30
Age, Customized (participants) [Number]
< 65 years	6 100%	5 83.3%	5 83.3%	12 100%	28 93.3%
>= 65 years	0 0%	1 16.7%	1 16.7%	0 0%	2 6.7%
Sex: Female, Male (Count of Participants)
Female	2 33.3%	3 50%	2 33.3%	5 41.7%	12 40%
Male	4 66.7%	3 50%	4 66.7%	7 58.3%	18 60%

Outcome Measures

1. Primary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) of BMS-790052
Description	Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. The plasma samples were analysed for BMS-790052 by using a validated liquid chromatography tandem mass spectrometric (LC-MS/MS) assay.
Time Frame	Pre-dose (0), 0.5,1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)

Outcome Measure Data

Analysis Population Description

Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).

Arm/Group Title	Child Pugh Class-A	Child Pugh Class-B	Child Pugh Class-C	Healthy Participants
Arm/Group Description	Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
Measure Participants	6	6	6	12
Geometric Mean (Geometric Coefficient of Variation) [nanograms/milliliter (ng/mL)]	380 (44)	382 (23)	317 (65)	698 (30)

2. Primary Outcome

Title	Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Last Measurable Concentration [AUC(0-T)] of BMS-790052
Description	AUC(0-T) was calculated by the sum of linear trapezoids using non-compartmental analysis.
Time Frame	Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)

Outcome Measure Data

Analysis Population Description

Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).

Arm/Group Title	Child Pugh Class-A	Child Pugh Class-B	Child Pugh Class-C	Healthy Participants
Arm/Group Description	Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
Measure Participants	6	6	6	12
Geometric Mean (Geometric Coefficient of Variation) [ng*hour (h)/mL]	4151 (43)	4490 (38)	4534 (74)	7165 (24)

3. Primary Outcome

Title	Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-790052
Description	AUC(INF) was estimated as AUC(0-T) + Ct/λ z, where λ z was the terminal elimination rate constant and Ct was the last observable concentration.
Time Frame	Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)

Outcome Measure Data

Analysis Population Description

Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).

Arm/Group Title	Child Pugh Class-A	Child Pugh Class-B	Child Pugh Class-C	Healthy Participants
Arm/Group Description	Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
Measure Participants	6	6	6	12
Geometric Mean (Geometric Coefficient of Variation) [ng* h/mL]	4174 (43)	4550 (39)	4649 (78)	7286 (25)

4. Primary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax) of BMS-790052
Description	Tmax was defined as the time required to reach maximum observed plasma concentration. Tmax was directly determined from the raw plasma concentration-time data.
Time Frame	Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)

Outcome Measure Data

Analysis Population Description

Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).

Arm/Group Title	Child Pugh Class-A	Child Pugh Class-B	Child Pugh Class-C	Healthy Participants
Arm/Group Description	Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
Measure Participants	6	6	6	12
Median (Full Range) [hours]	1.5	1.0	1.5	1.3

5. Primary Outcome

Title	Terminal Half-life (T-HALF) of BMS-790052
Description	Terminal half-life was the time required for one half of the total amount of administered drug eliminated from the body.
Time Frame	Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)

Outcome Measure Data

Analysis Population Description

Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).

Arm/Group Title	Child Pugh Class-A	Child Pugh Class-B	Child Pugh Class-C	Healthy Participants
Arm/Group Description	Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
Measure Participants	6	6	6	12
Mean (Standard Deviation) [hours]	12.3 (2.49)	15.0 (4.59)	17.2 (10.55)	12.4 (2.23)

6. Primary Outcome

Title	Apparent Total Body Clearance (CLT/F) of BMS-790052
Description	Apparent total body clearance was calculated as dose/AUC(INF). AUC(INF) was estimated as AUC(0-T) + Ct/λ z, where λ z was the terminal elimination rate constant and Ct was the last observable concentration.
Time Frame	Pre-dose (0), 0.5,1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)

Outcome Measure Data

Analysis Population Description

Analysis was performed in PK set population.

Arm/Group Title	Child Pugh Class-A	Child Pugh Class-B	Child Pugh Class-C	Healthy Participants
Arm/Group Description	Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
Measure Participants	6	6	6	12
Geometric Mean (Geometric Coefficient of Variation) [milliliter/minute (mL/min)]	120 (85)	110 (47)	108 (78)	69 (29)

7. Primary Outcome

Title	Apparent Clearance of Free BMS-790052 (CLu/F)
Description	CLu/F was calculated by dividing the apparent total body clearance (CLT/F) by mean fraction of unbound drug (fu) for both (1 hour and 4 hour post dose) time points combined. Apparent total body clearance was calculated as dose/AUC(INF). AUC(INF) was estimated as AUC(0-T) + Ct/ λz, where λz was the terminal elimination rate constant and Ct was the last observable concentration.
Time Frame	Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)

Outcome Measure Data

Analysis Population Description

Analysis was performed in PK population.

Arm/Group Title	Child Pugh Class-A	Child Pugh Class-B	Child Pugh Class-C	Healthy Participants
Arm/Group Description	Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
Measure Participants	6	6	6	12
Geometric Mean (Geometric Coefficient of Variation) [mL/min]	19529 (66)	12028 (52)	12468 (61)	11796 (33)

8. Primary Outcome

Title	The Apparent Volume of Distribution at Steady State (Vss/F)
Description	Apparent volume of distribution was calculated by dividing the product of the dose and mean residence time (MRT) by AUC(INF). AUC(INF) was estimated as AUC(0-T) + Ct/λ z, where λ z was the terminal elimination rate constant and Ct was the last observable concentration.
Time Frame	Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)

Outcome Measure Data

Analysis Population Description

Analysis was performed in PK population.

Arm/Group Title	Child Pugh Class-A	Child Pugh Class-B	Child Pugh Class-C	Healthy Participants
Arm/Group Description	Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
Measure Participants	6	6	6	12
Geometric Mean (Geometric Coefficient of Variation) [mL]	98557 (67)	111612 (24)	123034 (56)	61250 (19)

9. Secondary Outcome

Title	Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died
Description	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 hospitalization. Study Discharge (end of study) was Day 4 (healthy participants) or Day 5 (hepatically impaired participants).
Time Frame	Day 1 to end of study for AEs and, Day 1 to up to 30 days after last dose for SAE.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Child Pugh Class-A	Child Pugh Class-B	Child Pugh Class-C	Healthy Participants
Arm/Group Description	Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.	Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
Measure Participants	6	6	6	12
SAEs	0 0%	0 0%	0 0%	0 0%
Death	0 0%	0 0%	0 0%	0 0%
Discontinuations due to AEs	0 0%	0 0%	0 0%	0 0%

Adverse Events

Arm/Group Title	Child Pugh Class-A		Child Pugh Class-B		Child Pugh Class-C		Healthy Participants
Arm/Group Description	Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.		Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.		Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.		Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
All Cause Mortality
	Child Pugh Class-A		Child Pugh Class-B		Child Pugh Class-C		Healthy Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Child Pugh Class-A		Child Pugh Class-B		Child Pugh Class-C		Healthy Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Child Pugh Class-A		Child Pugh Class-B		Child Pugh Class-C		Healthy Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/6 (16.7%)		3/6 (50%)		2/6 (33.3%)		2/12 (16.7%)
Gastrointestinal disorders
Nausea	0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/12 (0%)
Vomiting	0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/12 (0%)
Diarrhoea	0/6 (0%)		0/6 (0%)		0/6 (0%)		1/12 (8.3%)
General disorders
Malaise	1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/12 (0%)
Infections and infestations
Urinary tract infection	0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/12 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/12 (0%)
Limb discomfort	0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/12 (0%)
Nervous system disorders
Dizziness	0/6 (0%)		1/6 (16.7%)		0/6 (0%)		1/12 (8.3%)
Headache	1/6 (16.7%)		0/6 (0%)		1/6 (16.7%)		0/12 (0%)
Renal and urinary disorders
Dysuria	0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/12 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/12 (0%)
Rhinorrhoea	1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/12 (0%)
Oropharyngeal pain	1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/12 (0%)
Skin and subcutaneous tissue disorders
Cold sweat	0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.