Trial Outcomes & Findings for Pharmacodynamics, Safety and Pharmacokinetics of BMS-663068, an HIV Attachment Inhibitor, in HIV-1 (NCT NCT01009814)

Results Overview

The primary assessment of the antiviral activity of BMS-663068 was assessed on the log10 change from Baseline in HIV RNA to Day 9. Baseline was the last non-missing observation before first dose (Day 1 pre-dose) and change from Baseline was calculated by subtracting Baseline value from post-Baseline visit value. An analysis of covariance (ANCOVA) model correcting for Baseline HIV viral load and treatment group was used to test the differences in mean log10 decrease in HIV RNA at Day 9 between 2 regimen groups by antiretroviral treatment history (ARV \[antiretroviral\] naive, ARV experienced, and combined \[ARV naive + ARV experienced\]). For the combined group (ARV naive +ARV experienced) an additional ANCOVA was used correcting also for treatment history as an additional covariate. Only Clade B participants were included in the population.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

Baseline and Day 9

Results posted on

2020-01-03

Participant Flow

This was a randomized, open label, multiple-dose study to evaluate the pharmacodynamics, safety and pharmacokinetics of BMS-663068 in human immunodeficiency virus 1 (HIV-1) infected participants. The study was conducted at single center in Germany.

A total of 75 participants were screened, of which 25 were screen failure, and 50 eligible participants were enrolled into the study and were randomized.

Participant milestones

Participant milestones
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Overall Study STARTED	10	10	10	10	10
Overall Study COMPLETED	9	9	10	10	10
Overall Study NOT COMPLETED	1	1	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Overall Study No longer met study criteria	1	1	0	0	0

Baseline Characteristics

Pharmacodynamics, Safety and Pharmacokinetics of BMS-663068, an HIV Attachment Inhibitor, in HIV-1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM n=10 Participants All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.	Total n=50 Participants Total of all reporting groups
Age, Continuous	41.3 Years STANDARD_DEVIATION 8.29 • n=5 Participants	40.7 Years STANDARD_DEVIATION 13.70 • n=7 Participants	40.7 Years STANDARD_DEVIATION 6.53 • n=5 Participants	38.4 Years STANDARD_DEVIATION 7.83 • n=4 Participants	42.7 Years STANDARD_DEVIATION 8.42 • n=21 Participants	40.8 Years STANDARD_DEVIATION 9.01 • n=10 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	10 Participants n=21 Participants	47 Participants n=10 Participants
Race/Ethnicity, Customized Race · White	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	10 Participants n=21 Participants	50 Participants n=10 Participants

PRIMARY outcome

Timeframe: Baseline and Day 9

Population: Pharmacodynamic Population. It comprised of all participants for whom pharmacodynamic measurements were available at Baseline and at least one other time.

The primary assessment of the antiviral activity of BMS-663068 was assessed on the log10 change from Baseline in HIV RNA to Day 9. Baseline was the last non-missing observation before first dose (Day 1 pre-dose) and change from Baseline was calculated by subtracting Baseline value from post-Baseline visit value. An analysis of covariance (ANCOVA) model correcting for Baseline HIV viral load and treatment group was used to test the differences in mean log10 decrease in HIV RNA at Day 9 between 2 regimen groups by antiretroviral treatment history (ARV \[antiretroviral\] naive, ARV experienced, and combined \[ARV naive + ARV experienced\]). For the combined group (ARV naive +ARV experienced) an additional ANCOVA was used correcting also for treatment history as an additional covariate. Only Clade B participants were included in the population.

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=9 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS n=9 Participants All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM n=10 Participants All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Mean Logarithm With Base 10 (Log10) Change From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) at Day 9	-1.3445 Log10 copies per milliliter (c/mL) Standard Error 0.07925	-1.2532 Log10 copies per milliliter (c/mL) Standard Error 0.10610	-1.2381 Log10 copies per milliliter (c/mL) Standard Error 0.10455	-1.1888 Log10 copies per milliliter (c/mL) Standard Error 0.12938	-0.8760 Log10 copies per milliliter (c/mL) Standard Error 0.22621

SECONDARY outcome

Timeframe: Baseline (Day 1 pre-dose), Day 8, Day 15 and Day 50

Population: Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected for evaluation of CD4+ and CD8+ cells at Baseline (Day 1, pre-dose), Day 8, Day 15 (Follow up) and Day 50 (study discharge). Baseline was the last non-missing observation before first dose (Day 1 pre-dose) and change from Baseline was calculated by subtracting Baseline value from post-Baseline visit value.

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=9 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS n=9 Participants All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM n=10 Participants All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count and Cluster of Differentiation 8 Positive (CD8+) Cell Count CD4+, Day 8, n=9, 9, 10, 10, 10	114.2 Cells per microliter (cells/μL) Standard Error 74.55	93.4 Cells per microliter (cells/μL) Standard Error 25.12	109.8 Cells per microliter (cells/μL) Standard Error 32.37	38.5 Cells per microliter (cells/μL) Standard Error 41.61	32.0 Cells per microliter (cells/μL) Standard Error 36.23
Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count and Cluster of Differentiation 8 Positive (CD8+) Cell Count CD4+, Day 15, n=9, 9, 10, 10, 10	58.4 Cells per microliter (cells/μL) Standard Error 92.14	-6.1 Cells per microliter (cells/μL) Standard Error 28.15	117.6 Cells per microliter (cells/μL) Standard Error 27.67	44.6 Cells per microliter (cells/μL) Standard Error 69.94	10.4 Cells per microliter (cells/μL) Standard Error 23.38
Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count and Cluster of Differentiation 8 Positive (CD8+) Cell Count CD4+, Day 50, n=9, 9, 10, 10, 9	22.0 Cells per microliter (cells/μL) Standard Error 91.55	-50.3 Cells per microliter (cells/μL) Standard Error 18.06	71.1 Cells per microliter (cells/μL) Standard Error 28.55	-48.4 Cells per microliter (cells/μL) Standard Error 61.21	-19.2 Cells per microliter (cells/μL) Standard Error 17.05
Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count and Cluster of Differentiation 8 Positive (CD8+) Cell Count CD8+, Day 8, n=9, 9, 10, 10, 10	384.2 Cells per microliter (cells/μL) Standard Error 164.35	189.0 Cells per microliter (cells/μL) Standard Error 134.27	218.4 Cells per microliter (cells/μL) Standard Error 125.65	114.9 Cells per microliter (cells/μL) Standard Error 131.64	94.6 Cells per microliter (cells/μL) Standard Error 152.73
Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count and Cluster of Differentiation 8 Positive (CD8+) Cell Count CD8+, Day 15, n=9, 9, 10, 10, 10	64.8 Cells per microliter (cells/μL) Standard Error 230.86	-153.2 Cells per microliter (cells/μL) Standard Error 137.18	85.6 Cells per microliter (cells/μL) Standard Error 112.65	-99.6 Cells per microliter (cells/μL) Standard Error 159.83	-4.4 Cells per microliter (cells/μL) Standard Error 126.77
Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count and Cluster of Differentiation 8 Positive (CD8+) Cell Count CD8+, Day 50, n=9, 9, 10, 10, 9	-37.6 Cells per microliter (cells/μL) Standard Error 161.11	-292.4 Cells per microliter (cells/μL) Standard Error 121.73	139.7 Cells per microliter (cells/μL) Standard Error 95.00	6.0 Cells per microliter (cells/μL) Standard Error 170.29	-48.2 Cells per microliter (cells/μL) Standard Error 140.55

SECONDARY outcome

Timeframe: Baseline (Day 1 pre-dose), Day 8, Day 15 and Day 50

Population: Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected for evaluation of percent CD4+ and percent CD8+ cells at Baseline (Day 1, pre-dose), Day 8, Day 15 (Follow up) and Day 50 (study discharge). Baseline was the last non-missing observation before first dose (Day 1 pre-dose) and change from Baseline was calculated by subtracting Baseline visit value from post-Baseline visit value.

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=9 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS n=9 Participants All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM n=10 Participants All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count Percent CD8+, Day 8, n=9, 9, 10, 10, 10	1.0 Percent cells per microliter Standard Error 0.76	-0.4 Percent cells per microliter Standard Error 1.02	0.1 Percent cells per microliter Standard Error 1.06	-0.3 Percent cells per microliter Standard Error 1.11	-0.2 Percent cells per microliter Standard Error 1.20
Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count Percent CD8+, Day 15, n=9, 9, 10, 10, 10	-3.4 Percent cells per microliter Standard Error 0.73	-2.8 Percent cells per microliter Standard Error 1.00	-2.9 Percent cells per microliter Standard Error 1.49	-4.0 Percent cells per microliter Standard Error 1.73	-2.9 Percent cells per microliter Standard Error 1.16
Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count Percent CD8+, Day 50, n=9, 9, 10, 10, 9	-2.2 Percent cells per microliter Standard Error 1.01	-0.7 Percent cells per microliter Standard Error 1.22	-0.9 Percent cells per microliter Standard Error 1.19	1.6 Percent cells per microliter Standard Error 1.52	-2.4 Percent cells per microliter Standard Error 1.57
Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count Percent CD4+, Day 8, n=9, 9, 10, 10, 10	-1.0 Percent cells per microliter Standard Error 1.12	1.2 Percent cells per microliter Standard Error 0.97	0.6 Percent cells per microliter Standard Error 0.78	0.1 Percent cells per microliter Standard Error 0.72	1.4 Percent cells per microliter Standard Error 1.11
Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count Percent CD4+, Day 15, n=9, 9, 10, 10, 10	1.6 Percent cells per microliter Standard Error 1.00	1.2 Percent cells per microliter Standard Error 0.64	1.4 Percent cells per microliter Standard Error 1.33	2.4 Percent cells per microliter Standard Error 1.11	0.9 Percent cells per microliter Standard Error 1.51
Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count Percent CD4+, Day 50, n=9, 9, 10, 10, 9	1.4 Percent cells per microliter Standard Error 0.84	1.1 Percent cells per microliter Standard Error 1.15	0.3 Percent cells per microliter Standard Error 0.90	-1.7 Percent cells per microliter Standard Error 0.97	0.6 Percent cells per microliter Standard Error 1.45

SECONDARY outcome

Timeframe: Up to 50 days

Population: Safety Population

An AE is any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. Any untoward medical occurrence resulting in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent serious outcomes were categorized as SAE. Treatment emergent adverse events (occurred after start of treatment) have been presented.Safety Population comprised of all randomized participants who used the trial medication at least once.

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM n=10 Participants All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Number of Participants With Treatment Emergent Non-serious Adverse Event (Non-SAE) and Serious AE (SAE) Non-SAE	8 Participants	5 Participants	9 Participants	8 Participants	9 Participants
Number of Participants With Treatment Emergent Non-serious Adverse Event (Non-SAE) and Serious AE (SAE) SAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 50 days

Population: Safety Population

A complete physical examination included, at a minimum, assessment of the Cardiovascular, Respiratory, Gastrointestinal and Neurological systems. A brief physical examination included, at a minimum assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). Any abnormality found by investigator during physical examination were recorded. Number of participants with any abnormality in physical examination during study have been reported.

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM n=10 Participants All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Number of Participants With Any Abnormality in Physical Examination	1 Participants	0 Participants	2 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 50 days

Population: Safety Population

Vital signs including DBP and SBP were recorded. Normal ranges were as following: For DBP, lower limit: value \<55 millimeter of mercury (mmHg) and change \<-20 mmHg; upper limit: value \>90 mmHg and change \>20 mmHg). For SBP, lower limit: value \<90 mmHg and change \<-10 mmHg; upper limit: value \>140 mmHg and change \>10 mmHg. Number of participants with worst-case abnormalities are presented. Worst-case abnormality was defined as: (1) Below Normal: at least one post-Baseline assessment was below normal range, and no post-Baseline assessment was above normal range. (2) Above Normal: at least one post-Baseline assessment was above normal range, and no post-Baseline assessment was below normal range. (3) Within Normal: all post-Baseline assessments were within normal range. It was to be considered as 'Missing' when there were no post-Baseline assessments.

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM n=10 Participants All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) DBP, Below Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) DBP, Within Normal	10 Participants	10 Participants	10 Participants	10 Participants	10 Participants
Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) SBP, Above Normal	0 Participants	3 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) SBP, Below Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) SBP, Within Normal	10 Participants	7 Participants	9 Participants	10 Participants	9 Participants
Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) DBP, Above Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 50 days

Population: Safety Population

Vital signs (body temperature, RR, and HR) were recorded. Normal range were: For HR, lower limit: 55 beats per minute (bpm) and change \<-15 bpm; upper limit: \>100 bpm and change \>30 bpm). For temperature, lower limit: 36.0 Celsius; upper limit: \>37.5 Celsius or change \>1.7 Celsius). For RR, lower limit: 8 breaths per minute; upper limit: \>16 breaths per minute or change \>10 breaths per minute. Number of participants with worst-case abnormalities are presented. Worst-case abnormality was defined as: (1) Below Normal: at least one post-Baseline assessment was below normal range, and no post-Baseline assessment was above normal range. (2) Above Normal: at least one post-Baseline assessment was above normal range, and no post-Baseline assessment was below normal range. (3) Within Normal: all post-Baseline assessments were within normal range. It was to be considered as 'Missing' when there were no post-Baseline assessments.

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM n=10 Participants All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] Temperature, Below Normal	1 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] HR, Above Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] HR, Below Normal	1 Participants	2 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] HR, Within Normal	9 Participants	8 Participants	9 Participants	10 Participants	9 Participants
Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] RR, Above Normal	4 Participants	3 Participants	3 Participants	3 Participants	8 Participants
Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] RR, Below Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] RR, Within Normal	6 Participants	7 Participants	7 Participants	7 Participants	2 Participants
Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] Temperature, Above Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] Temperature, Within Normal	9 Participants	8 Participants	10 Participants	9 Participants	10 Participants

SECONDARY outcome

Timeframe: Up to 50 days

Population: Safety Population

A 12-lead ECG was recorded during the study using an ECG machine that automatically measures ECG parameters. Normal range for ECG parameters were: PR interval (upper: 200 milliseconds \[ms\]); QRS (lower: 50 ms; upper: 120 ms); Corrected QT interval by Bazett formula (QTcB) (change from Baseline - increases by \> 30 ms); Corrected QT interval by Fredericia formula (QTcF) (change from Baseline - increases by \> 30 ms). Number of participants with worst-case abnormalities are presented which was defined as: (1) Below Normal: at least one post-Baseline assessment was below normal range, and no post-Baseline assessment was above normal range. (2) Above Normal: at least one post-Baseline assessment was above normal range, and no post-Baseline assessment was below normal range. Within Normal: all post-Baseline assessments were within normal range. It was to be considered as 'Missing' when there were no post-Baseline assessments.

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM n=10 Participants All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters PR interval, Above Normal	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters PR interval, Below Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters PR interval, Within Normal	10 Participants	9 Participants	10 Participants	10 Participants	9 Participants
Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters QTcB, Above Normal	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters QTcB, Below Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters QTcB, Within Normal	10 Participants	9 Participants	8 Participants	10 Participants	9 Participants
Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters QTcF, Above Normal	1 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters QTcF, Below Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters QTcF, Within Normal	9 Participants	10 Participants	9 Participants	10 Participants	8 Participants

SECONDARY outcome

Timeframe: Up to 50 days

Population: Safety Population

Laboratory parameters included hematology, clinical chemistry and urine parameters. Clinically significant abnormal laboratory findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Any abnormal laboratory test results which were considered clinically significant by the investigator were recorded on the case report form. Number of participants with any clinically significant abnormalities in laboratory parameters have been presented.

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM n=10 Participants All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours

Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points to assess Cmax of BMS-626529 following Q12H dosing. Geometric mean and geometric coefficient of variation are presented for Day 1, Day 8 morning dose (Anti Meridiem \[AM\]), Day 8 evening dose (Post Meridiem \[PM\]) and Day 8 morning + evening dose (AM+PM). Pharmacokinetic parameter values were derived by non-compartmental methods. Pharmacokinetic (PK) Population was used which comprised of all participants who receive BMS-663068 and provided pharmacokinetic samples.

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM n=10 Participants All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Maximum Observed Plasma Concentration (Cmax) of BMS-626529 Following Q12H Dosing Day 1, n=10,10,10,10	1.74 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 59.9	3.52 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 26.6	4.05 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 35.8	2.55 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 27.4	—
Maximum Observed Plasma Concentration (Cmax) of BMS-626529 Following Q12H Dosing Day 8, AM, n=9,10,10,10	2.22 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 67.1	5.55 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 37.5	5.10 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 57.4	3.18 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 22.0	—
Maximum Observed Plasma Concentration (Cmax) of BMS-626529 Following Q12H Dosing Day 8, PM, n=9,10,10,10	2.25 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 46.4	4.60 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 29.2	4.77 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 36.2	3.61 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 27.5	—
Maximum Observed Plasma Concentration (Cmax) of BMS-626529 Following Q12H Dosing Day 8, AM+PM, n=9,10,10,10	2.24 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 43.3	5.05 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 31.7	4.93 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 40.1	3.39 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 15.9	—

SECONDARY outcome

Timeframe: Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours

Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points to assess Cmax of BMS-626529 following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Day 8 evening dose (PM) and Day 8 morning (AM) + evening dose (PM).

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Cmax of BMS-626529 Following QHS Dosing Day 1, n=10	3.85 μg/mL Geometric Coefficient of Variation 32.0	—	—	—	—
Cmax of BMS-626529 Following QHS Dosing Day 8, PM, n=9	3.47 μg/mL Geometric Coefficient of Variation 31.7	—	—	—	—
Cmax of BMS-626529 Following QHS Dosing Day 8, AM+PM, n=9	3.47 μg/mL Geometric Coefficient of Variation 31.7	—	—	—	—

SECONDARY outcome

Timeframe: Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours; Days 5,6,7: pre-morning dose

Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points to access Ctrough of BMS-626529 following Q12H dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Days 5, 6, 7, 8, Day 8 morning dose (AM) and Day 8 evening dose (PM).

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM n=10 Participants All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing Day 6, n=9,10,10,10	0.436 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 89.5	0.839 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 49.1	0.737 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 73.2	0.451 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 49.2	—
Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing Day 1, n=10,10,10,10	0.349 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 156	0.499 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 83.4	0.640 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 114	0.244 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 78.3	—
Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing Day 5, n=9,10,10,10	0.473 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 119	1.04 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 72.2	0.760 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 67.1	0.518 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 48.2	—
Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing Day 7, n=9,10,10,10	0.495 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 96.5	1.08 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 72.9	0.998 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 91.8	0.542 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 73.5	—
Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing Day 8, n=9,10,10,10	0.460 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 89.2	0.743 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 47.1	0.720 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 83.5	0.628 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 76.9	—
Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing Day 8, AM, n=9,10,10,10	0.422 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 69.1	0.951 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 88.2	0.579 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 71.5	0.469 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 122	—
Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing Day 8, PM, n=9,10,10,10	0.358 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 102	0.653 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 109	0.553 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 68.1	0.487 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 47.5	—

SECONDARY outcome

Timeframe: Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours; Days 5,6,7: pre-evening dose

Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points to assess Ctrough of BMS-626529 following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Days 5, 6, 7, 8 and Day 8 evening dose (PM).

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Ctrough of BMS-626529 Following QHS Dosing Day 1, n=10	0.699 μg/mL Geometric Coefficient of Variation 93.4	—	—	—	—
Ctrough of BMS-626529 Following QHS Dosing Day 5, n=9	0.0705 μg/mL Geometric Coefficient of Variation 114	—	—	—	—
Ctrough of BMS-626529 Following QHS Dosing Day 6, n=9	0.0743 μg/mL Geometric Coefficient of Variation 97.7	—	—	—	—
Ctrough of BMS-626529 Following QHS Dosing Day 7, n=9	0.0719 μg/mL Geometric Coefficient of Variation 166	—	—	—	—
Ctrough of BMS-626529 Following QHS Dosing Day 8, n=9	0.0546 μg/mL Geometric Coefficient of Variation 146	—	—	—	—
Ctrough of BMS-626529 Following QHS Dosing Day 8, PM, n=9	0.0544 μg/mL Geometric Coefficient of Variation 156	—	—	—	—

SECONDARY outcome

Timeframe: Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours

Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points to assess AUC (tau) of BMS-626529 following Q12H dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Day 8 morning dose (AM) and Day 8 evening dose (PM).

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM n=10 Participants All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Area Under the Concentration-time Curve in One Dosing Interval (AUC [Tau]) of BMS-626529 Following Q12H Dosing Day 1, n=10,10,10,10	9.16 Hour*micrograms per milliliter Geometric Coefficient of Variation 68.7	18.3 Hour*micrograms per milliliter Geometric Coefficient of Variation 28.8	20.6 Hour*micrograms per milliliter Geometric Coefficient of Variation 45.0	13.8 Hour*micrograms per milliliter Geometric Coefficient of Variation 28.3	—
Area Under the Concentration-time Curve in One Dosing Interval (AUC [Tau]) of BMS-626529 Following Q12H Dosing Day 8, AM, n=9,10,10,10	13.1 Hour*micrograms per milliliter Geometric Coefficient of Variation 62.7	29.9 Hour*micrograms per milliliter Geometric Coefficient of Variation 37.0	27.6 Hour*micrograms per milliliter Geometric Coefficient of Variation 48.4	19.5 Hour*micrograms per milliliter Geometric Coefficient of Variation 20.5	—
Area Under the Concentration-time Curve in One Dosing Interval (AUC [Tau]) of BMS-626529 Following Q12H Dosing Day 8, PM, n=9,10,10,10	13.1 Hour*micrograms per milliliter Geometric Coefficient of Variation 63.8	30.6 Hour*micrograms per milliliter Geometric Coefficient of Variation 26.3	27.0 Hour*micrograms per milliliter Geometric Coefficient of Variation 45.2	22.5 Hour*micrograms per milliliter Geometric Coefficient of Variation 34.0	—

SECONDARY outcome

Timeframe: Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours

Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points to assess AUC (tau) of BMS-626529 following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1 and Day 8 evening dose (PM).

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
AUC (Tau) of BMS-626529 Following QHS Dosing Day 1, n=10	25.5 Hour*micrograms per milliliter Geometric Coefficient of Variation 38.0	—	—	—	—
AUC (Tau) of BMS-626529 Following QHS Dosing Day 8 PM, n=9	23.0 Hour*micrograms per milliliter Geometric Coefficient of Variation 48.2	—	—	—	—

SECONDARY outcome

Timeframe: Day 8: pre-morning dose, 1,2,3,4,5,6,8,12, 13,14,15,16,17,18,20 hours

Population: PK Population

Blood samples were collected at indicated time points to assess AUC (0-24) of BMS-626529 following Q12H dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8.

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM n=10 Participants All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Area Under the Concentration-time Curve Over a 24-hour Period (AUC [0-24]) of BMS-626529 Following Q12H Dosing	26.8 Hour*micrograms per milliliter Geometric Coefficient of Variation 56.1	60.6 Hour*micrograms per milliliter Geometric Coefficient of Variation 30.6	55.1 Hour*micrograms per milliliter Geometric Coefficient of Variation 44.3	42.6 Hour*micrograms per milliliter Geometric Coefficient of Variation 21.5	—

SECONDARY outcome

Timeframe: Day 8: pre-evening dose, 1,2,3,4,5,6,8 hours

Population: PK Population

Blood samples were collected at indicated time points to assess AUC (0-24) of BMS-626529 following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8.

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
AUC (0-24) of BMS-626529 Following QHS Dosing	23.0 Hour*micrograms per milliliter Geometric Coefficient of Variation 48.2	—	—	—	—

SECONDARY outcome

Timeframe: Day 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours

Population: PK Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected at indicated time points to assess Accumulation Index of BMS-626529 following Q12H dosing. AI was calculated as ratio of AUC(tau) at steady-state to AUC(tau) after the first dose. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8 morning dose (AM).

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=9 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM n=10 Participants All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Accumulation Index (AI) of BMS-626529 Following Q12H Dosing	1.53 Ratio of AUC Geometric Coefficient of Variation 49.4	1.63 Ratio of AUC Geometric Coefficient of Variation 26.7	1.34 Ratio of AUC Geometric Coefficient of Variation 25.4	1.42 Ratio of AUC Geometric Coefficient of Variation 37.0	—

SECONDARY outcome

Timeframe: Day 8: pre-evening dose, 1,2,3,4,5,6,8 hours

Population: PK Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected at indicated time points to assess Accumulation Index of BMS-626529 following QHS dosing. AI was calculated as ratio of AUC(tau) at steady-state to AUC(tau) after the first dose. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8 evening dose (PM).

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=9 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Accumulation Index of BMS-626529 Following QHS Dosing	0.912 Ratio of AUC Geometric Coefficient of Variation 27.1	—	—	—	—

SECONDARY outcome

Timeframe: Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours; Day 9: pre-dose, 4,12 hours; Day 10: pre-dose, 12 hours; Day 11: pre-dose; Days 5,6,7: pre-morning dose

Population: PK Population. Only those participants with data available at the specified time points were analyzed. No evidence of a correlation between changes in viral load from Baseline (on Day 9 or the nadir) and the BMS-626529 PK parameters was found. Log10 PBA EC90 and IQs of Cmin and Css,avg were found to correlate with antiviral activity.

Blood samples were collected at indicated time points to assess IQ of BMS-626529. Inhibitory quotient was calculated as the ratio of BMS-626529 in vivo exposure to in vitro measured protein binding adjusted EC90 (PBA-EC90). The following in vivo exposure measures were used in evaluating IQ: Cmin and Css,avg. Geometric mean and geometric coefficient of variation are presented.

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=8 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS n=9 Participants All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM n=10 Participants All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Inhibitory Quotient (IQ) of BMS-626529 by Css,Avg and by Lowest Concentration of a Drug During Dosing Interval (Cmin) Following Q12H Dosing IQ Cmin	11.0 Ratio Geometric Coefficient of Variation 3510	97.5 Ratio Geometric Coefficient of Variation 382	67.2 Ratio Geometric Coefficient of Variation 543	4.54 Ratio Geometric Coefficient of Variation 21600	—
Inhibitory Quotient (IQ) of BMS-626529 by Css,Avg and by Lowest Concentration of a Drug During Dosing Interval (Cmin) Following Q12H Dosing IQ Css,avg	29.7 Ratio Geometric Coefficient of Variation 4040	327 Ratio Geometric Coefficient of Variation 454	252 Ratio Geometric Coefficient of Variation 789	15.4 Ratio Geometric Coefficient of Variation 14900	—

SECONDARY outcome

Timeframe: Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours; Day 2: pre-evening dose, 12,16 hours; Day 9: pre-dose, 12,16 hours; Day 10: pre-dose, 12 hours; Day 11: pre-dose; Days 5,6,7: pre-evening dose

Population: PK Population. Only those participants with data available at the specified time points were analyzed. No evidence of a correlation between changes in viral load from Baseline (on Day 9 or the nadir) and the BMS-626529 PK parameters was found. Log10 PBA EC90 and IQs of Cmin and Css,avg were found to correlate with antiviral activity.

Blood samples were collected at indicated time points to assess IQ of BMS-626529. Inhibitory quotient was calculated as the ratio of BMS-626529 in vivo exposure to in vitro measured protein binding adjusted EC90 (PBA-EC90). The following in vivo exposure measures were used in evaluating IQ: Cmin and Css,avg. Geometric mean and geometric coefficient of variation are presented.

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=9 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Inhibitory Quotient (IQ) of BMS-626529 by Css,Avg and by Lowest Concentration of a Drug During Dosing Interval (Cmin) Following QHS Dosing IQ Cmin	3.86 Ratio Geometric Coefficient of Variation 1070	—	—	—	—
Inhibitory Quotient (IQ) of BMS-626529 by Css,Avg and by Lowest Concentration of a Drug During Dosing Interval (Cmin) Following QHS Dosing IQ Css,avg	67.8 Ratio Geometric Coefficient of Variation 902	—	—	—	—

SECONDARY outcome

Timeframe: Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours; Day 9: pre-dose, 4,12 hours; Day 10: pre-dose, 12 hours; Day 11: pre-dose; Days 5,6,7: pre-morning dose

Population: PK Population. Only those participants with data available at the specified time points were analyzed. No evidence of a correlation between changes in viral load from Baseline (on Day 9 or the nadir) and the BMS-626529 PK parameters was found. Log10 PBA EC90 and IQs of Cmin and Css,avg were found to correlate with antiviral activity.

Blood samples were collected at indicated time points to assess IQ of BMS-626529. Inhibitory quotient was calculated as the ratio of BMS-626529 in vivo exposure to in vitro measured protein binding adjusted EC90 (PBA-EC90). The following in vivo exposure measure was used in evaluating IQ: Ctrough. Geometric mean and geometric coefficient of variation are presented.

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=8 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS n=9 Participants All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM n=10 Participants All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Inhibitory Quotient of BMS-626529 by Ctrough Following Q12H Dosing	12.2 Ratio Geometric Coefficient of Variation 2750	120 Ratio Geometric Coefficient of Variation 568	87.3 Ratio Geometric Coefficient of Variation 763	4.61 Ratio Geometric Coefficient of Variation 19000	—

SECONDARY outcome

Timeframe: Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours; Days 2: pre-evening dose, 12,16 hours; Day 9: pre-dose, 12,16 hours; Day 10: pre-dose, 12 hours; Day 11: pre-dose; Days 5,6,7: pre-evening dose

Population: PK Population. Only those participants with data available at the specified time points were analyzed. No evidence of a correlation between changes in viral load from Baseline (on Day 9 or the nadir) and the BMS-626529 PK parameters was found. Log10 PBA EC90 and IQs of Cmin and Css,avg were found to correlate with antiviral activity.

Blood samples were collected at indicated time points to assess IQ of BMS-626529. Inhibitory quotient was calculated as the ratio of BMS-626529 in vivo exposure to in vitro measured protein binding adjusted EC90 (PBA-EC90). The following in vivo exposure measure was used in evaluating IQ: Ctrough. Geometric mean and geometric coefficient of variation are presented.

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=9 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Inhibitory Quotient of BMS-626529 by Ctrough Following QHS Dosing	4.77 Ratio Geometric Coefficient of Variation 1010	—	—	—	—

SECONDARY outcome

Timeframe: Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours

Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points to assess Cmax of ritonavir following Q12H dosing. Geometric mean and geometric coefficient of variation are presented for Day 1, Day 8 morning dose (AM), Day 8 evening dose (PM) and Day 8 morning + evening dose (AM+PM). Pharmacokinetic parameter values were derived by non-compartmental methods. PK Population was used which comprised of all participants who receive ritonavir and provided pharmacokinetic samples.

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Cmax of Ritonavir Following Q12H Dosing Day 1, n=10,10,10	0.330 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 91.3	0.314 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 111	0.294 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 59.6	—	—
Cmax of Ritonavir Following Q12H Dosing Day 8, AM, n=9,10,10	1.31 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 101	1.30 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 58.3	0.841 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 44.9	—	—
Cmax of Ritonavir Following Q12H Dosing Day 8, PM, n=9,10,0	1.24 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 73.4	1.48 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 47.7	—	—	—
Cmax of Ritonavir Following Q12H Dosing Day 8, AM+PM, n=9,10,10	1.27 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 80.0	1.39 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 50.7	0.841 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 44.9	—	—

SECONDARY outcome

Timeframe: Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours

Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points to assess Cmax of ritonavir following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Day 8 evening dose (PM) and Day 8 morning (AM) + evening dose (PM).

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Cmax of Ritonavir Following QHS Dosing Day 1, n=10	0.257 μg/mL Geometric Coefficient of Variation 53.8	—	—	—	—
Cmax of Ritonavir Following QHS Dosing Day 8, PM, n=9	0.628 μg/mL Geometric Coefficient of Variation 56.4	—	—	—	—
Cmax of Ritonavir Following QHS Dosing Day 8, AM+PM, n=9	0.628 μg/mL Geometric Coefficient of Variation 56.4	—	—	—	—

SECONDARY outcome

Timeframe: Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours; Days 5,6,7: pre-morning dose

Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points to access Ctrough of ritonavir following Q12H dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Days 5, 6, 7, 8, Day 8 morning dose (AM) and Day 8 evening dose (PM).

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Ctrough of Ritonavir Following Q12H Dosing Day 1, n=10,10,0	0.117 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 90.1	0.131 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 98.2	—	—	—
Ctrough of Ritonavir Following Q12H Dosing Day 5, n=9,10,10	0.502 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 84.3	0.554 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 73.9	0.0831 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 77.8	—	—
Ctrough of Ritonavir Following Q12H Dosing Day 6, n=9,10,10	0.526 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 87.9	0.594 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 77.0	0.0820 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 77.9	—	—
Ctrough of Ritonavir Following Q12H Dosing Day 7, n=9,10,10	0.477 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 93.5	0.587 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 76.3	0.0860 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 79.9	—	—
Ctrough of Ritonavir Following Q12H Dosing Day 8, n=9,10,10	0.470 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 90.6	0.503 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 73.2	0.0891 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 81.7	—	—
Ctrough of Ritonavir Following Q12H Dosing Day 8, AM, n=9,10,10	0.345 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 105	0.393 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 66.3	0.0912 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 70.5	—	—
Ctrough of Ritonavir Following Q12H Dosing Day 8, PM, n=9,10,0	0.453 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 86.2	0.476 Micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 77.9	—	—	—

SECONDARY outcome

Timeframe: Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours; Days 5,6,7: pre-evening dose

Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points to assess Ctrough of ritonavir following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Days 5, 6, 7, 8 and Day 8 evening dose (PM).

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Ctrough of Ritonavir Following QHS Dosing Day 1, n=10	0.157 μg/mL Geometric Coefficient of Variation 87.0	—	—	—	—
Ctrough of Ritonavir Following QHS Dosing Day 5, n=9	0.107 μg/mL Geometric Coefficient of Variation 69.4	—	—	—	—
Ctrough of Ritonavir Following QHS Dosing Day 6, n=9	0.0845 μg/mL Geometric Coefficient of Variation 67.7	—	—	—	—
Ctrough of Ritonavir Following QHS Dosing Day 7, n=9	0.0844 μg/mL Geometric Coefficient of Variation 65.0	—	—	—	—
Ctrough of Ritonavir Following QHS Dosing Day 8, n=9	0.0808 μg/mL Geometric Coefficient of Variation 73.2	—	—	—	—
Ctrough of Ritonavir Following QHS Dosing Day 8, PM, n=9	0.0830 μg/mL Geometric Coefficient of Variation 71.7	—	—	—	—

SECONDARY outcome

Timeframe: Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours

Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points to assess AUC (tau) of ritonavir following Q12H dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Day 8 morning dose (AM) and Day 8 evening dose (PM).

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
AUC (Tau) of Ritonavir Following Q12H Dosing Day 1, n=10,10,0	2.37 Hour*micrograms per milliliter Geometric Coefficient of Variation 99.5	2.05 Hour*micrograms per milliliter Geometric Coefficient of Variation 104	—	—	—
AUC (Tau) of Ritonavir Following Q12H Dosing Day 8, AM, n=9,10,10	9.43 Hour*micrograms per milliliter Geometric Coefficient of Variation 89.1	9.05 Hour*micrograms per milliliter Geometric Coefficient of Variation 62.8	6.76 Hour*micrograms per milliliter Geometric Coefficient of Variation 49.3	—	—
AUC (Tau) of Ritonavir Following Q12H Dosing Day 8, PM, n=9,10,0	9.23 Hour*micrograms per milliliter Geometric Coefficient of Variation 77.1	10.4 Hour*micrograms per milliliter Geometric Coefficient of Variation 52.4	—	—	—

SECONDARY outcome

Timeframe: Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours

Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points to assess AUC (tau) of ritonavir following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1 and Day 8 evening dose (PM).

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
AUC (Tau) of Ritonavir Following QHS Dosing Day 1, n=10	2.91 Hour*micrograms per milliliter Geometric Coefficient of Variation 80.4	—	—	—	—
AUC (Tau) of Ritonavir Following QHS Dosing Day 8 PM, n=9	6.13 Hour*micrograms per milliliter Geometric Coefficient of Variation 94.3	—	—	—	—

SECONDARY outcome

Timeframe: Day 8: pre-morning dose, 1,2,3,4,5,6,8,12, 13,14,15,16,17,18,20 hours

Population: PK Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected at indicated time points to assess AUC (0-24) of ritonavir following Q12H dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8.

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=9 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
AUC (0-24) of Ritonavir Following Q12H Dosing	18.9 Hour*micrograms per milliliter Geometric Coefficient of Variation 80.0	19.5 Hour*micrograms per milliliter Geometric Coefficient of Variation 56.6	6.76 Hour*micrograms per milliliter Geometric Coefficient of Variation 49.3	—	—

SECONDARY outcome

Timeframe: Day 8: pre-evening dose, 1,2,3,4,5,6,8 hours

Population: PK Population

Blood samples were collected at indicated time points to assess AUC (0-24) of ritonavir following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8.

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=9 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
AUC (0-24) of Ritonavir Following QHS Dosing	6.13 Hour*micrograms per milliliter Geometric Coefficient of Variation 94.3	—	—	—	—

SECONDARY outcome

Timeframe: Day 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours

Population: PK Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected at indicated time points to assess Accumulation Index of ritonavir following Q12H dosing. AI was calculated as ratio of AUC(tau) at steady-state to AUC(tau) after the first dose. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8 morning dose (AM).

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=9 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H n=10 Participants All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Accumulation Index of Ritonavir Following Q12H Dosing	3.58 Ratio of AUC Geometric Coefficient of Variation 64.0	4.41 Ratio of AUC Geometric Coefficient of Variation 41.7	3.62 Ratio of AUC Geometric Coefficient of Variation 39.8	—	—

SECONDARY outcome

Timeframe: Day 8: pre-evening dose, 1,2,3,4,5,6,8 hours

Population: PK Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected at indicated time points to assess Accumulation Index of ritonavir following QHS dosing. AI was calculated as ratio of AUC(tau) at steady-state to AUC(tau) after the first dose. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8 evening dose (PM).

Outcome measures

Outcome measures
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=9 Participants All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Accumulation Index of Ritonavir Following QHS Dosing	2.19 Ratio of AUC Geometric Coefficient of Variation 16.2	—	—	—	—

Adverse Events

BMS-663068 600 mg Q12H + RTV 100 mg Q12H

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

BMS-663068 1200 mg QHS + RTV 100 mg QHS

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

BMS-663068 1200 mg Q12H + RTV 100 mg Q12H

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

BMS-663068 1200 mg Q12H + RTV 100 mg QAM

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

BMS-663068 1200 mg Q12H

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BMS-663068 600 mg Q12H + RTV 100 mg Q12H n=10 participants at risk All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8.	BMS-663068 1200 mg QHS + RTV 100 mg QHS n=10 participants at risk All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg Q12H n=10 participants at risk All participants received BMS-663068 1200 mg and RTV 100 mg Q12H from Day 1 to Day 8.	BMS-663068 1200 mg Q12H + RTV 100 mg QAM n=10 participants at risk All participants received BMS-663068 1200 mg Q12H and RTV 100 mg every 24 hours in the morning (quaque ante meridiem \[QAM\]) from Day 1 to Day 8.	BMS-663068 1200 mg Q12H n=10 participants at risk All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8.
Cardiac disorders PALPITATIONS	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Eye disorders EYE PRURITUS	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Gastrointestinal disorders DIARRHOEA	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	20.0% 2/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Gastrointestinal disorders NAUSEA	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Gastrointestinal disorders TOOTHACHE	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	20.0% 2/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
General disorders ASTHENIA	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
General disorders CHEST PAIN	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
General disorders DISCOMFORT	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
General disorders FATIGUE	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
General disorders INFLUENZA LIKE ILLNESS	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Infections and infestations ABSCESS JAW	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Infections and infestations GONORRHOEA	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Infections and infestations NASOPHARYNGITIS	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	30.0% 3/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	20.0% 2/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Infections and infestations RHINITIS	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Musculoskeletal and connective tissue disorders FLANK PAIN	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Nervous system disorders DIZZINESS	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Nervous system disorders HEADACHE	40.0% 4/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	30.0% 3/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	40.0% 4/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	30.0% 3/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	40.0% 4/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Nervous system disorders NEURALGIA	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Nervous system disorders PRESYNCOPE	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Nervous system disorders SYNCOPE	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Psychiatric disorders DISORIENTATION	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	20.0% 2/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Psychiatric disorders LISTLESS	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Renal and urinary disorders MICTURITION URGENCY	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	30.0% 3/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Skin and subcutaneous tissue disorders BLISTER	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Skin and subcutaneous tissue disorders DRY SKIN	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Skin and subcutaneous tissue disorders ERYTHEMA	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	20.0% 2/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Skin and subcutaneous tissue disorders PRURITUS	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Skin and subcutaneous tissue disorders RASH	20.0% 2/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	20.0% 2/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	20.0% 2/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.
Skin and subcutaneous tissue disorders RASH PRURITIC	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	10.0% 1/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.	0.00% 0/10 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 50 days. SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who used the trial medication at least once.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER