HIV Infections
Conditions
Keywords
HIV, HIV attachment inhibitor, attachment inhibitor
Brief summary
Research Hypothesis: Administration of BMS-663068, a prodrug for HIV attachment inhibitor BMS-626529, will result in a mean decrease of at least 1 log10 in HIV RNA at Day 9 following 8 days of therapy in at least one dosing regimen that is safe and well tolerated in Clade B HIV-1 infected subjects.
Interventions
DRUGBMS-663068
BMS-663068 will be administered as a tablet formulation
DRUGRitonavir
Ritonavir will be administered as a capsule.
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clade B HIV-1 infected subjects meeting following criteria at screening: * Plasma HIV RNA ≥ 5,000 copies/mL * CD4+ lymphocyte ≥ 200 cells/µL * Antiretroviral naive or experienced * Off all ARV therapy with HIV activity for \> 8 weeks * BMI of 18 to 35 kg/m2, inclusive. * Not currently co-infected with HCV or HBV * Men and women, ≥ 18 years of age
Exclusion criteria
* Woman of childbearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period up to 12 weeks after the last dose of study drug. * WOCBP using prohibited contraceptive method including oral, injectable, or implantable hormonal contraceptive agent within 12 weeks of enrollment. * Women who are pregnant or breastfeeding. * Women with positive pregnancy test on enrollment or prior to study drug intake. * Sexually active fertile men not using effective birth control during study and for at least 12 weeks after last dose of study drug if partners are WOCBP. * Significant acute or chronic medical illness not stable or not controlled with medication or not consistent with HIV infection. * Current or recent (within 3 months) gastrointestinal disease that, in the opinion of Investigator or Medical Monitor, may impact on drug absorption and/or put subject at risk for GI tract irritation and/or bleeding. * Acute diarrhea lasting ≥ 1 day, within 3 weeks prior to randomization. * Major surgery within 4 weeks of study drug intake. * Gastrointestinal surgery that could impact upon absorption of study drug. * Donation of blood or plasma to blood bank or in a clinical study (except a Screening visit or follow up visit of less than 50 mL) within 4 weeks of study drug intake. * Blood transfusion within 4 weeks of study drug intake. * Inability to tolerate oral medication. * Inability to be venipunctured and/or tolerate venous access. * Personal history of clinically relevant cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de pointes. * Personal or family history of long QT syndrome. * Recent (within 6 months) drug/alcohol abuse * Any other medical, psychiatric and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation. * Evidence of organ dysfunction or clinically significant deviation from normal in physical examination, vital signs, ECG or clinical lab determinations or not consistent with subject's degree of HIV infection. * Evidence of 2nd or 3rd degree heart block at screening or Day -1 * Positive urine drug screen at Screening or Day -1 without valid prescription (subjects positive for cannabinoids and/or amphetamines will be included). * Positive blood screen for hepatitis B surface antigen. * Positive blood screen for hepatitis C antibody and hepatitis C RNA. * History of significant drug allergy * Exposure to any investigational drug or placebo within 4 weeks of study drug intake. * Prescription drugs within 4 weeks prior to study drug intake, unless approved by BMS medical monitor. * Other drugs, including over-the-counter medications, vitamins and/or herbal preparations, within 1 week prior to study drug intake, unless approved by BMS medical monitor. * Use of oral, injectable or implantable hormonal contraceptive agent within 12 weeks of study drug intake. * Use of prescription drugs or OTC drugs that may cause GI tract irritation or bleeding within 2 weeks of study drug intake, unless approved by BMS medical monitor. * Use of alcohol-containing beverages within 3 days prior to study drug intake. * Use of grapefruit, grapefruit-containing or Seville orange-containing products within 7 days prior to study drug intake. * Prisoners or subjects involuntarily incarcerated. * Subjects compulsorily detained for treatment of either a psychiatric or physical illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Logarithm With Base 10 (Log10) Change From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) at Day 9 | Baseline and Day 9 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Baseline (Day 1 pre-dose), Day 8, Day 15 and Day 50 | 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. |
| Number of Participants With Treatment Emergent Non-serious Adverse Event (Non-SAE) and Serious AE (SAE) | Up to 50 days | 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. |
| Number of Participants With Any Abnormality in Physical Examination | Up to 50 days | 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. |
| Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Up to 50 days | 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. |
| Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | Up to 50 days | 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. |
| Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | Up to 50 days | 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. |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Up to 50 days | 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. |
| Maximum Observed Plasma Concentration (Cmax) of BMS-626529 Following Q12H Dosing | 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 | 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. |
| Cmax of BMS-626529 Following QHS Dosing | Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours | 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). |
| Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing | 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 | 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). |
| Ctrough of BMS-626529 Following QHS Dosing | Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours; Days 5,6,7: pre-evening dose | 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). |
| Area Under the Concentration-time Curve in One Dosing Interval (AUC [Tau]) of BMS-626529 Following Q12H Dosing | 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 | 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). |
| AUC (Tau) of BMS-626529 Following QHS Dosing | Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours | 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). |
| Area Under the Concentration-time Curve Over a 24-hour Period (AUC [0-24]) of BMS-626529 Following Q12H Dosing | Day 8: pre-morning dose, 1,2,3,4,5,6,8,12, 13,14,15,16,17,18,20 hours | 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. |
| AUC (0-24) of BMS-626529 Following QHS Dosing | Day 8: pre-evening dose, 1,2,3,4,5,6,8 hours | 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. |
| Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count and Cluster of Differentiation 8 Positive (CD8+) Cell Count | Baseline (Day 1 pre-dose), Day 8, Day 15 and Day 50 | 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. |
| Accumulation Index of BMS-626529 Following QHS Dosing | Day 8: pre-evening dose, 1,2,3,4,5,6,8 hours | 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). |
| Inhibitory Quotient (IQ) of BMS-626529 by Css,Avg and by Lowest Concentration of a Drug During Dosing Interval (Cmin) Following Q12H Dosing | 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 | 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. |
| Inhibitory Quotient (IQ) of BMS-626529 by Css,Avg and by Lowest Concentration of a Drug During Dosing Interval (Cmin) Following QHS Dosing | 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 | 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. |
| Inhibitory Quotient of BMS-626529 by Ctrough Following Q12H Dosing | 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 | 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. |
| Inhibitory Quotient of BMS-626529 by Ctrough Following QHS Dosing | 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 | 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. |
| Cmax of Ritonavir Following Q12H Dosing | 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 | 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. |
| Cmax of Ritonavir Following QHS Dosing | Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours | 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). |
| Ctrough of Ritonavir Following Q12H Dosing | 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 | 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). |
| Ctrough of Ritonavir Following QHS Dosing | Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours; Days 5,6,7: pre-evening dose | 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). |
| AUC (Tau) of Ritonavir Following Q12H Dosing | 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 | 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). |
| AUC (Tau) of Ritonavir Following QHS Dosing | Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours | 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). |
| AUC (0-24) of Ritonavir Following Q12H Dosing | Day 8: pre-morning dose, 1,2,3,4,5,6,8,12, 13,14,15,16,17,18,20 hours | 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. |
| AUC (0-24) of Ritonavir Following QHS Dosing | Day 8: pre-evening dose, 1,2,3,4,5,6,8 hours | 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. |
| Accumulation Index of Ritonavir Following Q12H Dosing | Day 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours | 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). |
| Accumulation Index of Ritonavir Following QHS Dosing | Day 8: pre-evening dose, 1,2,3,4,5,6,8 hours | 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). |
| Accumulation Index (AI) of BMS-626529 Following Q12H Dosing | Day 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours | 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). |
Countries
Germany
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 10 |
| 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. | 10 |
| 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. | 10 |
| BMS-663068 1200 mg Q12H All participants received BMS-663068 1200 mg Q12H from Day 1 to Day 8. | 10 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | No longer met study criteria | 1 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | BMS-663068 600 mg Q12H + RTV 100 mg Q12H | BMS-663068 1200 mg QHS + RTV 100 mg QHS | BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | BMS-663068 1200 mg Q12H + RTV 100 mg QAM | BMS-663068 1200 mg Q12H | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 41.3 Years STANDARD_DEVIATION 8.29 | 40.7 Years STANDARD_DEVIATION 13.7 | 40.7 Years STANDARD_DEVIATION 6.53 | 38.4 Years STANDARD_DEVIATION 7.83 | 42.7 Years STANDARD_DEVIATION 8.42 | 40.8 Years STANDARD_DEVIATION 9.01 |
| Race/Ethnicity, Customized Race White | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 50 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 9 Participants | 10 Participants | 10 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 8 / 10 | 5 / 10 | 9 / 10 | 8 / 10 | 9 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Mean Logarithm With Base 10 (Log10) Change From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) at Day 9
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Mean Logarithm With Base 10 (Log10) Change From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) at Day 9 | -1.2532 Log10 copies per milliliter (c/mL) | Standard Error 0.1061 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Mean Logarithm With Base 10 (Log10) Change From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) at Day 9 | -1.2381 Log10 copies per milliliter (c/mL) | Standard Error 0.10455 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Mean Logarithm With Base 10 (Log10) Change From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) at Day 9 | -1.1888 Log10 copies per milliliter (c/mL) | Standard Error 0.12938 |
| BMS-663068 1200 mg Q12H | Mean Logarithm With Base 10 (Log10) Change From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) at Day 9 | -0.8760 Log10 copies per milliliter (c/mL) | Standard Error 0.22621 |
Comparison: Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.p-value: 0.610290% CI: [-0.4656, 0.2477]ANCOVA
Comparison: Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.p-value: 0.545290% CI: [-0.4758, 0.2225]ANCOVA
Comparison: Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.p-value: 0.417890% CI: [-0.5139, 0.1775]ANCOVA
Comparison: Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.p-value: 0.023390% CI: [-0.8375, -0.1395]ANCOVA
Comparison: Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.p-value: 0.931490% CI: [-0.3613, 0.3259]ANCOVA
Comparison: Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.p-value: 0.773490% CI: [-0.4032, 0.2847]ANCOVA
Comparison: Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.p-value: 0.070290% CI: [-0.7232, -0.036]ANCOVA
Comparison: Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.p-value: 0.835990% CI: [-0.3768, 0.2937]ANCOVA
Comparison: Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.p-value: 0.075990% CI: [-0.6962, -0.0275]ANCOVA
Comparison: Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.p-value: 0.115590% CI: [-0.6555, 0.0149]ANCOVA
Secondary
Accumulation Index (AI) of BMS-626529 Following Q12H Dosing
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).
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Accumulation Index (AI) of BMS-626529 Following Q12H Dosing | 1.53 Ratio of AUC | Geometric Coefficient of Variation 49.4 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Accumulation Index (AI) of BMS-626529 Following Q12H Dosing | 1.63 Ratio of AUC | Geometric Coefficient of Variation 26.7 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Accumulation Index (AI) of BMS-626529 Following Q12H Dosing | 1.34 Ratio of AUC | Geometric Coefficient of Variation 25.4 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Accumulation Index (AI) of BMS-626529 Following Q12H Dosing | 1.42 Ratio of AUC | Geometric Coefficient of Variation 37 |
Secondary
Accumulation Index of BMS-626529 Following QHS Dosing
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).
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Accumulation Index of BMS-626529 Following QHS Dosing | 0.912 Ratio of AUC | Geometric Coefficient of Variation 27.1 |
Secondary
Accumulation Index of Ritonavir Following Q12H Dosing
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).
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Accumulation Index of Ritonavir Following Q12H Dosing | 3.58 Ratio of AUC | Geometric Coefficient of Variation 64 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Accumulation Index of Ritonavir Following Q12H Dosing | 4.41 Ratio of AUC | Geometric Coefficient of Variation 41.7 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Accumulation Index of Ritonavir Following Q12H Dosing | 3.62 Ratio of AUC | Geometric Coefficient of Variation 39.8 |
Secondary
Accumulation Index of Ritonavir Following QHS Dosing
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).
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Accumulation Index of Ritonavir Following QHS Dosing | 2.19 Ratio of AUC | Geometric Coefficient of Variation 16.2 |
Secondary
Area Under the Concentration-time Curve in One Dosing Interval (AUC [Tau]) of BMS-626529 Following Q12H Dosing
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).
Time frame: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | 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 | 18.3 Hour*micrograms per milliliter | Geometric Coefficient of Variation 28.8 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | 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 | 30.6 Hour*micrograms per milliliter | Geometric Coefficient of Variation 26.3 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | 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 | 29.9 Hour*micrograms per milliliter | Geometric Coefficient of Variation 37 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | 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 | 27.6 Hour*micrograms per milliliter | Geometric Coefficient of Variation 48.4 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | 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 | 20.6 Hour*micrograms per milliliter | Geometric Coefficient of Variation 45 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | 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 | 27.0 Hour*micrograms per milliliter | Geometric Coefficient of Variation 45.2 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | 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 | 13.8 Hour*micrograms per milliliter | Geometric Coefficient of Variation 28.3 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | 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 | 22.5 Hour*micrograms per milliliter | Geometric Coefficient of Variation 34 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | 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 | 19.5 Hour*micrograms per milliliter | Geometric Coefficient of Variation 20.5 |
Secondary
Area Under the Concentration-time Curve Over a 24-hour Period (AUC [0-24]) of BMS-626529 Following Q12H Dosing
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.
Time frame: Day 8: pre-morning dose, 1,2,3,4,5,6,8,12, 13,14,15,16,17,18,20 hours
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Area Under the Concentration-time Curve Over a 24-hour Period (AUC [0-24]) of BMS-626529 Following Q12H Dosing | 60.6 Hour*micrograms per milliliter | Geometric Coefficient of Variation 30.6 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Area Under the Concentration-time Curve Over a 24-hour Period (AUC [0-24]) of BMS-626529 Following Q12H Dosing | 55.1 Hour*micrograms per milliliter | Geometric Coefficient of Variation 44.3 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Area Under the Concentration-time Curve Over a 24-hour Period (AUC [0-24]) of BMS-626529 Following Q12H Dosing | 42.6 Hour*micrograms per milliliter | Geometric Coefficient of Variation 21.5 |
Secondary
AUC (0-24) of BMS-626529 Following QHS Dosing
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.
Time frame: Day 8: pre-evening dose, 1,2,3,4,5,6,8 hours
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | AUC (0-24) of BMS-626529 Following QHS Dosing | 23.0 Hour*micrograms per milliliter | Geometric Coefficient of Variation 48.2 |
Secondary
AUC (0-24) of Ritonavir Following Q12H Dosing
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.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | AUC (0-24) of Ritonavir Following Q12H Dosing | 18.9 Hour*micrograms per milliliter | Geometric Coefficient of Variation 80 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | AUC (0-24) of Ritonavir Following Q12H Dosing | 19.5 Hour*micrograms per milliliter | Geometric Coefficient of Variation 56.6 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | AUC (0-24) of Ritonavir Following Q12H Dosing | 6.76 Hour*micrograms per milliliter | Geometric Coefficient of Variation 49.3 |
Secondary
AUC (0-24) of Ritonavir Following QHS Dosing
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.
Time frame: Day 8: pre-evening dose, 1,2,3,4,5,6,8 hours
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | AUC (0-24) of Ritonavir Following QHS Dosing | 6.13 Hour*micrograms per milliliter | Geometric Coefficient of Variation 94.3 |
Secondary
AUC (Tau) of BMS-626529 Following QHS Dosing
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).
Time frame: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | AUC (Tau) of BMS-626529 Following QHS Dosing | Day 1, n=10 | 25.5 Hour*micrograms per milliliter | Geometric Coefficient of Variation 38 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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
AUC (Tau) of Ritonavir Following Q12H Dosing
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).
Time frame: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | AUC (Tau) of Ritonavir Following Q12H Dosing | Day 8, AM, n=9,10,10 | 9.05 Hour*micrograms per milliliter | Geometric Coefficient of Variation 62.8 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | AUC (Tau) of Ritonavir Following Q12H Dosing | Day 1, n=10,10,0 | 2.05 Hour*micrograms per milliliter | Geometric Coefficient of Variation 104 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | AUC (Tau) of Ritonavir Following Q12H Dosing | Day 8, PM, n=9,10,0 | 10.4 Hour*micrograms per milliliter | Geometric Coefficient of Variation 52.4 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | AUC (Tau) of Ritonavir Following Q12H Dosing | Day 8, AM, n=9,10,10 | 6.76 Hour*micrograms per milliliter | Geometric Coefficient of Variation 49.3 |
Secondary
AUC (Tau) of Ritonavir Following QHS Dosing
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).
Time frame: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | AUC (Tau) of Ritonavir Following QHS Dosing | Day 1, n=10 | 2.91 Hour*micrograms per milliliter | Geometric Coefficient of Variation 80.4 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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
Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count and Cluster of Differentiation 8 Positive (CD8+) Cell Count
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | 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 | -153.2 Cells per microliter (cells/μL) | Standard Error 137.18 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | 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 | -292.4 Cells per microliter (cells/μL) | Standard Error 121.73 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | 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 | 93.4 Cells per microliter (cells/μL) | Standard Error 25.12 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | 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 | -50.3 Cells per microliter (cells/μL) | Standard Error 18.06 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | 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 | 189.0 Cells per microliter (cells/μL) | Standard Error 134.27 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | 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 | -6.1 Cells per microliter (cells/μL) | Standard Error 28.15 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | 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 | 218.4 Cells per microliter (cells/μL) | Standard Error 125.65 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | 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 | 85.6 Cells per microliter (cells/μL) | Standard Error 112.65 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | 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 | 109.8 Cells per microliter (cells/μL) | Standard Error 32.37 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | 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 | 71.1 Cells per microliter (cells/μL) | Standard Error 28.55 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | 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 | 117.6 Cells per microliter (cells/μL) | Standard Error 27.67 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | 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 | 139.7 Cells per microliter (cells/μL) | Standard Error 95 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | 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 | 114.9 Cells per microliter (cells/μL) | Standard Error 131.64 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | 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 | 44.6 Cells per microliter (cells/μL) | Standard Error 69.94 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | 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 | -48.4 Cells per microliter (cells/μL) | Standard Error 61.21 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | 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 | 6.0 Cells per microliter (cells/μL) | Standard Error 170.29 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | 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 | -99.6 Cells per microliter (cells/μL) | Standard Error 159.83 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | 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 | 38.5 Cells per microliter (cells/μL) | Standard Error 41.61 |
| BMS-663068 1200 mg Q12H | 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 | -4.4 Cells per microliter (cells/μL) | Standard Error 126.77 |
| BMS-663068 1200 mg Q12H | 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 | -19.2 Cells per microliter (cells/μL) | Standard Error 17.05 |
| BMS-663068 1200 mg Q12H | 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 | 10.4 Cells per microliter (cells/μL) | Standard Error 23.38 |
| BMS-663068 1200 mg Q12H | 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 | -48.2 Cells per microliter (cells/μL) | Standard Error 140.55 |
| BMS-663068 1200 mg Q12H | 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 | 94.6 Cells per microliter (cells/μL) | Standard Error 152.73 |
| BMS-663068 1200 mg Q12H | 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 | 32.0 Cells per microliter (cells/μL) | Standard Error 36.23 |
Secondary
Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD8+, Day 15, n=9, 9, 10, 10, 10 | -2.8 Percent cells per microliter | Standard Error 1 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD8+, Day 50, n=9, 9, 10, 10, 9 | -0.7 Percent cells per microliter | Standard Error 1.22 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD4+, Day 8, n=9, 9, 10, 10, 10 | 1.2 Percent cells per microliter | Standard Error 0.97 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD4+, Day 50, n=9, 9, 10, 10, 9 | 1.1 Percent cells per microliter | Standard Error 1.15 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD8+, Day 8, n=9, 9, 10, 10, 10 | -0.4 Percent cells per microliter | Standard Error 1.02 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD4+, Day 15, n=9, 9, 10, 10, 10 | 1.2 Percent cells per microliter | Standard Error 0.64 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD8+, Day 8, n=9, 9, 10, 10, 10 | 0.1 Percent cells per microliter | Standard Error 1.06 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD8+, Day 15, n=9, 9, 10, 10, 10 | -2.9 Percent cells per microliter | Standard Error 1.49 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD4+, Day 8, n=9, 9, 10, 10, 10 | 0.6 Percent cells per microliter | Standard Error 0.78 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD4+, Day 50, n=9, 9, 10, 10, 9 | 0.3 Percent cells per microliter | Standard Error 0.9 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD4+, Day 15, n=9, 9, 10, 10, 10 | 1.4 Percent cells per microliter | Standard Error 1.33 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD8+, Day 50, n=9, 9, 10, 10, 9 | -0.9 Percent cells per microliter | Standard Error 1.19 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD8+, Day 8, n=9, 9, 10, 10, 10 | -0.3 Percent cells per microliter | Standard Error 1.11 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD4+, Day 15, n=9, 9, 10, 10, 10 | 2.4 Percent cells per microliter | Standard Error 1.11 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD4+, Day 50, n=9, 9, 10, 10, 9 | -1.7 Percent cells per microliter | Standard Error 0.97 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD8+, Day 50, n=9, 9, 10, 10, 9 | 1.6 Percent cells per microliter | Standard Error 1.52 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD8+, Day 15, n=9, 9, 10, 10, 10 | -4.0 Percent cells per microliter | Standard Error 1.73 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD4+, Day 8, n=9, 9, 10, 10, 10 | 0.1 Percent cells per microliter | Standard Error 0.72 |
| BMS-663068 1200 mg Q12H | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD8+, Day 15, n=9, 9, 10, 10, 10 | -2.9 Percent cells per microliter | Standard Error 1.16 |
| BMS-663068 1200 mg Q12H | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD4+, Day 50, n=9, 9, 10, 10, 9 | 0.6 Percent cells per microliter | Standard Error 1.45 |
| BMS-663068 1200 mg Q12H | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD4+, Day 15, n=9, 9, 10, 10, 10 | 0.9 Percent cells per microliter | Standard Error 1.51 |
| BMS-663068 1200 mg Q12H | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD8+, Day 50, n=9, 9, 10, 10, 9 | -2.4 Percent cells per microliter | Standard Error 1.57 |
| BMS-663068 1200 mg Q12H | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD8+, Day 8, n=9, 9, 10, 10, 10 | -0.2 Percent cells per microliter | Standard Error 1.2 |
| BMS-663068 1200 mg Q12H | Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count | Percent CD4+, Day 8, n=9, 9, 10, 10, 10 | 1.4 Percent cells per microliter | Standard Error 1.11 |
Secondary
Cmax of BMS-626529 Following QHS Dosing
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).
Time frame: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Cmax of BMS-626529 Following QHS Dosing | Day 1, n=10 | 3.85 μg/mL | Geometric Coefficient of Variation 32 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Cmax of BMS-626529 Following QHS Dosing | Day 8, PM, n=9 | 3.47 μg/mL | Geometric Coefficient of Variation 31.7 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Cmax of BMS-626529 Following QHS Dosing | Day 8, AM+PM, n=9 | 3.47 μg/mL | Geometric Coefficient of Variation 31.7 |
Secondary
Cmax of Ritonavir Following Q12H Dosing
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.
Time frame: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Cmax of Ritonavir Following Q12H Dosing | Day 8, PM, n=9,10,0 | 1.48 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 47.7 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Cmax of Ritonavir Following Q12H Dosing | Day 8, AM+PM, n=9,10,10 | 1.39 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 50.7 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Cmax of Ritonavir Following Q12H Dosing | Day 8, AM, n=9,10,10 | 1.30 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 58.3 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Cmax of Ritonavir Following Q12H Dosing | Day 1, n=10,10,10 | 0.314 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 111 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Cmax of Ritonavir Following Q12H Dosing | Day 8, AM+PM, n=9,10,10 | 0.841 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 44.9 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Cmax of Ritonavir Following Q12H Dosing | Day 1, n=10,10,10 | 0.294 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 59.6 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Cmax of Ritonavir Following Q12H Dosing | Day 8, AM, n=9,10,10 | 0.841 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 44.9 |
Secondary
Cmax of Ritonavir Following QHS Dosing
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).
Time frame: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Cmax of Ritonavir Following QHS Dosing | Day 1, n=10 | 0.257 μg/mL | Geometric Coefficient of Variation 53.8 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Cmax of Ritonavir Following QHS Dosing | Day 8, PM, n=9 | 0.628 μg/mL | Geometric Coefficient of Variation 56.4 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Cmax of Ritonavir Following QHS Dosing | Day 8, AM+PM, n=9 | 0.628 μg/mL | Geometric Coefficient of Variation 56.4 |
Secondary
Ctrough of BMS-626529 Following QHS Dosing
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).
Time frame: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Ctrough of BMS-626529 Following QHS Dosing | Day 1, n=10 | 0.699 μg/mL | Geometric Coefficient of Variation 93.4 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Ctrough of BMS-626529 Following QHS Dosing | Day 5, n=9 | 0.0705 μg/mL | Geometric Coefficient of Variation 114 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Ctrough of BMS-626529 Following QHS Dosing | Day 6, n=9 | 0.0743 μg/mL | Geometric Coefficient of Variation 97.7 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Ctrough of BMS-626529 Following QHS Dosing | Day 7, n=9 | 0.0719 μg/mL | Geometric Coefficient of Variation 166 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Ctrough of BMS-626529 Following QHS Dosing | Day 8, n=9 | 0.0546 μg/mL | Geometric Coefficient of Variation 146 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Ctrough of BMS-626529 Following QHS Dosing | Day 8, PM, n=9 | 0.0544 μg/mL | Geometric Coefficient of Variation 156 |
Secondary
Ctrough of Ritonavir Following Q12H Dosing
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).
Time frame: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Ctrough of Ritonavir Following Q12H Dosing | Day 8, PM, n=9,10,0 | 0.476 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 77.9 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Ctrough of Ritonavir Following Q12H Dosing | Day 1, n=10,10,0 | 0.131 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 98.2 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Ctrough of Ritonavir Following Q12H Dosing | Day 5, n=9,10,10 | 0.554 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 73.9 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Ctrough of Ritonavir Following Q12H Dosing | Day 6, n=9,10,10 | 0.594 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 77 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Ctrough of Ritonavir Following Q12H Dosing | Day 7, n=9,10,10 | 0.587 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 76.3 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Ctrough of Ritonavir Following Q12H Dosing | Day 8, n=9,10,10 | 0.503 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 73.2 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Ctrough of Ritonavir Following Q12H Dosing | Day 8, AM, n=9,10,10 | 0.393 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 66.3 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Ctrough of Ritonavir Following Q12H Dosing | Day 7, n=9,10,10 | 0.0860 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 79.9 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Ctrough of Ritonavir Following Q12H Dosing | Day 5, n=9,10,10 | 0.0831 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 77.8 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Ctrough of Ritonavir Following Q12H Dosing | Day 8, AM, n=9,10,10 | 0.0912 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 70.5 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Ctrough of Ritonavir Following Q12H Dosing | Day 6, n=9,10,10 | 0.0820 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 77.9 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Ctrough of Ritonavir Following Q12H Dosing | Day 8, n=9,10,10 | 0.0891 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 81.7 |
Secondary
Ctrough of Ritonavir Following QHS Dosing
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).
Time frame: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Ctrough of Ritonavir Following QHS Dosing | Day 1, n=10 | 0.157 μg/mL | Geometric Coefficient of Variation 87 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Ctrough of Ritonavir Following QHS Dosing | Day 5, n=9 | 0.107 μg/mL | Geometric Coefficient of Variation 69.4 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Ctrough of Ritonavir Following QHS Dosing | Day 6, n=9 | 0.0845 μg/mL | Geometric Coefficient of Variation 67.7 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Ctrough of Ritonavir Following QHS Dosing | Day 7, n=9 | 0.0844 μg/mL | Geometric Coefficient of Variation 65 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Ctrough of Ritonavir Following QHS Dosing | Day 8, n=9 | 0.0808 μg/mL | Geometric Coefficient of Variation 73.2 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Ctrough of Ritonavir Following QHS Dosing | Day 8, PM, n=9 | 0.0830 μg/mL | Geometric Coefficient of Variation 71.7 |
Secondary
Inhibitory Quotient (IQ) of BMS-626529 by Css,Avg and by Lowest Concentration of a Drug During Dosing Interval (Cmin) Following Q12H Dosing
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | 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 | 327 Ratio | Geometric Coefficient of Variation 454 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | 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 | 97.5 Ratio | Geometric Coefficient of Variation 382 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | 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 | 67.2 Ratio | Geometric Coefficient of Variation 543 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | 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 | 252 Ratio | Geometric Coefficient of Variation 789 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | 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 | 4.54 Ratio | Geometric Coefficient of Variation 21600 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | 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 | 15.4 Ratio | Geometric Coefficient of Variation 14900 |
Secondary
Inhibitory Quotient (IQ) of BMS-626529 by Css,Avg and by Lowest Concentration of a Drug During Dosing Interval (Cmin) Following QHS Dosing
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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
Inhibitory Quotient of BMS-626529 by Ctrough Following Q12H Dosing
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.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Inhibitory Quotient of BMS-626529 by Ctrough Following Q12H Dosing | 12.2 Ratio | Geometric Coefficient of Variation 2750 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Inhibitory Quotient of BMS-626529 by Ctrough Following Q12H Dosing | 120 Ratio | Geometric Coefficient of Variation 568 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Inhibitory Quotient of BMS-626529 by Ctrough Following Q12H Dosing | 87.3 Ratio | Geometric Coefficient of Variation 763 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Inhibitory Quotient of BMS-626529 by Ctrough Following Q12H Dosing | 4.61 Ratio | Geometric Coefficient of Variation 19000 |
Secondary
Inhibitory Quotient of BMS-626529 by Ctrough Following QHS Dosing
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.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Inhibitory Quotient of BMS-626529 by Ctrough Following QHS Dosing | 4.77 Ratio | Geometric Coefficient of Variation 1010 |
Secondary
Maximum Observed Plasma Concentration (Cmax) of BMS-626529 Following Q12H Dosing
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.
Time frame: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Maximum Observed Plasma Concentration (Cmax) of BMS-626529 Following Q12H Dosing | Day 8, AM, n=9,10,10,10 | 5.55 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 37.5 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Maximum Observed Plasma Concentration (Cmax) of BMS-626529 Following Q12H Dosing | Day 8, PM, n=9,10,10,10 | 4.60 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 29.2 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Maximum Observed Plasma Concentration (Cmax) of BMS-626529 Following Q12H Dosing | Day 8, AM+PM, n=9,10,10,10 | 5.05 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 31.7 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Maximum Observed Plasma Concentration (Cmax) of BMS-626529 Following Q12H Dosing | Day 1, n=10,10,10,10 | 3.52 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 26.6 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Maximum Observed Plasma Concentration (Cmax) of BMS-626529 Following Q12H Dosing | Day 8, PM, n=9,10,10,10 | 4.77 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 36.2 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Maximum Observed Plasma Concentration (Cmax) of BMS-626529 Following Q12H Dosing | Day 8, AM, n=9,10,10,10 | 5.10 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 57.4 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Maximum Observed Plasma Concentration (Cmax) of BMS-626529 Following Q12H Dosing | Day 8, AM+PM, n=9,10,10,10 | 4.93 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 40.1 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Maximum Observed Plasma Concentration (Cmax) of BMS-626529 Following Q12H Dosing | Day 1, n=10,10,10,10 | 4.05 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 35.8 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Maximum Observed Plasma Concentration (Cmax) of BMS-626529 Following Q12H Dosing | Day 8, AM+PM, n=9,10,10,10 | 3.39 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 15.9 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Maximum Observed Plasma Concentration (Cmax) of BMS-626529 Following Q12H Dosing | Day 8, AM, n=9,10,10,10 | 3.18 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 22 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Maximum Observed Plasma Concentration (Cmax) of BMS-626529 Following Q12H Dosing | Day 1, n=10,10,10,10 | 2.55 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 27.4 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Maximum Observed Plasma Concentration (Cmax) of BMS-626529 Following Q12H Dosing | Day 8, PM, n=9,10,10,10 | 3.61 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 27.5 |
Secondary
Number of Participants With Any Abnormality in Physical Examination
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.
Time frame: Up to 50 days
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Any Abnormality in Physical Examination | 1 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Any Abnormality in Physical Examination | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Any Abnormality in Physical Examination | 2 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Any Abnormality in Physical Examination | 1 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Any Abnormality in Physical Examination | 1 Participants |
Secondary
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
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.
Time frame: Up to 50 days
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | 0 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | 0 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | 0 Participants |
Secondary
Number of Participants With Treatment Emergent Non-serious Adverse Event (Non-SAE) and Serious AE (SAE)
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.
Time frame: Up to 50 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Treatment Emergent Non-serious Adverse Event (Non-SAE) and Serious AE (SAE) | Non-SAE | 8 Participants |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Treatment Emergent Non-serious Adverse Event (Non-SAE) and Serious AE (SAE) | SAE | 0 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Treatment Emergent Non-serious Adverse Event (Non-SAE) and Serious AE (SAE) | Non-SAE | 5 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Treatment Emergent Non-serious Adverse Event (Non-SAE) and Serious AE (SAE) | SAE | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Treatment Emergent Non-serious Adverse Event (Non-SAE) and Serious AE (SAE) | Non-SAE | 9 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Treatment Emergent Non-serious Adverse Event (Non-SAE) and Serious AE (SAE) | SAE | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Treatment Emergent Non-serious Adverse Event (Non-SAE) and Serious AE (SAE) | SAE | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Treatment Emergent Non-serious Adverse Event (Non-SAE) and Serious AE (SAE) | Non-SAE | 8 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Treatment Emergent Non-serious Adverse Event (Non-SAE) and Serious AE (SAE) | Non-SAE | 9 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Treatment Emergent Non-serious Adverse Event (Non-SAE) and Serious AE (SAE) | SAE | 0 Participants |
Secondary
Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR]
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.
Time frame: Up to 50 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | RR, Within Normal | 6 Participants |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | Temperature, Above Normal | 0 Participants |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | HR, Above Normal | 0 Participants |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | RR, Above Normal | 4 Participants |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | HR, Below Normal | 1 Participants |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | Temperature, Within Normal | 9 Participants |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | RR, Below Normal | 0 Participants |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | HR, Within Normal | 9 Participants |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | Temperature, Below Normal | 1 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | RR, Above Normal | 3 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | RR, Within Normal | 7 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | HR, Within Normal | 8 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | Temperature, Above Normal | 0 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | Temperature, Below Normal | 2 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | HR, Below Normal | 2 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | HR, Above Normal | 0 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | Temperature, Within Normal | 8 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | RR, Below Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | RR, Above Normal | 3 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | HR, Within Normal | 9 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | HR, Below Normal | 1 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | RR, Below Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | RR, Within Normal | 7 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | Temperature, Above Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | Temperature, Below Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | Temperature, Within Normal | 10 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | HR, Above Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | Temperature, Above Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | RR, Below Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | Temperature, Below Normal | 1 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | RR, Above Normal | 3 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | Temperature, Within Normal | 9 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | HR, Within Normal | 10 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | HR, Below Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | RR, Within Normal | 7 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | HR, Above Normal | 0 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | Temperature, Above Normal | 0 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | RR, Below Normal | 0 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | Temperature, Within Normal | 10 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | HR, Above Normal | 0 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | HR, Within Normal | 9 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | Temperature, Below Normal | 0 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | RR, Above Normal | 8 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | RR, Within Normal | 2 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR] | HR, Below Normal | 1 Participants |
Secondary
Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
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.
Time frame: Up to 50 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Above Normal | 0 Participants |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Below Normal | 0 Participants |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Within Normal | 10 Participants |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Above Normal | 0 Participants |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Below Normal | 0 Participants |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Within Normal | 10 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Below Normal | 0 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Within Normal | 10 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Above Normal | 3 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Within Normal | 7 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Above Normal | 0 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Below Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Above Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Below Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Above Normal | 1 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Within Normal | 9 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Below Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Within Normal | 10 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Above Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Below Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Within Normal | 10 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Within Normal | 10 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Below Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Above Normal | 0 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Below Normal | 0 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Within Normal | 9 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Below Normal | 0 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Within Normal | 10 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Above Normal | 0 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Above Normal | 1 Participants |
Secondary
Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters
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.
Time frame: Up to 50 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcF, Within Normal | 9 Participants |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcB, Below Normal | 0 Participants |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | PR interval, Below Normal | 0 Participants |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcB, Within Normal | 10 Participants |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcF, Below Normal | 0 Participants |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | PR interval, Within Normal | 10 Participants |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcF, Above Normal | 1 Participants |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcB, Above Normal | 0 Participants |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | PR interval, Above Normal | 0 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcF, Above Normal | 0 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcB, Within Normal | 9 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcB, Above Normal | 1 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcB, Below Normal | 0 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | PR interval, Within Normal | 9 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcF, Within Normal | 10 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | PR interval, Below Normal | 0 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | PR interval, Above Normal | 1 Participants |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcF, Below Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcB, Within Normal | 8 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | PR interval, Above Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | PR interval, Below Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | PR interval, Within Normal | 10 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcB, Above Normal | 2 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcB, Below Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcF, Above Normal | 1 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcF, Below Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcF, Within Normal | 9 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcB, Above Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcB, Within Normal | 10 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | PR interval, Within Normal | 10 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcF, Above Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | PR interval, Below Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcF, Within Normal | 10 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcF, Below Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | PR interval, Above Normal | 0 Participants |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcB, Below Normal | 0 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | PR interval, Above Normal | 1 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcB, Above Normal | 1 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcB, Within Normal | 9 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | PR interval, Within Normal | 9 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcB, Below Normal | 0 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcF, Within Normal | 8 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcF, Below Normal | 0 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | QTcF, Above Normal | 2 Participants |
| BMS-663068 1200 mg Q12H | Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters | PR interval, Below Normal | 0 Participants |
Secondary
Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing
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).
Time frame: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 600 mg Q12H + RTV 100 mg Q12H | 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 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing | Day 8, AM, n=9,10,10,10 | 0.951 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 88.2 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing | Day 7, n=9,10,10,10 | 1.08 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 72.9 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing | Day 6, n=9,10,10,10 | 0.839 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 49.1 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing | Day 8, n=9,10,10,10 | 0.743 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 47.1 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing | Day 8, PM, n=9,10,10,10 | 0.653 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 109 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing | Day 5, n=9,10,10,10 | 1.04 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 72.2 |
| BMS-663068 1200 mg QHS + RTV 100 mg QHS | Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing | Day 1, n=10,10,10,10 | 0.499 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 83.4 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing | Day 7, n=9,10,10,10 | 0.998 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 91.8 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing | Day 1, n=10,10,10,10 | 0.640 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 114 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing | Day 5, n=9,10,10,10 | 0.760 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 67.1 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing | Day 6, n=9,10,10,10 | 0.737 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 73.2 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing | Day 8, n=9,10,10,10 | 0.720 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 83.5 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing | Day 8, AM, n=9,10,10,10 | 0.579 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 71.5 |
| BMS-663068 1200 mg Q12H + RTV 100 mg Q12H | Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing | Day 8, PM, n=9,10,10,10 | 0.553 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 68.1 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing | Day 6, n=9,10,10,10 | 0.451 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 49.2 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing | Day 8, PM, n=9,10,10,10 | 0.487 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 47.5 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing | Day 8, AM, n=9,10,10,10 | 0.469 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 122 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing | Day 5, n=9,10,10,10 | 0.518 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 48.2 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing | Day 1, n=10,10,10,10 | 0.244 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 78.3 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing | Day 8, n=9,10,10,10 | 0.628 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 76.9 |
| BMS-663068 1200 mg Q12H + RTV 100 mg QAM | Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing | Day 7, n=9,10,10,10 | 0.542 Micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 73.5 |