1. History or presence of allergy to the study drugs or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation 
2. Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance 
3. History or diagnosis of any significant medical conditions: Including but not limited to gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematological, psychiatric, neurological, oncological or hormonal disorders 
4. Known elevated liver enzymes in past clinical trials with any compound (experimental or marketed) 
5. Clinically relevant laboratory abnormalities (e.g. Hgb<11g/dL, Hct<30g/dL, total cholesterol >240mg/dL, triglycerides >500mg/dL, fasting glucose >130mg/dL, liver function tests >2.5x upper limit of normal, baseline international normalized ratio >1.2) 
6. History of evidence of clinically significant hepatic, cardiac, pulmonary, endocrine, immunological, gastrointestinal, hematological, vascular or collagen disease 
7. History of alcohol abuse or use of any illicit drugs 
8. Unable to abstain from more than one beer or alcohol equivalent per day for the duration of the study 
9. Use of tobacco products and/or history of smoking within the past 2 months 
10. Pregnant or breast feeding 
11. Sexually active women of childbearing age who do not use an acceptable barrier method of birth control 
12. Hypersensitivity to caffeine, warfarin, vitamin K, omeprazole, dextromethorphan, midazolam, tipranavir, ritonavir or their excipients 
13. Concomitant treatment with other experimental compounds 
14. Concomitant administration of any prescription or over the counter medications known to alter P450 enzyme or P-gp activity 
15. Concomitant administration of any prescription or over the counter medications known to be highly dependent on P450 or P-gp for clearance for which elevated plasma concentrations are known to be associated with serious toxicity 
16. Concomitant administration of any food product known to alter P450 enzyme or P-gp activity such as grapefruit juice, Seville oranges 
17. Concomitant administration of any drug that could affect bleeding (e.g., aspirin, clopidogrel, ticlopidine, warfarin, heparin, low-molecular weight heparin) 
18. Concomitant administration of oral contraceptives (may be included with 7-day washout period) 
19. Concomitant administration of any herbal medications 
20. Inadequate venous access 
21. Renal or hepatic insufficiency 
22. Clinically unacceptable result at the screening physical examination 
23. Use of investigational medications within 30 days before study entry 
24. HIV-positive 
25. Body Mass Index (BMI) > 30 kg/m²       
    

NCT02243553_exc_T26
Measurement
Body Mass Index (BMI)
NCT02243553_exc_T27
Value
> 30 kg/m²
NCT02243553_exc_T28
Measurement
HIV
NCT02243553_exc_T29
Value
positive
NCT02243553_exc_T30
Drug
investigational medications
NCT02243553_exc_T32
Temporal
within 30 days before study entry
NCT02243553_exc_T33
Reference_point
study entry
NCT02243553_exc_T34
Condition
Clinically unacceptable result
NCT02243553_exc_T35
Temporal
at the screening physical examination
NCT02243553_exc_T36
Reference_point
the screening physical examination
NCT02243553_exc_T37
Procedure
physical examination
NCT02243553_exc_T38
Qualifier
Clinically unacceptable
NCT02243553_exc_T41
Condition
hepatic insufficiency
NCT02243553_exc_T42
Condition
Renal insufficiency
NCT02243553_exc_T43
Device
venous access
NCT02243553_exc_T44
Qualifier
Inadequate
NCT02243553_exc_T45
Drug
herbal medications
NCT02243553_exc_T46
Temporal
Concomitant
NCT02243553_exc_T47
Drug
oral contraceptives
NCT02243553_exc_T48
Temporal
Concomitant
NCT02243553_exc_T50
Drug
drug that could affect bleeding
NCT02243553_exc_T52
Drug
aspirin
NCT02243553_exc_T53
Drug
clopidogrel
NCT02243553_exc_T54
Drug
ticlopidine
NCT02243553_exc_T55
Drug
warfarin
NCT02243553_exc_T56
Drug
heparin
NCT02243553_exc_T57
Drug
low-molecular weight heparin
NCT02243553_exc_T58
Scope
aspirin, clopidogrel, ticlopidine, warfarin, heparin, low-molecular weight heparin
NCT02243553_exc_T59
Temporal
Concomitant
NCT02243553_exc_T60
Drug
food product known to alter P450 enzyme activity
NCT02243553_exc_T61
Drug
food product known to alter P-gp activity
NCT02243553_exc_T62
Drug
grapefruit juice
NCT02243553_exc_T63
Drug
Seville oranges
NCT02243553_exc_T64
Scope
grapefruit juice, Seville oranges
NCT02243553_exc_T65
Scope
food product known to alter P450 enzyme or P-gp activity
NCT02243553_exc_T66
Temporal
Concomitant
NCT02243553_exc_T67
Drug
medications known to be highly dependent on P450 for clearance
NCT02243553_exc_T68
Drug
medications known to be highly dependent on P-gp for clearance
NCT02243553_exc_T69
Measurement
plasma concentrations
NCT02243553_exc_T70
Value
elevated
NCT02243553_exc_T71
Condition
toxicity
NCT02243553_exc_T72
Scope
medications known to be highly dependent on P450 or P-gp for clearance
NCT02243553_exc_T73
Qualifier
serious
NCT02243553_exc_T74
Scope
elevated plasma concentrations
NCT02243553_exc_T75
Drug
medications known to alter P450 enzyme activity
NCT02243553_exc_T76
Drug
medications known to alter P-gp activity
NCT02243553_exc_T80
Temporal
Concomitant
NCT02243553_exc_T81
Scope
medications known to alter P450 enzyme or P-gp activity
NCT02243553_exc_T82
Temporal
Concomitant
NCT02243553_exc_T83
Drug
experimental compounds
NCT02243553_exc_T84
Drug
caffeine
NCT02243553_exc_T85
Drug
warfarin
NCT02243553_exc_T86
Drug
vitamin K
NCT02243553_exc_T87
Drug
omeprazole
NCT02243553_exc_T88
Drug
dextromethorphan
NCT02243553_exc_T89
Drug
midazolam
NCT02243553_exc_T90
Drug
tipranavir
NCT02243553_exc_T91
Drug
ritonavir
NCT02243553_exc_T92
Condition
Hypersensitivity
NCT02243553_exc_T93
Scope
caffeine, warfarin, vitamin K, omeprazole, dextromethorphan, midazolam, tipranavir, ritonavir
NCT02243553_exc_T94
Person
women
NCT02243553_exc_T95
Condition
Sexually active
NCT02243553_exc_T96
Value
childbearing
NCT02243553_exc_T97
Person
age
NCT02243553_exc_T98
Device
barrier method of birth control
NCT02243553_exc_T99
Qualifier
acceptable
NCT02243553_exc_T100
Negation
not
NCT02243553_exc_T101
Condition
Pregnant
NCT02243553_exc_T102
Observation
breast feeding
NCT02243553_exc_T103
Drug
tobacco products
NCT02243553_exc_T105
Observation
smoking
NCT02243553_exc_T106
Temporal
within the past 2 months
NCT02243553_exc_T104
Observation
history
NCT02243553_exc_T108
Condition
alcohol abuse
NCT02243553_exc_T109
Condition
use of illicit drugs
NCT02243553_exc_T110
Condition
collagen disease
NCT02243553_exc_T111
Condition
vascular disease
NCT02243553_exc_T112
Condition
hematological disease
NCT02243553_exc_T113
Condition
gastrointestinal disease
NCT02243553_exc_T114
Condition
immunological disease
NCT02243553_exc_T115
Condition
endocrine disease
NCT02243553_exc_T116
Condition
pulmonary disease
NCT02243553_exc_T117
Condition
cardiac disease
NCT02243553_exc_T118
Condition
hepatic disease
NCT02243553_exc_T120
Scope
hepatic, cardiac, pulmonary, endocrine, immunological, gastrointestinal, hematological, vascular or collagen disease
NCT02243553_exc_T121
Qualifier
clinically significant
NCT02243553_exc_T122
Observation
History
NCT02243553_exc_T123
Qualifier
Clinically relevant
NCT02243553_exc_T125
Condition
laboratory abnormalities
NCT02243553_exc_T126
Measurement
Hgb
NCT02243553_exc_T127
Value
<11g/dL
NCT02243553_exc_T128
Measurement
Hct
NCT02243553_exc_T129
Measurement
total cholesterol
NCT02243553_exc_T130
Measurement
triglycerides
NCT02243553_exc_T131
Measurement
fasting glucose
NCT02243553_exc_T132
Measurement
liver function tests
NCT02243553_exc_T133
Value
>2.5x upper limit of normal
NCT02243553_exc_T134
Measurement
international normalized ratio
NCT02243553_exc_T135
Value
>1.2
NCT02243553_exc_T136
Temporal
baseline
NCT02243553_exc_T137
Value
>130mg/dL
NCT02243553_exc_T138
Value
>500mg/dL
NCT02243553_exc_T139
Value
>240mg/dL
NCT02243553_exc_T140
Value
<30g/dL
NCT02243553_exc_T141
Scope
Hgb<11g/dL, Hct<30g/dL, total cholesterol >240mg/dL, triglycerides >500mg/dL, fasting glucose >130mg/dL, liver function tests >2.5x upper limit of normal, baseline international normalized ratio >1.2
NCT02243553_exc_T142
Scope
Clinically relevant laboratory abnormalities
NCT02243553_exc_T143
Measurement
liver enzymes
NCT02243553_exc_T144
Value
elevated
NCT02243553_exc_T147
Condition
medical conditions
NCT02243553_exc_T150
Condition
hormonal disorders
NCT02243553_exc_T151
Condition
oncological disorders
NCT02243553_exc_T152
Condition
neurological disorders
NCT02243553_exc_T153
Condition
psychiatric disorders
NCT02243553_exc_T154
Condition
hematological disorders
NCT02243553_exc_T155
Condition
immunologic disorders
NCT02243553_exc_T156
Condition
metabolic disorders
NCT02243553_exc_T157
Condition
cardiovascular disorders
NCT02243553_exc_T158
Condition
respiratory disorders
NCT02243553_exc_T159
Condition
renal disorders
NCT02243553_exc_T160
Condition
hepatic disorders
NCT02243553_exc_T161
Condition
gastrointestinal disorders
NCT02243553_exc_T162
Scope
gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematological, psychiatric, neurological, oncological or hormonal disorders
NCT02243553_exc_T163
Qualifier
significant
NCT02243553_exc_T167
Condition
allergy
NCT02243553_exc_T168
Drug
study drugs