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Atazanavir Sulphate + Ritonavir

Phase 1

HIV Infections | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Apr 8, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials3
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00362726Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate RosiglitazonePHASE1 COMPLETED 14 — — Sep 1, 2006Nov 1, 2006Apr 8, 20111 United States
NCT00357188Dose Finding Confirmation of Atazanavir With Ritonavir and Efavirenz (ATV/RTV + EFV) in Healthy SubjectsPHASE1 COMPLETED 22 — — Jul 1, 2006Sep 1, 2006Apr 8, 20111 United States
NCT00357721Atazanavir Twice DailyPHASE1 COMPLETED 18 — — Jun 1, 2006Sep 1, 2006Apr 6, 20111 United States
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Study Endpoints
Primary Endpoints
To assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of Rosiglitazone in healthy subjects.
To assess the comparability of atazanavir exposure when dosed in the evening as atazanavir 400 mg with ritonavir 100 mg and with efavirenz 600 mg relative to ATV 300 mg and RTV 100 mg alone in healthy subjects
Assess the pharmacokinetics (PK) of atazanavir administered twice-daily (BID) relative to historical data from atazanavir/ritonavir 300/100 mg, given once-daily.
Secondary Endpoints
To assess the safety and tolerability of Rosiglitazone and Atazanavir coadministration with and without Ritonavir.
To explore the relationship between Atazanavir exposure, CYP2C8 genotype and the pharmacokinetics of Rosiglitazone exposure
To assess the PK of EFV when coadministered with ATV 400 mg and RTV 100 mg in the evening
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
AACTIVE_COMPARATOR -
BACTIVE_COMPARATOR -
CACTIVE_COMPARATOR -
DACTIVE_COMPARATOR -
EACTIVE_COMPARATOR -
A1ACTIVE_COMPARATOR -
A2ACTIVE_COMPARATOR -
A3ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Rosiglitazone maleateDRUGTablets, Oral, RGZ 4 mg, once daily, 1 day.
Atazanavir SulphateDRUGCapsules, Oral, ATV 400 mg, once daily, 5 days.
Atazanavir Sulphate + Rosiglitazone maleateDRUGCapsule, Oral, ATV 400 mg + RGZ 4 mg, once daily, 1 day.
Atazanavir Sulphate + RitonavirDRUGCapsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 14 days.
Atazanavir Sulphate + Ritonavir + Rosiglitazone maleateDRUGCapsules/Tablets, Oral, ATV 300 mg + RTV 100 mg + RGZ 4 mg, once daily, 1 day.
Atazanavir Sulphate + Ritonavir + EfavirenzDRUGCapsules/Tablets, oral, ATV 400 mg + RTV 100 mg + EFV 600 mg, once daily, 14 days.
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2

Countries:United States
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Competitive Landscape -Bacterial Infections 62 trials
CompanyTickerTrialsLead PhaseDrugs
Pfizer Inc.PFE5PHASE3VLA15, ATM-AVI, BAT, Part A: ATM-AVI Single Dose, Cohorts 1-4, PG4 vaccine in Buffer 1 with low dose PA-001
Sanofi SA Sponsored ADRSNY2PHASE3PCV21, 20vPCV
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
GSK plc Sponsored ADRGSK4PHASE2MenABCWY vaccine, iNTS-GMMA Dose C, iNTS-GMMA Dose B, iNTS-GMMA Dose A, MenACWY
Zai Lab Ltd. Sponsored ADRZLAB1PHASE3Omadacycline, Moxifloxacin
CorMedix Inc.CRMD2PHASE3catheter lock, Heparin, Vabomere
Sinovac Biotech Ltd.SVA4PHASE3Sinovac PCV13, Prevnar, Sinovac PCV24, high-dose Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine
Novartis AG Sponsored ADRNVS1PHASE2Cryptosporidium parvum oocysts, EDI048
Innoviva, Inc.INVA3PHASE2Eravacycline /kg, Sulbactam /kg -Durlobactam /kg
BiomX LtdPHGE1PHASE2BX004
Merck & Co., Inc.MRK2PHASE1V118C, PCV20
AstraZeneca PLCAZN1PHASE1AZD7760
BioNTech SE Sponsored ADRBNTX1PHASE1BNT163
ICON PlcICLR1PHASE2AV7909 Full Dose, AV7909 Half Dose
60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
Moderna, Inc.MRNA1PHASE2mRNA-1982
Tarsus Pharmaceuticals, Inc.TARS1PHASE2TP-05 Low Dose
AN2 Therapeutics, Inc.ANTX1PHASE2Epetraborole
Emergent BioSolutions Inc.EBS4 — AIGIV, CYFENDUS, Collection of samples
Abbott LaboratoriesABT1NAUndisclosed
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