Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rifabutin · 1 trial · 1 indication
AUC24avg is AUC(0-24 hour) following dosing on Day 10 for RIB 150mg once daily (QD); AUC24avg is the area under the plasma concentration-time curve in 1 dosing interval (AUC\[TAU\]) divided by the number of days over the sampling duration for ATV/RTV 300/100 mg QD+RIB 150 mg twice weekly, i.e. AUC(TAU)/7.
Cmax was derived from plasma concentration versus time for RIB and was recorded directly from experimental observations for each treatment period.
Cmin was derived from plasma concentration versus time for RIB.
AUC24avg is AUC(0-24 hour) following dosing on Day 10 for RIB 150 mg QD; AUC24avg is the area under the plasma concentration-time curve in 1 dosing interval (AUC\[TAU\]) divided by the number of days over the sampling duration for ATV/RTV 300/100 mg QD+RIB 150 mg twice weekly, i.e. AUC(TAU)/7
Cmax was derived from the plasma concentration versus time for 25-O-Desacetyl-RIB (a metabolite of RIB) and was recorded directly from experimental observations for each treatment period.
Cmin was derived from plasma concentration versus time for 25-O-Desacetyl-RIB.
AUCtot represents the total free RIB plus 25-O-Desacetyl-RIB output. It is calculated as: AUCtot (micromolar\[µM\]\*h) = AUC24avg(RIB)(ng\*h/mL)/847.016 (g/mole) + AUC24avg(25-O-Desacetyl-RIB)(ng\*h/mL)/804.979(g/mole). The 300 mg RIB arm represents an extrapolation from the 150 mg RIB group.
| Arm | Type | Description |
|---|---|---|
| A | ACTIVE_COMPARATOR | - |
| B | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Rifabutin | DRUG | Capsule, Oral, 150 mg, once daily, 11 Days |
| Rifabutin + Atazanavir + Ritonavir | DRUG | Capsules, Oral, 18 Days Rifabutin (150 mg, 2x/wk) Atazanavir (300 mg, once daily) Ritonavir (100 mg, once daily) |
Inclusion Criteria: * Healthy male and female subjects between the ages of 18 to 50 years old with a body mass index (BMI) of 18 to 32 kg/m² * Prior to enrollment, subjects must have physical and laboratory test findings within the normal limits, and women of childbearing potential (WOCBP) must hav...
Rifabutin is a small molecule being developed for use in antivirals and HIV treatment. It is currently in Phase 1 clinical development for infectious disease indications. The drug is being studied for its potential role in managing HIV-related conditions, though it remains investigational and is not yet approved.
Rifabutin is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical research on this small molecule for infectious disease applications, specifically in the area of antivirals and HIV treatment.
Rifabutin is currently in Phase 1 clinical development. It is an investigational drug being studied for infectious disease indications, particularly in the field of antivirals and HIV. The drug has completed one Phase 1 trial and is not yet approved for any use.
Rifabutin has been studied in one completed clinical trial, NCT00646776, titled "Drug Interaction Study." This Phase 1 trial enrolled 85 participants in the United States, including healthy volunteers, and was active-controlled but not double-blinded. The study focused on antiviral and HIV-related conditions.
Rifabutin is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for infectious disease indications, specifically antivirals and HIV. The drug has completed one clinical trial but remains in early-stage development and has not received regulatory approval.