A Comparison of the Bioavailability of Rifabutin With and Without Lopinavir/Ritonavir in Healthy Adult Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Abbott
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Analysis of pharmacokinetic variables will be computed for each sampling time and each parameter.
Study Overview
Brief Summary
The purpose of this study is to study the safety, tolerability and pharmacokinetics of rifabutin dosing with lopinavir/ritonavir tablets in healthy volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adult Male or Female 18-55 yrs.
- •Subject has provided written consent.
- •Subject is in general good health.
- •If female, subject is postmenopausal.
- •If female, subject is not pregnant and is not breast-feeding.
- •Subject must use birth control methods or be surgically sterile.
Exclusion Criteria
- •Subject is HAV-IgM, HBsAg or HIV Ab positive.
- •Positive screen for drugs of abuse, alcohol, or smoking.
- •Cannot be on any medication, including over the counter drugs.
- •Cannot have previous history of alcohol or drug abuse.
- •Cannot have history of any major diseases or disorders.
Arms & Interventions
A, B
Group 1 receives regimen A and B. A: Healthy volunteers, receiving one 150 mg rifabutin QD alone. B: Healthy volunteers, receiving 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID.
Intervention: lopinavir/ritonavir (Drug)
A, B
Group 1 receives regimen A and B. A: Healthy volunteers, receiving one 150 mg rifabutin QD alone. B: Healthy volunteers, receiving 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID.
Intervention: rifabutin (Drug)
C
Group 2 receives regimen C. C: 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID.
Intervention: lopinavir/ritonavir (Drug)
C
Group 2 receives regimen C. C: 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID.
Intervention: rifabutin (Drug)
Outcomes
Primary Outcomes
Analysis of pharmacokinetic variables will be computed for each sampling time and each parameter.
Time Frame: Approximately 0.5 - 1 month
Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.
Time Frame: Approximately 0.5 - 1 month
Secondary Outcomes
No secondary outcomes reported