Overview
Study Assessing the Effects of Darunavir/Ritonavir or Lopinavir/Ritonavir on the Pharmacokinetics of Daclatasvir in Healthy Participants
Status:
Completed
Completed
Trial end date:
2014-07-01
2014-07-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to determine whether multiple doses of darunavir/ritonavir or lopinavir/ritonavir affect the pharmacokinetics of daclatasvir in healthy participants.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Bristol-Myers SquibbTreatments:
Darunavir
Lopinavir
Ritonavir
Criteria
For more information regarding BMS clinical trial participation, please visitwww.BMSStudyConnect.com
Key Inclusion Criteria:
- Healthy male and female participants, aged 18 to 49, as determined by medical history,
physical examination, 12 lead electrocardiogram, vital signs, and clinical laboratory
evaluations
Key Exclusion Criteria:
- Any significant acute or chronic medical illness; donation of blood to a blood bank or
in a clinical study (except a screening visit) within 4 weeks of study drug
administration (within 2 weeks for plasma only); or blood screen findings positive for
hepatitis C antibody, hepatitis B surface antigen, or HIV-1 and HIV-2 antibodies