Study Assessing the Effects of Darunavir/Ritonavir or Lopinavir/Ritonavir on the Pharmacokinetics of Daclatasvir in Healthy Participants

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: Daclatasvir; Drug: Ritonavir; Drug: Darunavir; Drug: Lopinavir/Ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02159352

AI444-093

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.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

Trial design

49 participants in 2 patient groups

Group 1: Daclatasvir and Darunavir/Ritonavir

Experimental group

Description:

Treatment A: Daclatasvir oral tablet on specific days Treatment B: Daclatasvir tablet and Darunavir Tablet/Ritonavir capsule orally on specific days

Treatment:

Drug: Darunavir

Drug: Ritonavir

Drug: Daclatasvir

Group 2: Daclatasvir and Lopinavir/Ritonavir

Experimental group

Description:

Treatment C: Daclatasvir oral tablet on specific days Treatment D: Daclatasvir tablet and Lopinavir/Ritonavir tablet orally on specific days

Treatment:

Drug: Ritonavir

Drug: Lopinavir/Ritonavir

Drug: Daclatasvir