Phase 1
Completed N=28
Study Assessing the Effects of Darunavir/Ritonavir or Lopinavir/Ritonavir on the Pharmacokinetics of Daclatasvir in Healthy Participants
Source: ClinicalTrials.gov NCT02159352 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) for Daclatasvir — 1335; 493; 1412; 476 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) for Daclatasvir |
1335; 493; 1412; 476 | — |
| PRIMARY Area Under the Concentration-Time Curve in 1 Dosing Interval (AUC[TAU]) for Daclatasvir |
12677; 8295; 13799; 7855 | — |
| SECONDARY Time of Maximum Observed Plasma Concentration (Tmax) of Daclatasvir |
2.00; 3.00; 2.00; 2.00 | — |
| SECONDARY Plasma Concentration Observed at 24 Hours Postdose (C24) of Daclatasvir |
225; 250; 225; 280 | — |
| SECONDARY Dose-normalized Maximum Observed Plasma Concentration (Cmax/D) and Dose-normalized Plasma Concentration Observed at 24 Hours Postdose (C24/D) of Daclatasvir |
22.2; 16.4; 23.5; 15.9; 3.75; 8.34 | — |
| SECONDARY Dose-normalized Area Under the Concentration-Time Curve in 1 Dosing Interval (AUC[TAU]/D) of Daclatasvir |
211; 276; 230; 262 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) and Who Died |
0; 0; 0; 0; 0; 3 | — |
| SECONDARY Number of Participants With Abnormalities in Vital Sign Measurements |
3; 2 | — |
| SECONDARY Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings |
2; 4; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Marked Abnormalities in Hematology Laboratory Test Results |
1; 0; 0; 0; 0; 1 | — |
| SECONDARY Number of Participants With Abnormalities in Urinalysis and Other Chemistry Testing Results |
2; 1; 1; 0; 1; 1 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02159352). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.