NCT02159352

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2014

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

November 30, 2015

Completed
Last Updated

November 30, 2015

Status Verified

October 1, 2015

Enrollment Period

1 month

First QC Date

June 6, 2014

Results QC Date

August 21, 2015

Last Update Submit

October 29, 2015

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (2)

  • Maximum Observed Plasma Concentration (Cmax) for Daclatasvir

    Cmax was obtained from concentration-time plot using a noncompartmental method and a validated pharmacokinetic analysis program.

    Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)

  • Area Under the Concentration-Time Curve in 1 Dosing Interval (AUC[TAU]) for Daclatasvir

    AUC(TAU) was the area under the curve from time zero to end of dosing interval. AUC(TAU) was obtained from concentration-time plot of daclatasvir using noncompartmental method and a validated pharmacokinetic analysis program.

    Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)

Secondary Outcomes (9)

  • Time of Maximum Observed Plasma Concentration (Tmax) of Daclatasvir

    Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)

  • Plasma Concentration Observed at 24 Hours Postdose (C24) of Daclatasvir

    Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)

  • Dose-normalized Maximum Observed Plasma Concentration (Cmax/D) and Dose-normalized Plasma Concentration Observed at 24 Hours Postdose (C24/D) of Daclatasvir

    Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)

  • Dose-normalized Area Under the Concentration-Time Curve in 1 Dosing Interval (AUC[TAU]/D) of Daclatasvir

    Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)

  • Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) and Who Died

    From start of study treatment (Day 1) to study discharge for AEs (up to 15 days); Day 1 to 30 days after last dose of study treatment for SAEs (up to 44 days)

  • +4 more secondary outcomes

Study Arms (2)

Group 1: Daclatasvir and Darunavir/Ritonavir

EXPERIMENTAL

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

Drug: DaclatasvirDrug: DarunavirDrug: Ritonavir

Group 2: Daclatasvir and Lopinavir/Ritonavir

EXPERIMENTAL

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

Drug: DaclatasvirDrug: RitonavirDrug: Lopinavir/Ritonavir

Interventions

DaclatasvirDRUG
Also known as: BMS-790052
Group 1: Daclatasvir and Darunavir/RitonavirGroup 2: Daclatasvir and Lopinavir/Ritonavir
DarunavirDRUG
Also known as: Prezista
Group 1: Daclatasvir and Darunavir/Ritonavir
RitonavirDRUG
Also known as: Norvir
Group 1: Daclatasvir and Darunavir/RitonavirGroup 2: Daclatasvir and Lopinavir/Ritonavir
Lopinavir/RitonavirDRUG
Group 2: Daclatasvir and Lopinavir/Ritonavir

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthcare Discoveries, Llc D/B/A Icon Development Solutions

San Antonio, Texas, 78209, United States

Location

Related Links

MeSH Terms

Conditions

Hepatitis C

Interventions

daclatasvirDarunavirRitonavirLopinavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsCarbamatesAcids, AcyclicCarboxylic AcidsSulfonesSulfur CompoundsFuransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesAzolesPyrimidinonesPyrimidines

Results Point of Contact

Title
Bristol-Myers Squibb Study Director
Organization
Bristol-Myers Squibb
Clinical.Trials@bms.com

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2014

First Posted

June 9, 2014

Study Start

June 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

November 30, 2015

Results First Posted

November 30, 2015

Record last verified: 2015-10

Locations

US(1)