NCT02104843

Brief Summary

The primary purpose is to assess the effect of Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 combination therapy on the exposure of Rosuvastatin.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_1

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

April 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

July 18, 2014

Status Verified

July 1, 2014

Enrollment Period

1 month

First QC Date

April 2, 2014

Last Update Submit

July 17, 2014

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (3)

  • Maximum observed concentration (Cmax) of Rosuvastatin

    Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)

  • Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of Rosuvastatin

    Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)

  • Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin

    Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)

Secondary Outcomes (10)

  • Time of maximum observed concentration (Tmax) of Rosuvastatin

    Days 1 and 15 (predose through 96 hours)

  • Half life (T-HALF) of Rosuvastatin

    Days 1 and 15 (predose through 96 hours)

  • Apparent total body clearance (CLT/F) of Rosuvastatin

    Days 1 and 15 (predose through 96 hours)

  • Maximum observed concentration (Cmax) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712

    Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose

  • Trough observed plasma concentration (predose) (Ctrough) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712

    Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose

  • +5 more secondary outcomes

Study Arms (1)

Arm 1: DCV/ASV/BMS-791325 FDC + BMS-791325 + Rosuvastatin

EXPERIMENTAL

Treatment A: Rosuvastatin tablet orally on specified days Treatment B: Daclatasvir, Asunaprevir and BMS-791325 Fixed dose combination (FDC) + BMS-791325 tablet orally on specified days Treatment C: Daclatasvir, Asunaprevir and BMS-791325 FDC + BMS-791325 + Rosuvastatin tablet orally on specified days

Drug: Daclatasvir, Asunaprevir and BMS-791325 FDCDrug: BMS-791325Drug: Rosuvastatin

Interventions

Daclatasvir, Asunaprevir and BMS-791325 FDCDRUG
Arm 1: DCV/ASV/BMS-791325 FDC + BMS-791325 + Rosuvastatin
BMS-791325DRUG
Arm 1: DCV/ASV/BMS-791325 FDC + BMS-791325 + Rosuvastatin
RosuvastatinDRUG
Also known as: Crestor®
Arm 1: DCV/ASV/BMS-791325 FDC + BMS-791325 + Rosuvastatin

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects with no clinically significant deviations from normal in medical history, physical exam findings, 12 lead ECG measurements and clinical laboratory tests
  • Females must be of non-childbearing potential

You may not qualify if:

  • Women of childbearing potential
  • Any significant acute or chronic medical condition
  • Inability to tolerate oral medications
  • Inability to be venipunctured and/or tolerate venous access
  • Abnormal liver function tests
  • Current or recent (within 3 months of dosing) gastrointestinal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C

Interventions

daclatasvirasunaprevir8-cyclohexyl-N-((dimethylamino)sulfonyl)-1,1a,2,12b-tetrahydro-11-methoxy-1a-((3-methyl-3,8-diazabicyclo(3.2.1)oct-8-yl)carbonyl)cycloprop(d)indolo(2,1-a)(2)benzazepine-5-carboxamideRosuvastatin Calcium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bristol Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2014

First Posted

April 4, 2014

Study Start

April 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

July 18, 2014

Record last verified: 2014-07