NCT02108639

Brief Summary

Assess the effect of renal function on the blood levels of DCV, ASV, BMS-791325.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

4 active sites

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
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 10, 2014

Status Verified

June 1, 2014

Enrollment Period

2 months

First QC Date

April 7, 2014

Last Update Submit

July 9, 2014

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (2)

  • Maximum observed plasma concentration (Cmax) for DCV, ASV, BMS-791325 and BMS-794712

    For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12

  • Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) for DCV, ASV, BMS-791325 and BMS-794712

    For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12

Secondary Outcomes (16)

  • Concentration at 12 hours (C12) for (DCV, ASV, BMS-791325) and BMS-948158

    For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  • Time of maximum observed concentration (Tmax) for (DCV, ASV, BMS-791325) and BMS-948158

    For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  • Apparent total body clearance (CLT/F) for (DCV, ASV and BMS-791325 only)

    For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  • Trough observed plasma concentration (Ctrough) for (DCV, ASV, BMS-791325), BMS-794712 and BMS-948158

    For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  • Cmax fraction unbound (Cmaxfu) for (DCV, ASV, BMS-791325), BMS-794712 and BMS-948158

    For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  • +11 more secondary outcomes

Study Arms (1)

DCV 3DAA FDC + BMS-791325

EXPERIMENTAL

Group A to D: DCV 3DAA FDC + BMS-791325 oral tablets on specific days Group E: DCV 3DAA FDC + BMS-791325 oral tablets on specific days

Drug: DCV 3DAA FDCDrug: BMS-791325

Interventions

DCV 3DAA FDCDRUG
Also known as: Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325
DCV 3DAA FDC + BMS-791325
BMS-791325DRUG
DCV 3DAA FDC + BMS-791325

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects in Group A must be in good health and have normal renal function
  • Subjects in Groups B-E may have clinical, Electrocardiogram (ECG) and laboratory findings consistent with their degree of renal dysfunction
  • Women of childbearing potential (WOCBP) and male participants must agree to follow the required contraceptive methods

You may not qualify if:

  • Subjects in Group A must not have any significant acute or chronic illnesses
  • Subjects in Groups B-E must not have uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, and/or neurological disease within 6 months of screening
  • Subjects in Groups B-E may not have evidence of rapidly deteriorating renal function, defined as a screening creatinine clearance (CLcr) which has decreased from a previous CLcr by 50% within the last 3 months
  • Prior exposure to DCV, ASV or BMS-791325 within 3 months prior to study drug administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Clinical Pharmacology Of Miami Inc.

Miami, Florida, 33014, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Davita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

New Orleans Center For Clinical Research - Knoxville

Knoxville, Tennessee, 37920, United States

Location

Related Links

MeSH Terms

Conditions

Hepatitis C

Interventions

asunaprevir8-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-carboxamide

Condition Hierarchy (Ancestors)

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

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 7, 2014

First Posted

April 9, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 10, 2014

Record last verified: 2014-06

Locations

US(4)