NCT02095860

Brief Summary

The purpose of this study is to assess the effect of a high fat meal and light meal on the blood levels of Daclatasvir, Asunaprevir and BMS-791325 after administration of the 3 drugs as a fixed-dose combination in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 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

First Submitted

Initial submission to the registry

March 21, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1 month 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

October 10, 2014

Status Verified

October 1, 2014

Enrollment Period

1 month

First QC Date

March 21, 2014

Last Update Submit

October 9, 2014

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (2)

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

    Day 1 to Day 13

  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of DCV, ASV and BMS-791325

    Day 1 to Day 13

Secondary Outcomes (12)

  • Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for DCV, ASV and BMS-791325

    Day 1 to Day 13

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

    Day 1 to Day 13

  • Terminal plasma half life (T-HALF) for DCV, ASV and BMS-791325

    Day 1 to Day 13

  • AUC(0-T) for BMS-794712

    Day 1 to Day 13

  • AUC(INF) for BMS-794712

    Day 1 to Day 13

  • +7 more secondary outcomes

Study Arms (3)

Treatment A: DCV 3DAA FDC fasted state

EXPERIMENTAL

DCV 3 Direct Acting Antiviral (DAA) Fixed Dose Combination (FDC) tablet by mouth once on specified days in fasted state

Drug: DCV 3DAA FDC

Treatment B: DCV 3DAA FDC with high-fat meal

EXPERIMENTAL

DCV 3DAA FDC tablet by mouth once on specified days with high-fat meal

Drug: DCV 3DAA FDC

Treatment C: DCV 3DAA FDC with light meal

EXPERIMENTAL

DCV 3DAA FDC tablet by mouth once on specified days with light meal

Drug: DCV 3DAA FDC

Interventions

DCV 3DAA FDCDRUG

Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325

Treatment A: DCV 3DAA FDC fasted stateTreatment B: DCV 3DAA FDC with high-fat mealTreatment C: DCV 3DAA FDC with light meal

Eligibility Criteria

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

You may qualify if:

  • Healthy male and female subjects ages 18 to 49 years, inclusive.
  • Women of childbearing potential must be using an acceptable method of contraception for at least 4 weeks prior to study drug administration.

You may not qualify if:

  • Any significant acute or chronic medical illness
  • Current or recent (within 3 months of study drug administration) gastrointestinal disease
  • Any gastrointestinal surgery that could impact upon the absorption of study drug, including cholecystectomy
  • History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease
  • Use of tobacco-containing or nicotine-containing products
  • Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration, confirmed by repeat:
  • PR ≥210 msec
  • QRS ≥120 msec
  • QT ≥500 msec
  • QTcF ≥450 msec
  • Any of the following laboratory results outside of the ranges specified below prior to study drug administration, confirmed by repeat:
  • Alanine aminotransferase (ALT) \>Upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) \>ULN
  • Total bilirubin (TBILI) \>ULN
  • Creatinine \>ULN

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

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
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2014

First Posted

March 26, 2014

Study Start

April 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

October 10, 2014

Record last verified: 2014-10

Locations

US(1)