NCT02175602

Brief Summary

The purpose of this study is to assess the effect of Daclatasvir, Asunaprevir, and BMS-791325 on the pharmacokinetics of selective serotonin reuptake inhibitors.

Trial Health

100
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

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
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Last Updated

February 10, 2015

Status Verified

February 1, 2015

Enrollment Period

2 months

First QC Date

June 24, 2014

Last Update Submit

February 9, 2015

Conditions

Hepatitis C Infection

Outcome Measures

Primary Outcomes (2)

  • Serial blood samples for plasma SSRI (selective serotonin reuptake inhibitor) of escitalopram or sertraline

    Before dosing (0 hour) through 24 hours after SSRI administration on day 7 and day 29

  • Serial blood samples for determination of plasma concentrations of DCV (daclatasvir), ASV (asunaprevir), BMS-791325, and the metabolite BMS-794712

    Before dosing (0 hour) through 12 hours after SSRI administration on day 22 and day 29

Secondary Outcomes (1)

  • Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.

    Two to three months

Study Arms (2)

Cohort 2

EXPERIMENTAL

Sertraline (50 milligrams each morning) day 1-7, DCV 3DAA FDC + 75 mg BMS-791325 twice daily days 13 to 22, DCV 3DAA FDC + 75 mg BMS-791325 twice daily + Sertraline (50 milligrams each morning) days 23-29

Drug: SertralineDrug: DCV 3DAA FDCDrug: BMS-791325

Cohort 1

EXPERIMENTAL

Escitalopram (10 milligrams each morning) day 1-7, DCV 3DAA FDC + 75 mg BMS-791325 twice daily days 13 to 22, DCV 3DAA FDC + 75 mg BMS-791325 twice daily + Escitalopram (10 milligrams each morning) days 23-29

Drug: EscitalopramDrug: DCV 3DAA FDCDrug: BMS-791325

Interventions

EscitalopramDRUG

10 milligrams administered each morning

Also known as: Lexapro
Cohort 1
SertralineDRUG

50 milligrams administered each morning

Also known as: Zoloft
Cohort 2
DCV 3DAA FDCDRUG

Fixed dose combination (daclatasvir \[DCV\] 30 milligrams, asunaprevir \[ASV\] 200 milligrams, and BMS-791325 75 milligrams) one tablet administered twice daily

Cohort 1Cohort 2
BMS-791325DRUG

75 milligrams single-agent film coated oral tablet administered twice daily

Cohort 1Cohort 2

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Signed Informed Consent Form
  • a) Signed written informed consent must be obtained from the subjects in accordance with requirements of the study center's IRB or IEC before the initiation of any protocol-required procedures.
  • Target Population
  • a) Healthy subjects as determined by no clinically significant deviation from normal in medical history, psychiatric history, physical examination findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results.
  • Age and Reproductive Status
  • Males and females, ages 25 to 55 years, inclusive.
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
  • Women must not be breastfeeding.

You may not qualify if:

  • Any significant acute or chronic medical illness.
  • Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug (appendectomies with no complications are allowed at the investigator's discretion).
  • Any major surgery within 4 weeks of study drug administration.
  • Smokers (those who currently smoke, as well as those who have stopped smoking less than 6 months prior to the start of study drug administration).
  • Any other sound medical, psychiatric, and/or social reason as determined by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C

Interventions

EscitalopramSertraline8-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

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds1-NaphthylamineNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Ikenna Ogbaa, MD

    PPD Development, LP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2014

First Posted

June 26, 2014

Study Start

June 1, 2014

Primary Completion

August 1, 2014

Last Updated

February 10, 2015

Record last verified: 2015-02