NCT02103569

Brief Summary

The purpose of this study is to assess the effect of DCV/ASV/BMS-791325 fixed dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of the oral contraceptive agent.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

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

First Submitted

Initial submission to the registry

April 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
3 months 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
Last Updated

August 15, 2014

Status Verified

August 1, 2014

Enrollment Period

3 months

First QC Date

April 1, 2014

Last Update Submit

August 13, 2014

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (2)

  • Area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone

    Day 21 to Day 49

  • Maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone

    Day 21 to Day 49

Secondary Outcomes (7)

  • Dose-normalized area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone

    Day 1 to Day 50

  • Dose-normalized maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone

    Day 1 to Day 50

  • Time of maximum observed plasma concentration (Tmax) of Ethinyl Estradiol and Norethindrone

    Day 1 to Day 50

  • Safety measured by occurrence of Adverse events (AEs), serious AEs and AEs leading to discontinuation

    Day 1 to Day 50

  • Safety measured by abnormalities in vital sign measurements

    Day 1 to Day 50

  • +2 more secondary outcomes

Study Arms (1)

Arm 1: FDC of NE/EE + DCV 3DAA FDC + BMS-791325

EXPERIMENTAL

Cycle 1- Low dose FDC of Norethindrone and Ethinyl Estradiol tablet orally on specified days Cycle 2- High dose FDC of Norethindrone and Ethinyl Estradiol tablet orally on specified days and High dose FDC of Norethindrone and Ethinyl Estradiol + FDC of Daclatasvir, Asunaprevir and BMS-791325 + BMS-791325 tablets orally on specified days

Drug: FDC of Daclatasvir, Asunaprevir and BMS-791325Drug: FDC of Norethindrone and Ethinyl EstradiolDrug: BMS-791325

Interventions

FDC of Daclatasvir, Asunaprevir and BMS-791325DRUG
Arm 1: FDC of NE/EE + DCV 3DAA FDC + BMS-791325
FDC of Norethindrone and Ethinyl EstradiolDRUG
Also known as: Loestrin®
Arm 1: FDC of NE/EE + DCV 3DAA FDC + BMS-791325
BMS-791325DRUG
Arm 1: FDC of NE/EE + DCV 3DAA FDC + BMS-791325

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy females within age of 18-40 years
  • Must be a Women of Childbearing potential
  • Must be on a stable regimen of oral contraceptive therapy for at least 3 consecutive months prior to study start

You may not qualify if:

  • Subjects must not have any significant acute or chronic medical illnesses or conditions precluding safe use of oral contraceptives
  • Prior exposure to DCV, ASV or BMS-791325 within 30 days of dosing on study day 1
  • Smoking within 6 months of study start

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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-carboxamideEthinyl Estradiolnorethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

NorpregnatrienesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

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 1, 2014

First Posted

April 4, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 15, 2014

Record last verified: 2014-08