NCT00996879

Brief Summary

The purpose of this study is to assess the effect of BMS-791325 on the pharmacokinetics of the CYP3A4 Probe Midazolam.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2013

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

October 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2009

Completed
3.5 years until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

May 6, 2014

Status Verified

May 1, 2014

Enrollment Period

4 months

First QC Date

October 14, 2009

Last Update Submit

May 5, 2014

Conditions

Hepatitis C

Keywords

Human Volunteers

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics parameters area under curve (AUC) (TAU), maximum concentration (Cmax)

    Within 24 hours of dosing

Secondary Outcomes (1)

  • Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examination and clinical laboratory tests

    On Days 1, 2, 4, 6, 8, 9, and 10

Study Arms (1)

Midazolam + BMS-791325

EXPERIMENTAL
Drug: MidazolamDrug: BMS-791325

Interventions

MidazolamDRUG

Syrup, Oral, 5 mg, Single dose, 2 days

Midazolam + BMS-791325
BMS-791325DRUG

Capsules, Oral, 300 mg, Every 12 hours, 8 days

Midazolam + BMS-791325

Eligibility Criteria

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

You may qualify if:

  • Healthy male and female subjects aged 18 to 49 years, with BMI of 18-32 kg/m²
  • Women who are not of childbearing potential

You may not qualify if:

  • Women of childbearing potential
  • Women who are pregnant, breastfeeding, or unwilling or unable to use an acceptable method of birth control.
  • Gastrointestinal disease that may impact the absorption of study drug
  • History of any chronic respiratory disease (asthma, COPD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wcct Global, Llc

Cypress, California, 90630, United States

Location

Related Links

MeSH Terms

Conditions

Hepatitis C

Interventions

Midazolam8-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)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-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

October 14, 2009

First Posted

October 16, 2009

Study Start

May 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

May 6, 2014

Record last verified: 2014-05

Locations

US(1)