NCT01018368

Brief Summary

The objectives of this study are to evaluate the effects of multiple doses of rifampin on the single-dose pharmacokinetics of VX 770.

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 Nov 2009

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 23, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

May 10, 2010

Status Verified

May 1, 2010

Enrollment Period

4 months

First QC Date

November 19, 2009

Last Update Submit

May 6, 2010

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • VX 770 pharmacokinetic (PK) parameters

    17 days

Secondary Outcomes (3)

  • VX 770 metabolite PK parameters in plasma

    17 days

  • Rifampin concentration at time zero (C0) and AUC at steady state (AUCtau) following the administration of multiple doses of rifampin

    17 days

  • Safety as measured by adverse events, physical examinations, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments

    17 days

Study Arms (2)

VX-770

EXPERIMENTAL
Drug: VX-770

Rifampin

EXPERIMENTAL
Drug: Rifampin

Interventions

VX-770DRUG

In Period 1, subjects will receive a single oral dose of VX-770 150 mg on Day 1. In Period 2, subjects will receive a single oral dose of VX-770 150 mg on Day 6.

VX-770
RifampinDRUG

In Period 2, subjects will receive a daily oral dose of rifampin 600 mg on Days 1 through 10

Rifampin

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subject must be male and between 18 and 55 years of age
  • Subject must have a body mass index (BMI) from 18 to 30 kg/m2

You may not qualify if:

  • History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject
  • Subjects who have active tuberculosis, human immunodeficiency virus, hepatitis C, or active hepatitis B

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Daytona Beach, Florida, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

ivacaftorRifampin

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • H. Frank Farmer, MD

    Covance CRU, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 19, 2009

First Posted

November 23, 2009

Study Start

November 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

May 10, 2010

Record last verified: 2010-05

Locations

US(1)