Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy Subjects
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy Subjects
1 other identifier
interventional
24
1 country
1
Brief Summary
The purpose of this study is to assess the pharmacokinetics and safety of co-administration of VX-770 and VX-809 in healthy adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2009
Shorter than P25 for phase_1
1 active site
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
First Submitted
Initial submission to the registry
August 25, 2009
CompletedFirst Posted
Study publicly available on registry
August 27, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJanuary 5, 2010
January 1, 2010
3 months
August 25, 2009
January 2, 2010
Conditions
Outcome Measures
Primary Outcomes (2)
Pharmacokinetic (PK) parameters of VX-770 and its metabolites in plasma in the presence and absence of VX-809
70 days
PK parameters of VX-809 in plasma in the presence and absence of VX-770
70 days
Secondary Outcomes (1)
Safety as measured by adverse events, physical examination, and clinically significant changes in laboratory values (hematology, chemistry, coagulation, and urinalysis), electrocardiograms (ECGs), and vital signs.
70 days
Study Arms (3)
Treatment Period 1
EXPERIMENTALTreatment Period 2
EXPERIMENTALTreatment Period 3
EXPERIMENTALInterventions
VX-809 capsule, once daily, and VX-770 tablets, once every 12 hours, for 14 days
Eligibility Criteria
You may qualify if:
- Male or female subject between 18 and 55 years of age, inclusive
- Body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive
- Subjects of child-bearing potential and who are sexually active must meet contraception requirements
- Female subject must have a negative serum pregnancy test at screening, Day -1, and throughout the study
You may not qualify if:
- History of any illness 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. This may include but is not limited to a significant history of cardiovascular, central nervous system, hepatobiliary or renal disease, or a history of mental illness
- Participated in a clinical study involving administration of either an investigational or a marketed drug within 60 days or 7 terminal half-lives (whichever is longer) before the Screening visit
- Subject who has received VX-770 or VX-809 in a previous clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Zuidlaren, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Vertex Pharmaceuticals Incorporated
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 25, 2009
First Posted
August 27, 2009
Study Start
September 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
January 5, 2010
Record last verified: 2010-01