Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00966602
• Date of registration: 25/08/2009
• Prospective Registration: Yes
• Primary sponsor: Vertex Pharmaceuticals Incorporated
• Public title: Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy Subjects
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy Subjects
• Date of first enrolment: September 2009
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00966602
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Netherlands

Contacts

• Name: Medical Monitor
• Affiliation: Vertex Pharmaceuticals Incorporated

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: VX-770

Drug: Placebo

Drug: VX-809

Drug: VX-809 & VX-770

Primary Outcome(s)

PK parameters of VX-809 in plasma in the presence and absence of VX-770 [Time Frame: 70 days]

Pharmacokinetic (PK) parameters of VX-770 and its metabolites in plasma in the presence and absence of VX-809 [Time Frame: 70 days]

Secondary Outcome(s)

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. [Time Frame: 70 days]

Secondary ID(s)

VX08-809-005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors