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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01216046
• Date of registration: 29/09/2010
• Prospective Registration: Yes
• Primary sponsor: Vertex Pharmaceuticals Incorporated
• Public title: Drug-Drug Interaction Study of VX-770 and VX-809 in Healthy Subjects
• Scientific title: A Phase 1, Randomized, Double-Blind, Placebo Controlled, Multiple-Dose, Dose-Escalation, Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy Subjects
• Date of first enrolment: October 2010
• Target sample size: 48
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01216046
• 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

United States

Contacts

• Name: Laurent Vernillet, PharmD, PhD, FCP
• 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 the
contraception requirements

- Female subject must have a negative serum pregnancy test at screening and Day -1

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

- Participated in a clinical study involving administration of either an
investigational or a marketed drug within 30 days or 5 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-809

Drug: VX-770

Drug: VX-809 placebo

Drug: VX-770 placebo

Primary Outcome(s)

PK parameters (including concentration, exposure and half-life) of VX-809 and its metabolite in plasma in the presence and absence of VX 770 [Time Frame: 70 days]

PK parameters (including concentration, exposure and half-life) of VX-770 and its metabolites in plasma in the presence and absence of VX 809 [Time Frame: 70 days]

Secondary Outcome(s)

Safety and tolerability as measured by adverse events (AEs) and clinically significant changes in laboratory values (clinical chemistry, hematology, coagulation, and urinalysis), electrocardiograms, and vital signs [Time Frame: 70 days]

Secondary ID(s)

VX10-809-006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors