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

NCT01216046 | Completed Phase 1

• 1 other identifier: VX10-809-006
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the pharmacokinetics and safety of VX-809 and VX-770 alone and in combination in healthy subjects.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (2)

• PK parameters (including concentration, exposure and half-life) of VX-809 and its metabolite in plasma in the presence and absence of VX 770

  Blood samples drawn during the study will be analyzed to measure the PK parameters, such as concentration, exposure and half-life of VX-809 and its metabolite.

  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

  Blood samples drawn during the study will be analyzed to measure the PK parameters, such as concentration, exposure and half-life of VX-770 and its metabolites.

  70 days

Secondary Outcomes (1)

• 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

  70 days

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Subjects randomized to study drug will take VX-809 for 14 days followed by a 14 day washout. Next subjects will take VX-770 for 14 days followed by a 14 day washout. Lastly, subjects will take both VX-809 and VX-770 for 14 days.

Drug: VX-809; Drug: VX-770

Placebo Arm

PLACEBO COMPARATOR

Subjects randomized to placebo will take VX-809 placebo for 14 days followed by a 14 day washout. Next subjects will take VX-770 placebo for 14 days followed by a 14 day washout. Lastly, subjects will take both VX-809 and VX-770 placebo for 14 days.

Drug: VX-809 placebo; Drug: VX-770 placebo

Interventions

VX-809 DRUG

capsule, taken once daily

Treatment Arm

VX-770 DRUG

tablet, taken once every 12 hours

Treatment Arm

VX-809 placebo DRUG

capsule, taken once daily

Placebo Arm

VX-770 placebo DRUG

tablet, taken once every 12 hours

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 the contraception requirements
• Female subject must have a negative serum pregnancy test at screening and Day -1

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
• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

PRA

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

lumacaftor; ivacaftor

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Laurent Vernillet, PharmD, PhD, FCP

  Vertex Pharmaceuticals Incorporated

  STUDY DIRECTOR

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: October 7, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: January 18, 2012

Record last verified: 2012-01

Locations

US (1)