An Open-Label, Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Multiple-Dose Ciprofloxacin on Ivacaftor and VX-661 in Combination With Ivacaftor

NCT02015507 | Completed Phase 1

• 1 other identifier: VX13-770-017
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the effect of ciprofloxacin on the pharmacokinetics (PK) of ivacaftor and on the pharmacokinetics of VX-661 when administered in combination with ivacaftor

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (2)

• PK parameters of ivacaftor and metabolites following concomitant dosing with ciprofloxacin relative to ivacaftor administered alone

  PK Parameters - maximum observed plasma concentrations (Cmax) and area under the concentration versus time curve (AUC),

  Day 7, Day 14

• PK parameters of VX-661 and metabolites when dosed in combination with ivacaftor and concomitant ciprofloxacin relative to VX-661 administered in combination with ivacaftor

  PK parameters - maximum observed plasma concentrations (Cmax) and area under the concentration versus time curve (AUC),

  Day 10, Day 20

Secondary Outcomes (2)

• PK parameters of ivacaftor and metabolites when administered in combination with VX-661, with and without concomitant ciprofloxacin

  Day 10, Day 20

• Safety and tolerability, as assessed by adverse events (AEs), vital signs, ECGs and laboratory assessments

  Day 1 through Day 21 (cohort 1) or Day 34 (cohort2)

Study Arms (2)

Cohort 1

ACTIVE COMPARATOR

participants in Cohort 1 will be administered ivacaftor alone followed by ivacaftor with concomitant ciprofloxacin.

Drug: ivacaftor; Drug: ciprofloxacin

Cohort 2

EXPERIMENTAL

Participants in Cohort 2 will be administered VX-661 in combination with ivacaftor followed by VX-661 in combination with ivacaftor and concomitant ciprofloxacin

Drug: ivacaftor; Drug: VX-661; Drug: ciprofloxacin

Interventions

ivacaftor DRUG

Cohort 1; Cohort 2

VX-661 DRUG

Cohort 2

ciprofloxacin DRUG

Cohort 1; Cohort 2

Eligibility Criteria

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

You may qualify if:

• Willing and able to comply with scheduled visits, treatment plan, study restrictions,laboratory tests, contraception guidelines, and other study procedures
• Healthy subjects, as defined by no clinically relevant abnormalities identified by a detailed medical history and full physical examination, including blood pressure and heart rate measurement, standard 12-lead ECG, and clinical laboratory tests.
• Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight \>50 kg
• Female subjects of childbearing potential must have a negative serum pregnancy test at screening and at the Day -1 Visit.

You may not qualify if:

• History of any illness, clinical condition, or other factor that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
• Inability to swallow capsules, or inadequate venous access.
• History of febrile illness within 5 days before the first study drug dose
• A screen positive for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus 1 or 2 antibodies.
• For female subjects: Pregnant or nursing subjects and female subjects of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol. For male subjects: Subject has a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 120 days after the last study drug dose.
• Any condition possibly affecting drug absorption
• Abnormal renal function at screening

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

ivacaftor; tezacaftor; Ciprofloxacin

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

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Medical Monitor

  Vertex Pharmaceutical Incorporated

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 19, 2013
• Study Start: January 1, 2014
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 26, 2014

Record last verified: 2014-03