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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02015507
• Other study ID #: VX13-770-017
• Status: Completed
• Phase: Phase 1
• First received: December 9, 2013
• Last updated: March 25, 2014
• Start date: January 2014
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis

Intervention

Drug:
• ivacaftor

• VX-661

• ciprofloxacin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	PK parameters of ivacaftor and metabolites when administered in combination with VX-661, with and without concomitant ciprofloxacin	PK Parameters - maximum observed plasma concentrations (Cmax) and area under the concentration versus time curve (AUC),	Day 10, Day 20	No
Secondary	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)	Yes