A Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With Tezacaftor/Ivacaftor in Healthy Adult Subjects

Cystic Fibrosis Clinical Trial

Official title:

A Phase 1, Randomized, Double Blind, Placebo Controlled, Multiple Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With VX-661/Ivacaftor in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03486236
• Other study ID #: VX16-440-002
• Secondary ID: 2016-000762-38
• Status: Completed
• Phase: Phase 1
• First received: March 27, 2018
• Last updated: March 27, 2018
• Start date: July 20, 2016
• Est. completion date: September 14, 2016

Study information

• Verified date: March 2018
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluated the safety and pharmacokinetics of multiple ascending doses of VX-440 in combination with tezacaftor/ivacaftor (TEZ/IVA) (triple combination [TC]) administered for 13 days to healthy male and female subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 14, 2016
• Est. primary completion date: September 14, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Female subjects of non-childbearing potential only.

• Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight >50 kg.

• Normal pulmonary function measurements, defined as forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) both =80% of their predicted value at screening.

Exclusion Criteria:

• For female subjects: Pregnant or nursing subjects.

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency.

• History of hemolysis.

• Total bilirubin level >2 × ULN at Screening.

Other protocol defined Inclusion/Exclusion criteria applied.

Related Conditions & MeSH terms

• Cystic Fibrosis

Intervention

Drug:
• VX-440
VX-440 was administered in TC with TEZ and IVA.
• TEZ
TEZ was administered as part of a fixed-dose combination (FDC) tablet (TEZ/IVA)
• IVA
IVA was administered as part of a FDC tablet (TEZ/IVA) and as a mono tablet
• Matched Placebos
Placebos matched to VX-440, TEZ, and IVA.

Locations

Country	Name	City	State
United Kingdom	The Medicines Evaluation Unit	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability were based on the number and assessment of adverse events (AEs) and serious adverse events (SAEs)		from baseline through safety follow-up visit (up to 29 days)
Secondary	Maximum observed concentration (Cmax) of VX-440, TEZ and its metabolites (M1-TEZ and M2-TEZ), and IVA and its metabolites (M1-IVA and M6-IVA)		from Day 1 through Day 18
Secondary	Area under the concentration versus time curve during a dosing interval (AUCtau) of VX-440, TEZ and its metabolites (M1-TEZ and M2-TEZ), and IVA and its metabolites (M1-IVA and M6-IVA)		from Day 1 through Day 18
Secondary	Observed pre-dose concentration (Ctrough) of VX-440, TEZ and its metabolites (M1-TEZ and M2-TEZ), and IVA and its metabolites (M1-IVA and M6-IVA)		from Day 1 through Day 18