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Completed

NCT Number: NCT03486236

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

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

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Medicines Evaluation Unit

Manchester, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VX-440

Drug

VX-440 was administered in TC with TEZ and IVA.

TEZ

Drug

TEZ was administered as part of a fixed-dose combination (FDC) tablet (TEZ/IVA)

Other names: Tezacaftor, VX-661

IVA

Drug

IVA was administered as part of a FDC tablet (TEZ/IVA) and as a mono tablet

Other names: Ivacaftor, VX-770

Matched Placebos

Drug

Placebos matched to VX-440, TEZ, and IVA.

Primary outcomes

  1. Safety and tolerability were based on the number and assessment of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: from baseline through safety follow-up visit (up to 29 days)

Secondary outcomes

  1. 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)

    Time frame: from Day 1 through Day 18

  2. 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)

    Time frame: from Day 1 through Day 18

  3. 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)

    Time frame: from Day 1 through Day 18

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 3, 2018
Registry last updated
Apr 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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