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Phase 1, QT/QTC Interval Study in Healthy Subjects

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Vertex Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Cystic Fibrosis

Treatments

Drug: Ivacaftor Placebo
Drug: moxifloxacin hydrochloride
Drug: Ivacaftor
Drug: Lumacaftor Placebo
Drug: Lumacaftor

Study type

Interventional

Funder types

Industry

Identifiers

NCT01910415
VX12-809-008

Details and patient eligibility

About

This study is designed to evaluate the effect of multiple doses of lumacaftor in combination with ivacaftor on cardiac repolarization, as detected by QT/QTc interval corrected for heart rate in healthy subjects.

Enrollment

200 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Subjects must be willing and able to comply with scheduled visits, treatment plan, lifestyle guidelines, laboratory tests, contraceptive guidelines, and other study procedures.
  • Subjects must be healthy, as defined by no clinically relevant abnormalities identified by a detailed medical history, physical examination, including blood pressure and pulse rate measurement, and 12 lead ECG.
  • Subjects must weigh >50kg

Exclusion criteria

  • Abnormal renal function at Screening
  • Plasma donation within 7 days before first study drug dose or blood donation of 1 pint (500mL) within 56 days before first study drug dose
  • Positively screen for Hepatitis B, Hepatitis C, HIV
  • Known hypersensitivity or prior adverse reaction to moxifloxacin or other quinolones
  • Any condition possibly affecting drug absorption (e.g., gastrectomy, or other gastrointestinal tract surgery, except appendectomy or cholecystectomy or polypectomy) or regular use of acid-lowering therapies (H2 blockers, proton pump inhibitors, and antacids).
  • Female subjects who are pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last study drug dose and female subjects of childbearing potential who are unwilling or unable to follow the contraceptive guidelines from at least 14 days before the first study drug dose.
  • Male subject who has a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last study drug dose; male subjects who are unwilling or unable to follow the contraceptive guidelines

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

200 participants in 2 patient groups

Part A
Experimental group
Description:
Will consist of up to 4 cohorts with subjects receiving lumacaftor or placebo for 7 days. Cohort 1: 600 mg lumacaftor once a day Cohort 2: 1000 mg lumacaftor once a day Cohort 3: 1200 mg lumacaftor once a day
Treatment:
Drug: Lumacaftor Placebo
Drug: Lumacaftor
Part B
Experimental group
Description:
Will consist of 3 cohorts. All cohorts will be dosed in parallel. Cohort A will receive 600 mg Lumacaftor once a day plus 250 mg Ivacaftor twice a day for 7 days. From day 8-14 subjects will receive a supratherapeutic dose of Lumacaftor (TBD) plus 450 mg Ivacaftor twice a day. Cohort B will receive lumacaftor and ivacaftor matching placebo for 14 days Cohort C will receive a single dose of 400 mg moxifloxacin on day 14
Treatment:
Drug: Lumacaftor Placebo
Drug: Lumacaftor
Drug: Ivacaftor Placebo
Drug: Ivacaftor
Drug: moxifloxacin hydrochloride

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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