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Drug & research development » Clinical trials » NCT01910415

Phase 1, QT/QTC Interval Study in Healthy Subjects

Official title: A Phase 1, Randomized, Placebo and Active Controlled, Double-Blind, Parallel, Electrocardiogram Study to Evaluate the Effect of Lumacaftor in Combination With Ivacaftor on the QT/QTc Interval in Healthy Subjects

Clinical Trials gov number: NCT01910415

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Purpose: To evaluate the effect of multiple doses of VX-809 in combination with ivacaftor on cardiac repolarization, as detected by QT/QTc interval corrected for heart rate in healthy subjects.

Phase: 1

Type: Interventional, randomized, double-blind, factorial assignment

Study sponsor: Vertex Pharmaceuticals Incorporated

  • 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

Intervention
Ivacaftor, Lumacaftor, moxifloxacin hydrochloride

Geographical Location
Netherlands

Number of Participants
101-1000 (18-55 years)

Primary Endpoint

Part A

  • Safety and tolerability of lumacaftor as measured by standard 12-lead ECGs, adverse events, vital signs, spirometry, and clinically significant laboratory assessments (7 days)

Part B

  • Time matched, baseline-adjusted change in QTcF intervals obtained from a continuous ECG recording over a 24 hour interval after administration of a therapeutic and supratherapeutic dose of lumacaftor in combination with ivacaftor (7 days)

Secondary Endpoint

Part A

  • PK parameters of lumacaftor and M28-lumacaftor in plasma including Cmax and AUC (up to 11 days)

Part B

  • Time-matched, baseline-adjusted QTcF intervals obtained after a single 400-mg dose of moxifloxacin (up to 14 days)
  • Time-matched, baseline-adjusted non-QT interval parameters obtained from a continuous ECG recording over a 24-hour interval (up to 14 days)
  • PK parameters of lumacaftor, M28-lumacaftor, ivacaftor, M1-ivacaftor, and M6-ivacaftor including Cmax and AUC (up to 15 days)
  • PK/PD relationship between plasma concentration and QT/QTc interval (up to 14 days)
  • Safety and tolerability of lumacaftor in combination with ivacaftor as measured by standard 12-lead ECGs, AEs, vital signs, and clinical significant laboratory results (up to 24 days)

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  • Experimental: Part A

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

  • Experimental: Part B

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

View Trial Results