Study to Evaluate the Effect Of WCK 2349 on the QT/QTc Interval in Health Volunteers

NCT02217930 | Completed Phase 1

• 1 other identifier: W-2349-101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The study designed to determine the effect induced by WCK 2349 on the QT interval. The study will be conducted in two parts: 1) to determine the supratherapeutic dose; and 2) to assess the safety of high doses of single-dose administration of WCK 2349 on the QT interval.

Conditions

Qt Interval, Variation in

Keywords

TQT

Outcome Measures

Primary Outcomes (1)

• Change in QTc interval

  Baseline and 48 hours

Secondary Outcomes (2)

• Highest dose of WCK 2349 tolerated

  Baseline and 48 hours

• Number of Adverse Events

  Baseline and 7 days after the last dose

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo matched to WCK 2349, oral tablet(s) Placebo matched to moxifloxacin overencapsulated tablet

Drug: Placebo

Moxifloxacin

ACTIVE COMPARATOR

Moxifloxacin 400 mg positive control (overencapsulated tablet)

Drug: Moxifloxacin

WCK 2349

EXPERIMENTAL

WCK 2349 supratherapeutic dose determined in Part 1, oral tablet(s)

Drug: WCK 2349

Interventions

WCK 2349 DRUG

WCK 2349

Placebo DRUG

Placebo

Moxifloxacin DRUG

Moxifloxacin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subject between 18 and 55 years of age,inclusive, with a body mass index ≥18 to ≤33 kg/m2.
• Female subjects must be at least 2 years postmenopausal,surgically sterile, or practicing 2 highly effective methods of birth control (determined by the investigator or designee; one of the methods must be a barrier technique), not pregnant or lactating, and have a negative serum pregnancy test before enrolling in the study.
• Male or female subjects must agree to practice 2 highly effective methods of birth control (as determined by the investigator or designee; one of the methods must be a barrier technique) from Screening until 30 days after the last dose of study drug.
• Stable health based on no clinically significant findings on the medical history, physical examination, or clinical laboratory test results (as determined and documented by the investigator).
• Willing to comply with all study activities and procedures and provides written informed consent prior to any study procedures.

You may not qualify if:

• An uninterpretable or abnormal screening electrocardiogram (ECG) indicating a second- or third-degree atrioventricular block, or one or more of the following: QRS interval \>110 milliseconds (msec); QT interval corrected by Fridericia's formula (QTcF) \>430 msec (males) and \>450 msec (females); PR interval \>200 msec; heart rate (HR) \<45 bpm; or any rhythm other than sinus rhythm that is interpreted by the investigator to be clinically significant.
• History of risk factors for torsades de pointes, including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments including hypokalemia, hypercalcemia, or hypomagnesemia. Subjects will also be excluded if there is a family history of long QT syndrome or Brugada syndrome.
• A sustained supine systolic blood pressure \>150 mm Hg or \<90 mm Hg or a supine diastolic blood pressure \>95 mm Hg or \<50 mm Hg at Screening or Check-in (Day -1). Blood pressure may be retested once in the supine position. The blood pressure abnormality is considered sustained if either the systolic or the diastolic pressure values are outside the stated limits after 2 assessments, and the subject may not be randomized.
• A resting HR of \<40 beats per minute or \>100 beats per minute when vital signs are measured at Screening or Check-in (Day -1).
• Unstable cardiovascular disease, including recent myocardial infarction or cardiac arrhythmia.
• Uncontrolled hypertension, asthma, unstable diabetes (type I or type II), thyroid disease, seizures, myasthenia gravis, or any other neuromuscular disorder.
• Women who are pregnant (or planning to become pregnant within the next 6 months) or currently breastfeeding.

Sponsors & Collaborators

• Wockhardt: lead

Study Sites (1)

Phase 1 unit : Spaulding Clinical Research, LLC

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Interventions

levonadifloxacin; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Carlos Sanabria, MD

  Spaulding Clinical Research Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 15, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: July 1, 2015
• Last Updated: October 29, 2015

Record last verified: 2015-10

Locations

US (1)