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Completed

NCT Number: NCT04874324

Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349

The present study is planned to assess the safety, tolerability and pharmacokinetic profile of WCK 2349 in US subjects with selected ascending multiple doses of WCK 2349 and to compare the safety, tolerability and pharmacokinetic data with the data observed in similar studies conducted in India.

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Key information

Conditions

Pharmacokinetics

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Must be healthy males or non-pregnant females
  • Have a Body Mass Index (BMI) between 18 and 32 (both inclusive), calculated as weight in kg / height in m2
  • Have no significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations and ECG recordings.
  • Should test negative for drugs of abuse and urine alcohol test.

Exclusion criteria

  • Known hypersensitivity or idiosyncratic reaction to quinolones or any other related drugs.
  • Any history or evidence of disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.

Treatment and study plan

WCK 2349 Oral

Drug

1 dose given orally twice daily at 12 hourly interval for five days.

Placebo Oral

Other

Subjects will receive matching placebo

Primary outcomes

  1. To evaluate the safety & tolerability of multiple doses of WCK 2349

    Time frame: 12 days

    By monitoring the adverse events reported

  2. To evaluate the pharmacokinetics of multiple doses of WCK 2349

    Time frame: 5 days

    Measuring Cmax Maximum observed plasma concentration.

Sponsors and collaborators

Lead sponsor

Wockhardt

Industry

Registry information

Official study title

Phase-I Double-blind, Randomized, Placebo-controlled Single Center Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349 Under Fasting Conditions in Adult Healthy Human Volunteers

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 5, 2021
Registry last updated
Dec 1, 2022

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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