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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04874324

Enrollment

Registered

2021-05-05

Start date

2011-03-17

Completion date

2011-06-25

Last updated

2022-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics

Brief summary

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.

Interventions

OTHERPlacebo Oral

Subjects will receive matching placebo

DRUGWCK 2349 Oral

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

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the pharmacokinetics of multiple doses of WCK 2349	5 days	Measuring Cmax Maximum observed plasma concentration.
To evaluate the safety & tolerability of multiple doses of WCK 2349	12 days	By monitoring the adverse events reported

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026