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

Sponsor

Wockhardt (Industry)

Overall Status

Completed

CT.gov ID

NCT04874324

Collaborator

(none)

Enrollment

Arms

3.3

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics	Drug: WCK 2349 Oral Other: Placebo Oral	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official 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

Actual Study Start Date :

Mar 17, 2011

Actual Primary Completion Date :

May 4, 2011

Actual Study Completion Date :

Jun 25, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: WCK 2349 WCK 2349 800mg, 1000mg, and 1200mg . 1 dose given orally twice daily at 12 hourly interval for five days. Dosage form : Oral	Drug: WCK 2349 Oral 1 dose given orally twice daily at 12 hourly interval for five days.
Placebo Comparator: Placebo Matching Placebo administered as Oral	Other: Placebo Oral Subjects will receive matching placebo

Arm

Intervention/Treatment

Experimental: WCK 2349

WCK 2349 800mg, 1000mg, and 1200mg . 1 dose given orally twice daily at 12 hourly interval for five days. Dosage form : Oral

Drug: WCK 2349 Oral

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

Placebo Comparator: Placebo

Matching Placebo administered as Oral

Other: Placebo Oral

Subjects will receive matching placebo

Outcome Measures

Primary Outcome Measures

To evaluate the safety & tolerability of multiple doses of WCK 2349 [5 days]
To evaluate the pharmacokinetics of multiple doses of WCK 2349 [5 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Wockhardt

Investigators

Study Director: Ashima Bhatia, MD, Wockhardt Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wockhardt

ClinicalTrials.gov Identifier:

NCT04874324

Other Study ID Numbers:

WCK 2349/ P-I/ MD/ 08

First Posted:

May 5, 2021

Last Update Posted:

May 5, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 5, 2021