Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Intravenous WCK 771

Bioavailability Clinical Trial

Official title:

Phase-I, Double-blind, Randomized, Placebo-controlled Single Center Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Intravenous WCK 771 in Adult Healthy Human Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05640531
• Other study ID #: WCK771/P-I/MD/08
• Status: Completed
• Phase: Phase 1
• Start date: December 1, 2011
• Est. completion date: June 27, 2012

Study information

• Verified date: November 2022
• Source: Wockhardt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study is planned to assess the safety and pharmacokinetic profile in normal healthy subjects in US for WCK 771 with doses ranging from 600 mg to 1000 mg BID for 5 days. In the proposed Phase I MAD study, a subject will be administered 600mg, 800mg, and 1000mg WCK 771 BID for 5 days (Ten doses) or an identical placebo as intravenous infusion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 27, 2012
• Est. primary completion date: February 7, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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

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

• Use of any prescription drug within 14 days prior to start of the study (check-in) and nonprescription drug within 7 days prior to start of study (check-in)

Related Conditions & MeSH terms

• Bioavailability

Intervention

Drug:
• WCK 771 IV Infusion
subjects will receive intravenous infusion of WCK 771

Other:
• Placebo IV Infusion
subjects will receive matching placebo intravenous infusion

Locations

Country	Name	City	State
United States	PPD Phase I Clinic, 7551 Metro Center Drive, Suite 200	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Wockhardt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety & tolerability of multiple doses of WCK 771	By monitoring the adverse events reported	Day 12
Primary	To evaluate the pharmacokinetics of multiple doses of WCK 771	Measuring Cmax Maximum observed plasma concentration.	Day 5