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

Sponsor
Wockhardt (Industry)
Overall Status
Completed
CT.gov ID
NCT05640531
Collaborator
(none)
36
Enrollment
1
Location
2
Arms
6.9
Actual Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: WCK 771 IV Infusion
  • Other: Placebo IV Infusion
 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 Intravenous WCK 771 in Adult Healthy Human Volunteers
Actual Study Start Date :
Dec 1, 2011
Actual Primary Completion Date :
Feb 7, 2012
Actual Study Completion Date :
Jun 27, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: WCK 771

WCK 771 600mg, 800mg, and 1000mg WCK 771 BID. Dosage form : IV Infusion

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

Matching Placebo administered as IV infusion

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

Outcome Measures

Primary Outcome Measures

  1. To evaluate the safety & tolerability of multiple doses of WCK 771 [Day 12]

    By monitoring the adverse events reported

  2. To evaluate the pharmacokinetics of multiple doses of WCK 771 [Day 5]

    Measuring Cmax Maximum observed plasma concentration.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 PPD Phase I Clinic, 7551 Metro Center Drive, Suite 200 Austin Texas United States 78744

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:
NCT05640531
Other Study ID Numbers:
  • WCK771/P-I/MD/08
First Posted:
Dec 7, 2022
Last Update Posted:
Dec 7, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 7, 2022