Condition or disease | Intervention/treatment | Phase |
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Healthy | Drug: WCK 4873 Drug: Placebo Oral Tablet | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Other |
Official Title: | Double-Blind, Randomized, Placebo-Controlled Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers |
Actual Study Start Date : | August 20, 2013 |
Actual Primary Completion Date : | December 5, 2013 |
Actual Study Completion Date : | December 30, 2013 |
Arm | Intervention/treatment |
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Experimental: WCK 4873
200 and 400 mg tablets Dosage form : Oral tablets Doses : To be determined based on the safety, tolerability and PK results of the single dose and food effect study
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Drug: WCK 4873 |
Placebo Comparator: Placebo
Visually matching placebo
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Drug: Placebo Oral Tablet |
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
No Contacts or Locations Provided
Tracking Information | |||
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First Submitted Date ICMJE | April 3, 2019 | ||
First Posted Date ICMJE | June 7, 2019 | ||
Last Update Posted Date | June 11, 2019 | ||
Actual Study Start Date ICMJE | August 20, 2013 | ||
Actual Primary Completion Date | December 5, 2013 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | No Changes Posted | ||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Evaluate The Safety, Tolerability and Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers | ||
Official Title ICMJE | Double-Blind, Randomized, Placebo-Controlled Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers | ||
Brief Summary | This is a Phase 1, randomized, double-blind, single center, placebo-controlled, sequential cohort study in a maximum of 3 cohorts of 10 healthy male and/or female subjects each. Subjects in Cohorts 1, 2 and 3 will receive ascending multiple oral doses of WCK 4873 or matching placebo once daily on Days 1 to 7. Dosing will be conducted under fed conditions on each dosing day. The dose levels to be administered will be based on the safety, tolerability and PK results of the single dose and food effect study (W 4873 01 study; PRA-code WOE384EC-123841). | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 1 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Other |
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Condition ICMJE | Healthy | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
30 | ||
Original Actual Enrollment ICMJE | Same as current | ||
Actual Study Completion Date ICMJE | December 30, 2013 | ||
Actual Primary Completion Date | December 5, 2013 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | Yes | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Not Provided | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT03979859 | ||
Other Study ID Numbers ICMJE | W 4873 02 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Wockhardt | ||
Study Sponsor ICMJE | Wockhardt | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Wockhardt | ||
Verification Date | June 2019 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |