BioavailabilityPhase 1NCT05640531
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Intravenous WCK 771
A Phase 1 study testing WCK 771 IV Infusion in people with Bioavailability, run by Wockhardt at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- WCK 771 IV Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2011to 27 Jun 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
PPD Phase I Clinic, 7551 Metro Center Drive, Suite 200
Austin, Texas, 78744
About this study
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
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.
- Conditions
- Bioavailability
- Being tested
- WCK 771 IV Infusion, Placebo IV Infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WCK 771 IV InfusionDrug
subjects will receive intravenous infusion of WCK 771
Placebo IV InfusionOther
subjects will receive matching placebo intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| WCK 771 | Experimental | WCK 771 600mg, 800mg, and 1000mg WCK 771 BID. Dosage form : IV Infusion Receives: Drug: WCK 771 IV Infusion |
| Placebo infusion | Placebo comparator | Matching Placebo administered as IV infusion Receives: Other: Placebo IV Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety & tolerability of multiple doses of WCK 771
By monitoring the adverse events reported
Measured: Day 12
To evaluate the pharmacokinetics of multiple doses of WCK 771
Measuring Cmax Maximum observed plasma concentration.
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start1 Dec 2011
- Primary completion7 Feb 2012
- Study completion27 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashima Bhatia, MD, Study director, Wockhardt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640531
- Sponsor's protocol ID
- WCK771/P-I/MD/08
- Status last verified
- Nov 2022
- First submitted
- 30 Apr 2021
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05640531
- Acronym / sponsor ID
- WCK771/P-I/MD/08
- Conditions
- Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- WockhardtIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2011 (actual)
- Primary completion
- 7 Feb 2012 (actual)
- Study completion
- 27 Jun 2012 (actual)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WCK 771 | Experimental | Drug: WCK 771 IV InfusionWCK 771 600mg, 800mg, and 1000mg WCK 771 BID. Dosage form : IV Infusion |
| Placebo infusion | Placebo comparator | Other: Placebo IV InfusionMatching Placebo administered as IV infusion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WCK 771 IV Infusionsubjects will receive intravenous infusion of WCK 771 | Drug | WCK 771 |
| Placebo IV Infusionsubjects will receive matching placebo intravenous infusion | Other | Placebo infusion |
Primary outcome
To evaluate the safety & tolerability of multiple doses of WCK 771
Time frame: Day 12
By monitoring the adverse events reported
To evaluate the pharmacokinetics of multiple doses of WCK 771
Time frame: Day 5
Measuring Cmax Maximum observed plasma concentration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashima Bhatia, MD study director
Wockhardt Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WCK 771 IV Infusion in people with Bioavailability, run by Wockhardt at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety & tolerability of multiple doses of WCK 771 (time frame: Day 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.