Effect of FoodPhase 1NCT01875939
Phase I, Open Label,Crossover Food-Effect and Absolute Bioavailability Study of WCK2349 and WCK771 in Healthy Adult Human Volunteers
A Phase 1 study testing Oral WCK2349 and IV WCK771 in people with Effect of Food, run by Wockhardt at 1 site in United States.
Trial summary
This study is aimed to ascertain the effect of food on pharmacokinetics of WCK 2349 and determine the absolute bioavailability of WCK 2349 1000 mg (oral, QD dose) with respect to WCK 771 800 mg (intravenous, QD dose). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Food
- What is being tested?
- Oral WCK2349 and IV WCK771
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jun 2013
- 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
- If female, postmenopausal for at least 1 year,surgically sterile or birth control measures.
- Body Mass Index (BMI) between 18 and 32
- No significant diseases
- No recent history of smoking or alcohol
Who cannot join
- Known history of hypersensitivity or idiosyncratic reaction to quinolones or any other related drugs.
- 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.
- No receipt of a prescription drug or non-prescription drug .
Trial locations and contacts
1 site in 1 country.
United States1 site
PPD Phase I unit, 7551 Metro Center Drive, Suite 200
Austin, Texas, 78744
About this study
Official title: Phase-I Randomized, Open Label, Crossover Food-Effect and Absolute Bioavailability Study of WCK 2349 and WCK 771 in Healthy Adult Human Volunteers
This study is aimed to ascertain the effect of food on pharmacokinetics of WCK 2349 and determine the absolute bioavailability of WCK 2349 1000 mg (oral, QD dose) with respect to WCK 771 800 mg (intravenous, QD dose).
This study would ascertain/confirm the therapeutically equivalent oral and IV doses of WCK 2349 and WCK 771 respectively, and provide guidance in case of switch over therapy (WCK 771, IV to WCK 2349, oral) in future clinical trials in patients.
Read the detailed description
All the subjects will be checked-in into the clinical study facility on Day -1, the day prior to dosing. The subjects will be randomly assigned to receive WCK 2349 1000 mg as an oral dose in fed or fasting state (1:1) in the food effect study as per the randomization schedule. The subjects completing the food effect study (i.e., Period 1 and Period 2) will be administered WCK 771 800 mg as an intravenous infusion in fasting state in Period 3 of the study. There will be a washout period of three days between each period. The subjects will continue to remain in the clinical facility for the entire duration of the study (completion of three periods in the study), including wash out period. Prior to check out procedure, detailed clinical examination will be done to confirm that subject has no safety issues.
- Conditions
- Effect of Food
- Being tested
- Oral WCK2349, IV WCK771
- Keywords
- healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral WCK2349Drug
The subjects will be randomly assigned to receive WCK 2349 1000 mg as an oral dose in fed or fasting state (1:1) in the food effect study as per the randomization schedule. The subjects completing the food effect study (i.e., Period 1 and Period 2) will be administered WCK 771 800 mg as an intravenous infusion in fasting state in Period 3 of the study.
IV WCK771Drug
The subjects will be randomly assigned to receive WCK 2349 1000 mg as an oral dose in fed or fasting state (1:1) in the food effect study as per the randomization schedule. The subjects completing the food effect study (i.e., Period 1 and Period 2) will be administered WCK 771 800 mg as an intravenous infusion in fasting state in Period 3 of the study.
| Study group | Role | What they receive |
|---|---|---|
| Oral WCK 2349 fed/fasting | Other | This is a single center, randomized, open label, 2X2 oral IV cross over, food-effect and absolute bioavailability study. The study will be conducted in three parts i.e., Period 1 and Period 2 (foodeffect study) and Period 3 (absolute bioavailability study). Receives: Drug: Oral WCK2349 |
| IV WCK771 | Other | This is a single center, randomized, open label, 2X2 oral IV cross over, food-effect and absolute bioavailability study. The study will be conducted in three parts i.e., Period 1 and Period 2 (foodeffect study) and Period 3 (absolute bioavailability study). Receives: Drug: IV WCK771 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate pharmacokinetics of WCK 2349 (Fed/Fasting)and WCK 771 Fasting
To compare the pharmacokinetics of WCK 2349 following oral administration of 1000 mg of WCK 2349 (QD, one day) in healthy, adult, human subjects in fed and fasting state To determine the absolute bioavailability of WCK 2349 following oral administration of 1000 mg of WCK 2349 (QD, one day) with respect to intravenous administration of 800 mg of WCK 771 (QD, one day) in healthy adult human subjects in fasting state.Absolute bioavailability (F) of oral WCK 2349 as compared to intravenous WCK 771 following single dose administration in healthy subjects in fasting state will be calculated as follows: F =AUC i.v /AUC oral *Dose of oral/Dose of IV Summary statistics will be provided for the safety data.
Measured: Approximately 11 days
Secondary outcomes (1)
safety of oral WCK 2349 and intravenous WCK 771 in healthy adult human subjects
Safety assessed by physical, clinical examination, vital sign, laboratory test, ECG recordings and adverse event recording at EOT visit.
Measured: Approximately 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of FoodStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sabiha A Mondal, MD, Principal investigator, PPD Phase I unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875939
- Sponsor's protocol ID
- W 771/2349-101
- Status last verified
- Aug 2013
- First submitted
- 30 May 2013
- Last updated
- 22 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase-I Randomized, Open Label, Crossover Food-Effect and Absolute Bioavailability Study of WCK 2349 and WCK 771 in Healthy Adult Human Volunteers
- ClinicalTrials.gov ID
- NCT01875939
- Acronym / sponsor ID
- W 771/2349-101
- Conditions
- Effect of Food
- Keywords
- healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- WockhardtIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Jun 2013 (estimated)
- 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.
This study is aimed to ascertain the effect of food on pharmacokinetics of WCK 2349 and determine the absolute bioavailability of WCK 2349 1000 mg (oral, QD dose) with respect to WCK 771 800 mg (intravenous, QD dose).
This study would ascertain/confirm the therapeutically equivalent oral and IV doses of WCK 2349 and WCK 771 respectively, and provide guidance in case of switch over therapy (WCK 771, IV to WCK 2349, oral) in future clinical trials in patients.
Detailed description
All the subjects will be checked-in into the clinical study facility on Day -1, the day prior to dosing. The subjects will be randomly assigned to receive WCK 2349 1000 mg as an oral dose in fed or fasting state (1:1) in the food effect study as per the randomization schedule. The subjects completing the food effect study (i.e., Period 1 and Period 2) will be administered WCK 771 800 mg as an intravenous infusion in fasting state in Period 3 of the study. There will be a washout period of three days between each period. The subjects will continue to remain in the clinical facility for the entire duration of the study (completion of three periods in the study), including wash out period. Prior to check out procedure, detailed clinical examination will be done to confirm that subject has no safety issues.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral WCK 2349 fed/fasting | Other | Drug: Oral WCK2349This is a single center, randomized, open label, 2X2 oral IV cross over, food-effect and absolute bioavailability study. The study will be conducted in three parts i.e., Period 1 and Period 2 (foodeffect study) and Period 3 (absolute bioavailability study). |
| IV WCK771 | Other | Drug: IV WCK771This is a single center, randomized, open label, 2X2 oral IV cross over, food-effect and absolute bioavailability study. The study will be conducted in three parts i.e., Period 1 and Period 2 (foodeffect study) and Period 3 (absolute bioavailability study). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- If female, postmenopausal for at least 1 year,surgically sterile or birth control measures.
- Body Mass Index (BMI) between 18 and 32
- No significant diseases
- No recent history of smoking or alcohol
Key exclusion criteria (3 listed)
- Known history of hypersensitivity or idiosyncratic reaction to quinolones or any other related drugs.
- 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.
- No receipt of a prescription drug or non-prescription drug .
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 |
|---|---|---|
| Oral WCK2349The subjects will be randomly assigned to receive WCK 2349 1000 mg as an oral dose in fed or fasting state (1:1) in the food effect study as per the randomization schedule. The subjects completing the food effect study (i.e., Period 1 and Period 2) will be administered WCK 771 800 mg as an intravenous infusion in fasting state in Period 3 of the study. | Drug | Oral WCK 2349 fed/fasting |
| IV WCK771The subjects will be randomly assigned to receive WCK 2349 1000 mg as an oral dose in fed or fasting state (1:1) in the food effect study as per the randomization schedule. The subjects completing the food effect study (i.e., Period 1 and Period 2) will be administered WCK 771 800 mg as an intravenous infusion in fasting state in Period 3 of the study. | Drug | IV WCK771 |
Primary outcome
Evaluate pharmacokinetics of WCK 2349 (Fed/Fasting)and WCK 771 Fasting
Time frame: Approximately 11 days
To compare the pharmacokinetics of WCK 2349 following oral administration of 1000 mg of WCK 2349 (QD, one day) in healthy, adult, human subjects in fed and fasting state To determine the absolute bioavailability of WCK 2349 following oral administration of 1000 mg of WCK 2349 (QD, one day) with respect to intravenous administration of 800 mg of WCK 771 (QD, one day) in healthy adult human subjects in fasting state.Absolute bioavailability (F) of oral WCK 2349 as compared to intravenous WCK 771 following single dose administration in healthy subjects in fasting state will be calculated as follows: F =AUC i.v /AUC oral *Dose of oral/Dose of IV Summary statistics will be provided for the safety data.
1 secondary outcome
safety of oral WCK 2349 and intravenous WCK 771 in healthy adult human subjects
Time frame: Approximately 11 days
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 22 Aug 2013.
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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.
Sabiha A Mondal, MD principal investigator
PPD Phase I unit
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 Oral WCK2349 and IV WCK771 in people with Effect of Food, 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 4 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 22 Aug 2013. 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. 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?
Evaluate pharmacokinetics of WCK 2349 (Fed/Fasting)and WCK 771 Fasting (time frame: Approximately 11 days). 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 22 Aug 2013.