HealthyPhase 1NCT02532140
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WCK 5107 Alone and in Combination With Cefepime
A Phase 1 study testing WCK 5107 250 mg to 2000 mg, Cefepime 2000 mg and WCK 5107 1000/2000 mg with Cefepime 2000 mg combination in people with Healthy, run by Wockhardt at 1 site in United States.
Trial summary
To evaluate the safety,tolerability and pharmacokinetics of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- WCK 5107 250 mg to 2000 mg, Cefepime 2000 mg and WCK 5107 1000/2000 mg with Cefepime 2000 mg combination
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Dec 2015
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, 18-55 years of age (both inclusive).
- Have a body mass index of 18-30 kg/m2 (both inclusive) calculated as weight (kg)/height (m2).
- Medical history without any major pathology/surgery in the last 6 months prior to screening.
- Resting supine blood pressure of 90-139 (systolic)/40-89 (diastolic) mmHg and a resting pulse rate of 40-100 beats per minute.
- Calculated creatinine clearance ≥80 mL/min
- Computerized 12-lead ECG recording without signs of clinically significant pathology and showing no clinically significant deviation as judged by the Principal Investigator.
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- Males willing to use double-barrier contraceptive measures and to not donate sperm until 90 days after the follow-up visit.
- Females should not be pregnant or breast feeding (pregnancy will be confirmed by a urine pregnancy test at screening with confirmation by a serum pregnancy test at admission) or of non-childbearing potential at screening.
- Females must be either post-menopausal for at least 1 year, surgically sterile (bilateral oophorectomy or hysterectomy), or practicing 1 of the acceptable methods of birth control.
Who cannot join
- History/evidence of clinically relevant pathology.
- History of clinically significant food or drug allergy, including known hypersensitivity to cefepime or any other related drugs.
- A positive screen result for drugs of abuse/alcohol at admission to the study center.
- Use of prescription medications (with the exception of oral contraceptives and hormone replacement therapy) including nonsteroidal anti-inflammatory drugs or sucralfate or herbal preparations.
- Positive screen result for hepatitis B, hepatitis C, or human immunodeficiency virus at screening.
- Any strenuous activity within 4 days prior to admission to the study center. Strenuous being defined as any hard labor or exercise outside of a subject's usual behavior.
- History of blood donation of more than 500 mL in the last 2 months prior to screening.
- Current use or has used tobacco- or nicotine-containing products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WCK 5107 Alone and in Combination With Cefepime Administered as Single IV Doses in Healthy Human Volunteers
- To evaluate the safety,tolerability and pharmacokinetics of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.
- Conditions
- Healthy
- Being tested
- WCK 5107 250 mg to 2000 mg, Cefepime 2000 mg, WCK 5107 1000/2000 mg with Cefepime 2000 mg combination, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WCK 5107 250 mg to 2000 mgDrug
Cefepime 2000 mgDrug
WCK 5107 1000/2000 mg with Cefepime 2000 mg combinationDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| WCK 5107 | Experimental | A single administration of the investigational product will be administered intravenously in 7 SAD cohorts at different dose level . The SAD cohorts will enroll 10 subjects ( 8 on active drug and 2 on placebo) Receives: Drug: WCK 5107 250 mg to 2000 mg; Drug: Placebo |
| WCK 5107 1000 mg and Cefepime 2000 mg | Experimental | In the crossover cohorts (WCK 5107 and cefepime, both alone and in combination), 9 subjects will receive all 3 treatments. Receives: Drug: WCK 5107 250 mg to 2000 mg; Drug: Cefepime 2000 mg; Drug: WCK 5107 1000/2000 mg with Cefepime 2000 mg combination |
| WCK 5107 2000 mg and Cefepime 2000 mg | Experimental | In the crossover cohorts (WCK 5107 and cefepime, both alone and in combination), 9 subjects will receive all 3 treatments. Receives: Drug: WCK 5107 250 mg to 2000 mg; Drug: Cefepime 2000 mg; Drug: WCK 5107 1000/2000 mg with Cefepime 2000 mg combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - number of adverse events .
To evaluate the safety of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.
Measured: 14 days
Tolerability-measure of laboratory parameters
To evaluate the tolerability of single intravenous doses of WCK
Measured: 14 days
Secondary outcomes (3)
PK- Cmax
To evaluate the PK of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.
Measured: 3 days
PK-AUC
To evaluate the PK of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.
Measured: 3 days
PK-time to Cmax
To evaluate the PK of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532140
- Sponsor's protocol ID
- W-5107-101
- Status last verified
- May 2016
- First submitted
- 3 Aug 2015
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WCK 5107 Alone and in Combination With Cefepime Administered as Single IV Doses in Healthy Human Volunteers
- ClinicalTrials.gov ID
- NCT02532140
- Acronym / sponsor ID
- W-5107-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- WockhardtIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Aug 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Aug 2015 (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.
- To evaluate the safety,tolerability and pharmacokinetics of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| WCK 5107 | Experimental | Drug: WCK 5107 250 mg to 2000 mg, Drug: PlaceboA single administration of the investigational product will be administered intravenously in 7 SAD cohorts at different dose level . The SAD cohorts will enroll 10 subjects ( 8 on active drug and 2 on placebo) |
| WCK 5107 1000 mg and Cefepime 2000 mg | Experimental | Drug: WCK 5107 250 mg to 2000 mg, Drug: Cefepime 2000 mg, Drug: WCK 5107 1000/2000 mg with Cefepime 2000 mg combinationIn the crossover cohorts (WCK 5107 and cefepime, both alone and in combination), 9 subjects will receive all 3 treatments. |
| WCK 5107 2000 mg and Cefepime 2000 mg | Experimental | Drug: WCK 5107 250 mg to 2000 mg, Drug: Cefepime 2000 mg, Drug: WCK 5107 1000/2000 mg with Cefepime 2000 mg combinationIn the crossover cohorts (WCK 5107 and cefepime, both alone and in combination), 9 subjects will receive all 3 treatments. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or female, 18-55 years of age (both inclusive).
- Have a body mass index of 18-30 kg/m2 (both inclusive) calculated as weight (kg)/height (m2).
- Medical history without any major pathology/surgery in the last 6 months prior to screening.
- Resting supine blood pressure of 90-139 (systolic)/40-89 (diastolic) mmHg and a resting pulse rate of 40-100 beats per minute.
- Calculated creatinine clearance ≥80 mL/min
Key exclusion criteria (8 listed)
- History/evidence of clinically relevant pathology.
- History of clinically significant food or drug allergy, including known hypersensitivity to cefepime or any other related drugs.
- A positive screen result for drugs of abuse/alcohol at admission to the study center.
- Use of prescription medications (with the exception of oral contraceptives and hormone replacement therapy) including nonsteroidal anti-inflammatory drugs or sucralfate or herbal preparations.
- Positive screen result for hepatitis B, hepatitis C, or human immunodeficiency virus at screening.
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 5107 250 mg to 2000 mg | Drug | WCK 5107, WCK 5107 1000 mg and Cefepime 2000 mg, WCK 5107 2000 mg and Cefepime 2000 mg |
| Cefepime 2000 mg | Drug | WCK 5107 1000 mg and Cefepime 2000 mg, WCK 5107 2000 mg and Cefepime 2000 mg |
| WCK 5107 1000/2000 mg with Cefepime 2000 mg combination | Drug | WCK 5107 1000 mg and Cefepime 2000 mg, WCK 5107 2000 mg and Cefepime 2000 mg |
| Placebo | Drug | WCK 5107 |
Primary outcome
Safety - number of adverse events .
Time frame: 14 days
To evaluate the safety of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.
Tolerability-measure of laboratory parameters
Time frame: 14 days
To evaluate the tolerability of single intravenous doses of WCK
3 secondary outcomes
PK- Cmax
Time frame: 3 days
PK-AUC
Time frame: 3 days
PK-time to Cmax
Time frame: 3 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 3 May 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 5107 250 mg to 2000 mg, Cefepime 2000 mg and WCK 5107 1000/2000 mg with Cefepime 2000 mg combination in people with Healthy, 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 9 inclusion and 8 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 3 May 2016. 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?
Safety - number of adverse events . (time frame: 14 days). 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 3 May 2016.