HealthyPhase 1NCT02453529
Study to Determine and Compare Plasma and Intrapulmonary Concentrations of WCK 4873 in Healthy Adult Human Subjects
A Phase 1 study testing WCK 4873 in people with Healthy, run by Wockhardt at 1 site in United States.
Trial summary
This is a Phase 1, multiple dose, open-label pharmacokinetic study conducted in healthy adult male and female subjects. Subjects will receive 3 oral doses of WCK 4873 administered once-daily starting on Day 1. 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 4873
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jul 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
- Body mass index (BMI) 18.5 and 30 (kg/m2) and weight between 55.0 and 100.0 kg (both inclusive).
- Medical history without any major pathology as judged by the Principal Investigator.
- Resting supine blood pressure 100-139 (systolic) or 60-89 (diastolic) mm Hg, a resting pulse rate of 40 beats per minute or higher, and showing no clinically relevant deviations as judged by the Principal Investigator.
Who cannot join
- History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- Positive alcohol breath test or urine drug screen test at screening or confinement.
- Positive testing for HIV, Hepatitis B or Hepatitis C.
- Clinically significant pulmonary or any other disease that prevents a subject from undergoing bronchoscopy with pulmonary lavage.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pulmonary Associates, 1112 E. McDowell Rd.
Phoenix, Arizona, 85006
About this study
Official title: A Phase 1, Multiple-Dose, Open-Label Study to Determine and Compare Plasma and Intrapulmonary Concentrations of WCK 4873 in Healthy Adult Human Subjects
This is a Phase 1, multiple dose, open-label pharmacokinetic study conducted in healthy adult male and female subjects.
Subjects will receive 3 oral doses of WCK 4873 administered once-daily starting on Day 1. Blood collection for determining plasma WCK 4873 concentrations will be conducted within 15 minutes prior to and at 1, 2, 3, 4, 6, 9, 12, and 24 hours after the first dose of WCK 4873. The 24 hours post-dose sample after the first dose will be collected prior to Day 2 dosing. Blood samples for determining plasma WCK 4873 concentrations will also be collected within 15 minutes prior to and at 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours after the third dose. Each subject will undergo one standardized bronchoscopy with bronchoalveolar lavage (BAL) in the outpatient bronchoscopy suite at 3, 6, 9, 12, 24 or 48 hours after the third oral dose of WCK 4873. Subjects scheduled for bronchoscopy at 48 hours will also have blood sample drawn for determining plasma WCK 4873 concentrations at 48 hours after the third dose.
Safety will be assessed throughout the study by adverse event monitoring, clinical laboratory tests (including liver function tests), ECG, physical examination and vital sign monitoring. Subjects will discontinue study drug administration in the event of AST/ALT elevation of greater than 3 times the upper limit of normal.
- Conditions
- Healthy
- Being tested
- WCK 4873
- Keywords
- plasma concentration, pulmonary concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WCK 4873Drug
Oral tablets
| Study group | Role | What they receive |
|---|---|---|
| WCK 4873 | Experimental | Oral tablets Receives: Drug: WCK 4873 |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Epithelial lining fluid (ELF) and alveolar macrophage (AM) will be used to assess the concentrations of oral WCK 4873 in healthy adult subjects
Measured: 48 hrs per dose
Secondary outcomes (2)
• Safety and tolerability of oral WCK 4873 in healthy adult subjects as measure by safety lab assesments, ECGs, physical examinations and AEs captured.
Measured: 8 weeks
• Pharmacokinetic (PK) profile of multiple doses (800 mg) of WCK 4873 in healthy adult subjects
Plasma concentrations of WCK 4873; plasma PK parameters (Cmax, tmax, kel, t½, AUC0-t, AUC0-24, Vd, CL); ELF concentrations of WCK 4873; concentration of WCK 4873 in alveolar macrophages
Measured: 48 hrs last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinartis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453529
- Sponsor's protocol ID
- W-4873-101
- Status last verified
- Jul 2015
- First submitted
- 17 Apr 2015
- Last updated
- 3 Aug 2015
- Results posted
- No
Publications
Rodvold KA, Gotfried MH, Chugh R, Gupta M, Friedland HD, Bhatia A. Comparison of Plasma and Intrapulmonary Concentrations of Nafithromycin (WCK 4873) in Healthy Adult Subjects. Antimicrob Agents Chemother. 2017 Aug 24;61(9):e01096-17. doi: 10.1128/AAC.01096-17. Print 2017 Sep.
PubMed 28696231
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multiple-Dose, Open-Label Study to Determine and Compare Plasma and Intrapulmonary Concentrations of WCK 4873 in Healthy Adult Human Subjects
- ClinicalTrials.gov ID
- NCT02453529
- Acronym / sponsor ID
- W-4873-101
- Conditions
- Healthy
- Keywords
- plasma concentration, pulmonary concentration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- WockhardtIndustry (pharma, biotech, devices)
- Collaborators
- Clinartis
- Study start
- Apr 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 25 May 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.
This is a Phase 1, multiple dose, open-label pharmacokinetic study conducted in healthy adult male and female subjects.
Subjects will receive 3 oral doses of WCK 4873 administered once-daily starting on Day 1. Blood collection for determining plasma WCK 4873 concentrations will be conducted within 15 minutes prior to and at 1, 2, 3, 4, 6, 9, 12, and 24 hours after the first dose of WCK 4873. The 24 hours post-dose sample after the first dose will be collected prior to Day 2 dosing. Blood samples for determining plasma WCK 4873 concentrations will also be collected within 15 minutes prior to and at 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours after the third dose. Each subject will undergo one standardized bronchoscopy with bronchoalveolar lavage (BAL) in the outpatient bronchoscopy suite at 3, 6, 9, 12, 24 or 48 hours after the third oral dose of WCK 4873. Subjects scheduled for bronchoscopy at 48 hours will also have blood sample drawn for determining plasma WCK 4873 concentrations at 48 hours after the third dose.
Safety will be assessed throughout the study by adverse event monitoring, clinical laboratory tests (including liver function tests), ECG, physical examination and vital sign monitoring. Subjects will discontinue study drug administration in the event of AST/ALT elevation of greater than 3 times the upper limit of normal.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WCK 4873 | Experimental | Drug: WCK 4873Oral tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) 18.5 and 30 (kg/m2) and weight between 55.0 and 100.0 kg (both inclusive).
- Medical history without any major pathology as judged by the Principal Investigator.
- Resting supine blood pressure 100-139 (systolic) or 60-89 (diastolic) mm Hg, a resting pulse rate of 40 beats per minute or higher, and showing no clinically relevant deviations as judged by the Principal Investigator.
Key exclusion criteria (4 listed)
- History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- Positive alcohol breath test or urine drug screen test at screening or confinement.
- Positive testing for HIV, Hepatitis B or Hepatitis C.
- Clinically significant pulmonary or any other disease that prevents a subject from undergoing bronchoscopy with pulmonary lavage.
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 4873Oral tablets | Drug | WCK 4873 |
Primary outcome
• Epithelial lining fluid (ELF) and alveolar macrophage (AM) will be used to assess the concentrations of oral WCK 4873 in healthy adult subjects
Time frame: 48 hrs per dose
2 secondary outcomes
• Safety and tolerability of oral WCK 4873 in healthy adult subjects as measure by safety lab assesments, ECGs, physical examinations and AEs captured.
Time frame: 8 weeks
• Pharmacokinetic (PK) profile of multiple doses (800 mg) of WCK 4873 in healthy adult subjects
Time frame: 48 hrs last dose
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 Aug 2015.
- Derived from this study: PubMed 28696231Rodvold KA, Gotfried MH, Chugh R, Gupta M, Friedland HD, Bhatia A. Comparison of Plasma and Intrapulmonary Concentrations of Nafithromycin (WCK 4873) in Healthy Adult Subjects. Antimicrob Agents Chemother. 2017 Aug 24;61(9):e01096-17. doi: 10.1128/AAC.01096-17. Print 2017 Sep.
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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 4873 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 3 inclusion and 4 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 Aug 2015. 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?
• Epithelial lining fluid (ELF) and alveolar macrophage (AM) will be used to assess the concentrations of oral WCK 4873 in healthy adult subjects (time frame: 48 hrs per dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02453529, which also lists 1 linked publication.
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 Aug 2015.