HealthyPhase 1NCT03981887
Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin
A Phase 1 study testing Nafithromycin in people with Healthy, run by Wockhardt at 1 site in United States.
Trial summary
This will be a Phase 1, randomized, double-blind, single-center, placebo-controlled study in healthy male and female adult subjects. Subjects will be randomly assigned to receive either nafithromycin or placebo by intravenous (IV) infusion based on a double-blind randomization schedule. 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?
- Nafithromycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2019to 7 Aug 2019
- 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 to ≤32 kg/m2, both inclusive.
- Stable health based on a medical history without any major pathology/surgery in the 6 months before Screening and no clinically significant physical examination findings or clinical laboratory test results
- Resting supine blood pressure of 90 to 139 mmHg (systolic) and 60 to 89 mmHg (diastolic) and a resting heart rate of 50 to 100 beats per minute at Screening and Check-in (Day -1).
- Calculated creatinine clearance ≥80 mL/min (Cockroft-Gault method) at Screening.
- Computerized 12-lead electrocardiogram (ECG) recording without signs of clinically significant pathology and showing no clinically significant deviation as judged by the investigator
Who cannot join
- Participation in another investigational drug or device study or treated with an investigational product within 30 days or 5 half-lives, whichever is longer, before study drug administration in this study.
- History/evidence of clinically relevant pathology
- History of clinically significant food or drug allergy
- Positive alcohol or urine drug screen
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Clinical Research
West Bend, Wisconsin, 53095
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin in Healthy Subjects
This will be a Phase 1, randomized, double-blind, single-center, placebo-controlled study in healthy male and female adult subjects. Subjects will be randomly assigned to receive either nafithromycin or placebo by intravenous (IV) infusion based on a double-blind randomization schedule. The following treatments will be administered:
- Nafithromycin 200 mg or placebo administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days.
- Eight subjects (n=8) will receive nafithromycin and 2 subjects (n=2) will receive placebo.
- Conditions
- Healthy
- Being tested
- Nafithromycin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NafithromycinDrug
Nafithromycin 200 mg as IV infusion
PlaceboOther
placebo administered as IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Nafithromycin 200 mg as IV infusion | Experimental | Nafithromycin 200 mg administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days. Receives: Drug: Nafithromycin |
| placebo administered as IV infusion | Placebo comparator | Placebo administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess safety
By measuring treatment emergent AEs
Measured: Day 19
To assess multiple dose drug tolerability
By measuring treatment emergent AEs
Measured: Day 19
Secondary outcomes (4)
To assess plasma PK parameters profile
Area under the plasma concentration-time curve (AUC)
Measured: Day 3
To assess plasma PK parameters profile
Maximum observed plasma concentration (Cmax)
Measured: Day 3
To assess plasma PK parameters profile
Time to Cmax (Tmax)
Measured: Day 3
To assess plasma PK parameters profile
Terminal half-life (t1/2)
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start18 Jun 2019
- Primary completion2 Jul 2019
- Study completion7 Aug 2019
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinartis, LLC, Keystone Bioanalytical, Inc.
- Responsible party
- Sponsor
- Investigators
- Carlos Sanabria, MD, Principal investigator, Spaulding Clinical Research LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981887
- Sponsor's protocol ID
- W-4873-105
- Status last verified
- Oct 2019
- First submitted
- 6 Jun 2019
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03981887
- Acronym / sponsor ID
- W-4873-105
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- WockhardtIndustry (pharma, biotech, devices)
- Collaborators
- Clinartis, LLC, Keystone Bioanalytical, Inc.
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 2 Jul 2019 (actual)
- Study completion
- 7 Aug 2019 (actual)
- First posted
- 11 Jun 2019 (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.
This will be a Phase 1, randomized, double-blind, single-center, placebo-controlled study in healthy male and female adult subjects. Subjects will be randomly assigned to receive either nafithromycin or placebo by intravenous (IV) infusion based on a double-blind randomization schedule. The following treatments will be administered:
- Nafithromycin 200 mg or placebo administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days.
- Eight subjects (n=8) will receive nafithromycin and 2 subjects (n=2) will receive placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nafithromycin 200 mg as IV infusion | Experimental | Drug: NafithromycinNafithromycin 200 mg administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days. |
| placebo administered as IV infusion | Placebo comparator | Other: PlaceboPlacebo administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index (BMI) ≥18 to ≤32 kg/m2, both inclusive.
- Stable health based on a medical history without any major pathology/surgery in the 6 months before Screening and no clinically significant physical examination findings or clinical laboratory test results
- Resting supine blood pressure of 90 to 139 mmHg (systolic) and 60 to 89 mmHg (diastolic) and a resting heart rate of 50 to 100 beats per minute at Screening and Check-in (Day -1).
- Calculated creatinine clearance ≥80 mL/min (Cockroft-Gault method) at Screening.
- Computerized 12-lead electrocardiogram (ECG) recording without signs of clinically significant pathology and showing no clinically significant deviation as judged by the investigator
Key exclusion criteria (4 listed)
- Participation in another investigational drug or device study or treated with an investigational product within 30 days or 5 half-lives, whichever is longer, before study drug administration in this study.
- History/evidence of clinically relevant pathology
- History of clinically significant food or drug allergy
- Positive alcohol or urine drug screen
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 |
|---|---|---|
| NafithromycinNafithromycin 200 mg as IV infusion | Drug | Nafithromycin 200 mg as IV infusion |
| Placeboplacebo administered as IV infusion | Other | placebo administered as IV infusion |
Primary outcome
To assess safety
Time frame: Day 19
By measuring treatment emergent AEs
To assess multiple dose drug tolerability
Time frame: Day 19
By measuring treatment emergent AEs
4 secondary outcomes
To assess plasma PK parameters profile
Time frame: Day 3
To assess plasma PK parameters profile
Time frame: Day 3
To assess plasma PK parameters profile
Time frame: Day 3
To assess plasma PK parameters profile
Time frame: Day 3
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 2 Oct 2019.
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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.
Carlos Sanabria, MD principal investigator
Spaulding Clinical Research LLC
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 Nafithromycin 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 5 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 2 Oct 2019. 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 assess safety (time frame: Day 19). 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 2 Oct 2019.