AzTrials
AzTrials

PharmacokineticsPhase 1NCT05436678

A Multiple-Dose PK Study to Evaluate the Comparative Bioavailability of PrimeC Tablets to Ciprofloxacin Tablets Co-administered With Celecoxib Capsules, in Healthy Adult Subject

A Phase 1 study testing PrimeC 748 mg, Ciprofloxacin 750 MG and Celecoxib 200mg in people with Pharmacokinetics, run by NeuroSense Therapeutics Ltd. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is an open-label, randomized, multiple-dose, two-treatment, two-period crossover study comparing the test and reference products. In each period of the study, either 2 × PrimeC tablets or reference products (ciprofloxacin co-administered celecoxib) will be administered to subjects every 12 hours for 6.5 days (13… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Pharmacokinetics
What is being tested?
PrimeC 748 mg, Ciprofloxacin 750 MG and Celecoxib 200mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited States
Study dates
26 Jul 2022to 20 Oct 2022
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

  • Males and females, 18-55 years of age, inclusive, with a Body Mass Index (BMI) of 18.5-29.9 kg/m², inclusive.
  • Female subjects must meet at least one of the following criterion:
  • Agree to abstain from sexual intercourse from screening and throughout the duration of the study, with a documented secondary contraceptive method.
  • Have used and agree to continue to use a reliable method of contraception (e.g., hormonal contraceptives, condom with spermicide, IUD) for at least 30 days before initial dosing and throughout the duration of the study.
  • Surgically sterile (bilateral oophorectomy or hysterectomy, bilateral tubal ligation at least 3 months before initial dosing or Essure® device placement before the year 2018).
  • At least 1 year
Show all 9Show fewer
  • Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
  • Signed and dated informed consent form, which meets all criteria of current FDA regulations.
  • Subject understands the requirements of the study and is willing to comply with all study requirements.

Who cannot join

  • Females who are pregnant, lactating or likely to become pregnant during the study.
  • History of allergy or hypersensitivity to ciprofloxacin or other fluoroquinolones, celecoxib or other NSAIDs, any component of the study products, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
  • Significant history or current evidence of chronic infectious disease, system disorders, organ dysfunction especially cardiovascular disorders (e.g., heart failure, edema), respiratory disorders (e.g., asthma), hypertension, renal or hepatic disorders, diabetes or obesity.
  • QTc interval > 450 msec for males or > 470 msec for females or any clinically significant ECG abnormalities that, in the Investigator's opinion, would compromise the subject's safety for inclusion in the study. Significant history or current evidence of risk factors for Torsade de Pointes (TdP) (e.g., cardiac disease, heart failure, clinically significant hypokalemia or other electrolyte disorders, family history of Long QT Syndrome), as determined by the Investigator.
  • History or current evidence of myasthenia gravis or myasthenic syndrome.
  • History or current evidence of epilepsy, other seizures disorders, or other risk factors that may predispose to seizures or lower the seizure threshold; tendinitis or tendon rupture; peripheral neuropathy or aortic aneurysms.
Show all 24Show fewer
  • Significant acute illness (e.g. acute infection) within 14 days before initial dosing, as determined by the Investigator.
  • Clinically significant history or presence of gastrointestinal disease (e.g., peptic ulcer, gastrointestinal bleeding) or history of malabsorption within the last year, as determined by the Investigator.
  • History of psychiatric disorders (e.g., anxiety, depression, insomnia, confusion) occurring within the last two years, which required the subject to be hospitalized or treated with medication.
  • Presence of a medical condition requiring regular treatment with prescription drugs (except hormonal contraceptives).
  • Use of pharmacologic agents (prescription or over-the-counter) or herbal products known or suspected to induce or inhibit drug-metabolizing enzymes (especially inducers and inhibitors of CYP1A2 and CYP2C9) within 30 days before initial dosing.
  • Use of dietary products (e.g., grapefruit products of all types) known or suspected to induce or inhibit drug-metabolizing enzymes (especially inducers and inhibitors of CYP1A2 and CYP2C9) within 14 days before initial dosing.
  • Use of any prescription medications (other than hormonal contraceptives and those noted above), especially prescription medications implicated in TdP or cardiac arrhythmia, terfenadine, pimozide, ergotamine; dihydroergotamine or over-the-counter medications implicated in TdP or cardiac arrhythmia; medications that interfere with hemostasis (e.g., warfarin, selective serotonin reuptake inhibitors, selective serotonin norepinephrine reuptake inhibitors), other quinolones, digoxin, and NSAIDs or antibiotics (all dosage forms and routes of administration; other than the study drugs) within 14 days before initial dosing.
  • Known or suspected to be a poor CYP2C9 metabolizer.
  • Receipt of any drug as part of a research study within 30 days before initial dosing or 5 half-lives, whichever is longer.
  • Drug or alcohol addiction, as determined by the Investigator, in the 12 months before initial dosing.
  • History of excessive alcohol consumption (on average more than 14 units of alcohol/week) during the past 12 months.
  • Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days before initial dosing.
  • Positive test results for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
  • Positive test results for drugs of abuse or cotinine at screening.
  • If female, has a positive pregnancy test at screening.
  • Use of tobacco- or nicotine-containing products within 90 days before initial dosing.
  • Difficulty swallowing capsules or tablets whole.
  • Unable or unwilling to comply with protocol restrictions and required study procedures.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Novum

    Las Vegas, Nevada, 89121

Other trials in United States

About this study

Official title: An Open Label, Randomized, Multiple-Dose, Two-Treatment, Two-Period, Two-Sequence, Crossover Study to Evaluate the Comparative Bioavailability of PrimeC (Ciprofloxacin and Celecoxib) Tablets to Ciprofloxacin Tablets Co-administered With Celecoxib Capsules, in Healthy Adult Subject

This is an open-label, randomized, multiple-dose, two-treatment, two-period crossover study comparing the test and reference products. In each period of the study, either 2 × PrimeC tablets or reference products (ciprofloxacin co-administered celecoxib) will be administered to subjects every 12 hours for 6.5 days (13 total administrations), in fed conditions.

The subjects will receive the test treatment in one of the study periods and the reference treatment in the other study period according to a two-sequence randomization schedule. Blood samples will be collected before the morning dose on Day 1, before the morning and evening dose on Days 5 and 6, before the morning dose on Day 7 and at intervals over 48 hours after the morning dose on Day 7 (see Section 7.6) in each study period. Subjects will be confined at the clinical facility from at least 10.5 hours before the initial dose on Day 1 until approximately 48 hours after the final dose on Day 7.

Being tested
PrimeC 748 mg, Ciprofloxacin 750 MG, Celecoxib 200mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrimeC 748 mgDrug

    PrimeC is an extended release formulation of a fixed dose combination of ciprofloxacin and celecoxib

  • Ciprofloxacin 750 MGDrug

    Ciprofloxacin

  • Celecoxib 200mgDrug

    Celecoxib

Study groups in NCT05436678
Study groupRoleWhat they receive
PrimeCActive comparator2 PrimeC tablets (total single dose 748 mg) twice daily for 6.5 days following a meal
Receives: Drug: PrimeC 748 mg
Marketed ciprofloxacin and celecoxibActive comparator750 mg of ciprofloxacin and 200 mg of celecoxib, co-administered twice daily for 6.5 days following a meal
Receives: Drug: Ciprofloxacin 750 MG; Drug: Celecoxib 200mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax D1

    Maximum measured plasma concentration over the morning 12-hour dosing interval on Day 1.

    Measured: 1 day

  2. Cmax D7

    Maximum measured plasma concentration over the morning 12-hour dosing interval on Day 7.

    Measured: 7 days

  3. AUC0-12 D1

    Area under the plasma concentration versus time curve from time zero to the end of the morning 12-hour dosing interval on Day 1, as calculated by the linear trapezoidal method.

    Measured: 1 day

  4. AUC0-12 D7

    Area under the plasma concentration time curve over the morning 12-hour dosing interval on Day 7, as calculated by the linear trapezoidal method.

    Measured: 7 days

Secondary outcomes (12)

  1. Cpre Dx

    Measured pre-dose plasma concentration on Days 1, 5, 6 and 7; where D = Day 1, 5, 6 or 7; and x = m (morning dose) or e (evening dose).

    Measured: 7 days

  2. Tmax D1

    Time of the maximum measured plasma concentration on Day 1 over the morning 12-hour dosing interval on Day 1.

    Measured: 1 day

  3. AR Treatment R

    For Treatment R (reference products), the ratio of accumulation over the morning 12-hour dosing interval on Day 7 compared the morning 12-hour dosing interval on Day 1 will be determined by the formula, (AUC0-12,D7 / AUC0-12,D1).

    Measured: 7 days

  4. AR Treatment T

    For Treatment T (PrimeC), the ratio of accumulation over the morning 12-hour dosing interval on Day 7 compared the morning 12-hour dosing interval on Day 1 will be determined by the formula, (AUC0-12,D7 / AUC0-12,D1).

    Measured: 7 days

  5. Cav D7

    Average measured plasma concentration over the morning 12-hour dosing interval on Day 7.

    Measured: 7 days

  6. Cmin D7

    Minimum measured plasma concentration over the morning 12-hour dosing interval on Day 7.

    Measured: 7 days

  7. Ctrough D7

    Measured plasma concentration at the end of the morning dosing interval on Day 7.

    Measured: 7 days

  8. Tmax D7

    Time of the maximum measured plasma concentration over the morning 12-hour dosing interval on Day 7.

    Measured: 7 days

  9. λz

    First order rate constant associated with the terminal (log-linear) portion of the curve following the last dose administered on the morning of Day 7.

    Measured: 7 days

  10. t½

    The terminal half-life following the last dose administered on the morning of Day 7

    Measured: 7 days

  11. Percent Fluctuation

    Percent fluctuation over the morning 12-hour dosing interval on Day 7

    Measured: 7 days

  12. Percent Swing

    Percent swing over the morning 12-hour dosing interval on Day 7

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2022
  2. Study start26 Jul 2022
  3. Primary completion19 Aug 2022
  4. Study completion20 Oct 2022

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05436678
Sponsor's protocol ID
NST-PK-003
Status last verified
Jun 2022
First submitted
22 Jun 2022
Last updated
8 Feb 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PrimeC 748 mg, Ciprofloxacin 750 MG and Celecoxib 200mg in people with Pharmacokinetics, run by NeuroSense Therapeutics Ltd. 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 24 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 8 Feb 2023. 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?

Cmax D1 (time frame: 1 day). The study lists 4 primary outcomes in all. 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 NCT05436678.

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 8 Feb 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in