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

NCT05436678 | Completed Phase 1 FDA Drug

• 1 other identifier: NST-PK-003
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• Cmax D1

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

  1 day

• Cmax D7

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

  7 days

• 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.

  1 day

• 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.

  7 days

Secondary Outcomes (12)

• Cpre Dx

  7 days

• Tmax D1

  1 day

• AR Treatment R

  7 days

• AR Treatment T

  7 days

• Cav D7

  7 days

Study Arms (2)

PrimeC

ACTIVE COMPARATOR

2 PrimeC tablets (total single dose 748 mg) twice daily for 6.5 days following a meal

Drug: PrimeC 748 mg

Marketed ciprofloxacin and celecoxib

ACTIVE COMPARATOR

750 mg of ciprofloxacin and 200 mg of celecoxib, co-administered twice daily for 6.5 days following a meal

Drug: Ciprofloxacin 750 MG; Drug: Celecoxib 200mg

Interventions

PrimeC 748 mg DRUG

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

PrimeC

Ciprofloxacin 750 MG DRUG

Ciprofloxacin

Marketed ciprofloxacin and celecoxib

Celecoxib 200mg DRUG

Celecoxib

Marketed ciprofloxacin and celecoxib

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• NeuroSense Therapeutics Ltd.: lead

Study Sites (1)

Novum

Las Vegas, Nevada, 89121, United States

Location

MeSH Terms

Interventions

Ciprofloxacin; Celecoxib

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 29, 2022
• Study Start: July 26, 2022
• Primary Completion: August 19, 2022
• Study Completion: October 20, 2022
• Last Updated: February 8, 2023

Record last verified: 2022-06

Locations

US (1)