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NCT05232461 · ClinicalTrials.gov registry record · Phase 1
A Pilot Study to Evaluate the PK Profile of PrimeC-ER Tablets in Healthy Adult Subjects
A Phase 1 study of Pharmacokinetics, sponsored by NeuroSense Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT05232461: Completed Phase 1 study of Pharmacokinetics, sponsored by NeuroSense Therapeutics.
NCT05232461 is a Phase 1 study of Pharmacokinetics that has completed, run by NeuroSense Therapeutics. The registered enrollment target is 12 participants, below the 62-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05232461, a Phase 1 study of Pharmacokinetics, has completed, sponsored by NeuroSense Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label, randomized, single-dose, three treatment, three-period crossover study comparing the test and reference products under fasted or fed conditions (as applicable). In one period of the study, PrimeC-ER tablets will be administered to subjects following an overnight fast of at least 10 hours. In a second period of the study, PrimeC-ER tablets will be administered to subjects at 30 minutes following the start of a standardized high-fat, high-calorie breakfast that was preceded by an overnight fast of at least 10 hours. In a third period of the study, a single 750 mg dose of ciprofloxacin and a single 200 mg dose of celecoxib will be co-administered to subjects following an overnight fast of at least 10 hours. The order of administration will follow a six-sequence randomization schedule. Blood samples will be collected at pre-dose and at intervals over 48 hours after dosing in each study period. Subjects will be confined at the clinical facility from at least 10.5 hours before dosing until 48 hours after dosing in each study period. The interval between doses will be at least 7 days. Subjects will return to the clinical facility 7 days (± 1 day) after the last study drug administration for an end-of study follow-up visit.
Primary Outcome
AUC is tested in order to assess the effect of food on the bioavailability of PrimeC-ER Tablets (748 mg) in healthy adult male and female subjects, and in order to evaluate the comparative bioavailability of PrimeC-ER Tablets (748 mg) relative to a 750 mg dose of ciprofloxacin tablets and a 200 mg dose of celecoxib capsules, when co-administered, under fasted conditions in healthy adult male and female subjects.
Conditions Studied
Interventions
- DRUG PrimeC-ER 748 mg
- DRUG Ciprofloxacin 750 MG
- DRUG Celecoxib 200mg
Study Locations (1)
North Dakota
- Novum - Fargo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-04-08 |
| Est. Completion | 2022-08-30 |
| Phase | Phase 1 |
What the finished NCT05232461 record still lists
NCT05232461 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 62-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Pharmacokinetics appearing as the primary indexed condition, and to 3 interventions - of which PrimeC-ER 748 mg is the first listed.
NCT05232461 reports a single indexed study location in North Dakota.
Frequently Asked Questions
What is clinical trial NCT05232461 about?
NCT05232461 is a clinical study titled "A Pilot Study to Evaluate the PK Profile of PrimeC-ER Tablets in Healthy Adult Subjects". This is an open-label, randomized, single-dose, three treatment, three-period crossover study comparing the test and reference products under fasted or fed conditions (as applicable). In one period of the study, PrimeC-ER tablets will be administered to subjects following an overnight fast of at lea...
What is the current status of trial NCT05232461?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2022-04-08. Estimated completion is 2022-08-30.
What conditions does trial NCT05232461 study?
This clinical trial studies the following conditions: Pharmacokinetics.
What interventions are being tested in trial NCT05232461?
The interventions under investigation include: PrimeC-ER 748 mg (DRUG), Ciprofloxacin 750 MG (DRUG), Celecoxib 200mg (DRUG).
Who is sponsoring clinical trial NCT05232461?
This trial is sponsored by NeuroSense Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05232461 being conducted?
This trial has 1 study location across North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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