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NCT02475876 · ClinicalTrials.gov registry record · Phase 1
PK of Clindamycin and Trimethoprim-sulfamethoxazole in Infants and Children
A Phase 1 study, sponsored by Michael Cohen-Wolkowiez.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT02475876 is a Phase 1 study that has completed, run by Michael Cohen-Wolkowiez. The registered enrollment target is 51 participants.
The verdict
NCT02475876, a Phase 1 study, has completed, sponsored by Michael Cohen-Wolkowiez.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
Developmental changes in physiology during childhood influence drug dosing. Failure to account for these changes leads to improper dosing, which is associated with decreased drug efficacy and safety in children. Population physiologically-based pharmacokinetic (PBPK) modeling offers the opportunity to predict optimal drug dosing based on physiologic parameters adjusted for developmental changes. PBPK models are mathematical constructs that incorporate physiologic processes with drug characteristics and genetic variances to characterize the dose-exposure relationship across the age continuum. These models integrate drug-specific (e.g., metabolism, protein binding) and systems-specific (e.g., organ size, blood flow) information to predict the effect of different factors (e.g., age, genetic variants, disease) on drug exposure. By accounting for these factors and using data from clinical trials to confirm the modeling, PBPK models can reduce the number of children needed for clinical trials while maximizing dose-based efficacy and safety. This trial will evaluate a platform to prospectively validate population PBPK models in children. The study drugs, clindamycin and Bactrim (aka TMP-SMX), are ideal candidates to evaluate population PBPK models in children due to their differing physico-chemical properties and elimination pathways. In addition, a trial of clindamycin and TMP-SMX has broad clinical applicability, as both drugs are among the most commonly used agents to treat gram-positive infections in infants and children.
Interventions
- DRUG Clindamycin
- DRUG trimethoprim-sulfamethoxazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2015-11 |
| Est. Completion | 2020-06-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02475876
The ClinicalTrials.gov registry entry for NCT02475876 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Michael Cohen-Wolkowiez, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Clindamycin is the first listed.
NCT02475876 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02475876 about?
NCT02475876 is a clinical study titled "PK of Clindamycin and Trimethoprim-sulfamethoxazole in Infants and Children". Developmental changes in physiology during childhood influence drug dosing. Failure to account for these changes leads to improper dosing, which is associated with decreased drug efficacy and safety in children. Population physiologically-based pharmacokinetic (PBPK) modeling offers the opportunity ...
What is the current status of trial NCT02475876?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2015-11. Estimated completion is 2020-06-30.
What interventions are being tested in trial NCT02475876?
The interventions under investigation include: Clindamycin (DRUG), trimethoprim-sulfamethoxazole (DRUG).
Who is sponsoring clinical trial NCT02475876?
This trial is sponsored by Michael Cohen-Wolkowiez, which has 5 total clinical trials registered on ClinicalTrials.gov.
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