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NCT07570121 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics and Placental Transfer of Caffeine
A Phase 1 study, sponsored by Indiana University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT07570121: Recruiting Phase 1 study, sponsored by Indiana University.
NCT07570121 is a Phase 1 study that is actively recruiting participants, run by Indiana University. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07570121, a Phase 1 study, is actively recruiting participants, sponsored by Indiana University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The goal of this study is to learn how a pregnant person's body processes caffeine and how much caffeine crosses the placenta to the baby. A small dose of caffeine will be given to each pregnant participant before delivery. Blood will be drawn to measure caffeine levels in the pregnant mother. Blood will also be taken from the placenta and from the newborn to measure caffeine levels. This data will be used to form a computer model of the metabolism of caffeine during pregnancy.
Primary Outcome
Caffeine and primary metabolite concentrations will be determined in maternal plasma samples. Caffeine, paraxanthine, theophylline, and theobromine will be analyzed by HPLC-MS/MS (Sciex 6500) by the Indiana University Simon Comprehensive Cancer Center (IUSCCC)Clinical Pharmacology Analytical Core Laboratory. Pharmacokinetic modeling will be supported by the Indiana Clinical and Translational Sciences Institute Pharmacometric Modeling and Simulation Program. This model will be utilized to predict
Interventions
- DRUG Caffeine citrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
What NCT07570121 shows while recruiting
NCT07570121 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which Caffeine citrate is the first listed.
NCT07570121 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07570121 about?
NCT07570121 is a clinical study titled "Pharmacokinetics and Placental Transfer of Caffeine". The goal of this study is to learn how a pregnant person's body processes caffeine and how much caffeine crosses the placenta to the baby. A small dose of caffeine will be given to each pregnant participant before delivery. Blood will be drawn to measure caffeine levels in the pregnant mother. Blood...
What is the current status of trial NCT07570121?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2026-06-01. Estimated completion is 2027-06.
What interventions are being tested in trial NCT07570121?
The interventions under investigation include: Caffeine citrate (DRUG).
Who is sponsoring clinical trial NCT07570121?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07570121's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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