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NCT01458028 · ClinicalTrials.gov registry record · Phase 1
Age and Gender Effects on the Pharmacokinetics of BAY85-3934
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT01458028: Completed Phase 1 study, sponsored by Bayer.
NCT01458028 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01458028, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
Single dose study of BAY85-3934 compared to placebo in young/elderly male and female healthy subjects. The main focus of the study is to determine if the pharmacokinetics (drug levels in blood) of BAY85-3934 is similar or not in the four subject groups. Qualifying subjects will be dosed with a single tablet of BAY85-3934 (or placebo) and blood will be drawn over 4 days. The safety and tolerability of BAY85-3934 compared to placebo will also be evaluated over the 5 days of the study.
Interventions
- DRUG Placebo
- DRUG BAY85-3934
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2011-09 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
What the finished NCT01458028 record still lists
NCT01458028 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01458028 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01458028 about?
NCT01458028 is a clinical study titled "Age and Gender Effects on the Pharmacokinetics of BAY85-3934". Single dose study of BAY85-3934 compared to placebo in young/elderly male and female healthy subjects. The main focus of the study is to determine if the pharmacokinetics (drug levels in blood) of BAY85-3934 is similar or not in the four subject groups. Qualifying subjects will be dosed with a singl...
What is the current status of trial NCT01458028?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2011-09. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01458028?
The interventions under investigation include: Placebo (DRUG), BAY85-3934 (DRUG).
Who is sponsoring clinical trial NCT01458028?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01458028's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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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