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NCT04147260 · ClinicalTrials.gov registry record · Phase 1

Evaluation of Photosafety of BI 730357 Compared to Placebo and the Known Photosensitizing Agent Ciprofloxacin

A Phase 1 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 1
Development phase
85
Enrollment target

NCT04147260: Completed Phase 1 study, sponsored by Boehringer Ingelheim.

NCT04147260 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 85 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04147260, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 1
Development phase
85 participants
Enrollment target

Study Summary

To evaluate the photosensitivity potential of BI 730357

Primary Outcome

Photosensitivity index (PI) under condition 1 (C1)(i.e., under full range solar UVB/UVA (290 to 400 nm, UBV content \~10%), simulating midday summer outdoor sun exposure (assessed in μw/cm2)), was defined as ratio of the precise Minimum erythema dose (MED)baseline to MEDon-drug at each respective post irradiation time point (i.e. 24 hours)(i.e., MEDon-drug\[millijoules (mJ)\]/MEDbaseline\[mJ\]) and was hence unitless. MED was defined as lowest dose that produced uniform redness (C1) (assessed i

Interventions

  • DRUG Ciprofloxacin
  • DRUG BI 730357
  • DRUG Placebo to match BI 730357

Trial Details

FieldValue
Enrollment Target 85 participants
Start Date 2019-11-06
Est. Completion 2020-09-09
Phase Phase 1
Boehringer Ingelheim

515 total trials

What the finished NCT04147260 record still lists

NCT04147260 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher).

The record links to 0 conditions, and to 3 interventions - of which Ciprofloxacin is the first listed.

NCT04147260 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04147260 about?

NCT04147260 is a clinical study titled "Evaluation of Photosafety of BI 730357 Compared to Placebo and the Known Photosensitizing Agent Ciprofloxacin". To evaluate the photosensitivity potential of BI 730357

What is the current status of trial NCT04147260?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2019-11-06. Estimated completion is 2020-09-09.

What interventions are being tested in trial NCT04147260?

The interventions under investigation include: Ciprofloxacin (DRUG), BI 730357 (DRUG), Placebo to match BI 730357 (DRUG).

Who is sponsoring clinical trial NCT04147260?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04147260's enrollment target sits among peer trials

85 656th of 2000 higher than 1,342 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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Source: ClinicalTrials.gov NCT04147260, the US trial registry maintained by the National Library of Medicine. NCT04147260 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.