Evaluation of Photosafety of BI 730357 Compared to Placebo and the Known Photosensitizing Agent C… (NCT04147260) | Clinical Trial Compass
CompletedPhase 1
Evaluation of Photosafety of BI 730357 Compared to Placebo and the Known Photosensitizing Agent Ciprofloxacin
United States85 participantsStarted 2019-11-06
Plain-language summary
To evaluate the photosensitivity potential of BI 730357
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy male and female subjects according to the assessment of the Investigator, based on a complete medical history, physical examination (including dermatological skin type assessment), vital signs (blood pressure, pulse rate), 12-lead ECG, and clinical laboratory tests
* 18 to 55 years old
* BMI 18 to 35 kg/m (incl.)
* Fitzpatrick skin type I, II, or III:
* I Always burns easily, never tans
* II Always burns easily, tans minimally
* III Burns moderately, tans gradually
* No ultraviolet exposure of the test areas 4 weeks prior to baseline photo testing
* Normal skin response during preliminary photo testing.
* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
* Women of childbearing potential (WOCBP)1 must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information
Exclusion Criteria:
* Any finding in the medical examination (including blood pressure, pulse rate or ECG) deviating from normal and judged as clinically relevant by the Investigator.
* Any laboratory value outside the reference range that the Investigator considers to be of clinical relevance.
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal dis…
What they're measuring
1
Photosensitivity Index at 24 Hours Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)
Timeframe: At 24 hours after irradiation on Day 8
2
Photosensitivity Index at 24 Hours Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)