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Completed

NCT Number: NCT04147260

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

To evaluate the photosensitivity potential of BI 730357

Completed

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

TKL Research, Inc.

Fair Lawn, New Jersey, 07410, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 disorders or any evidence of a concomitant disease judged as clinically relevant by the Investigator.
  • Major surgery (major according to the investigator's assessment) performed within 10 weeks prior to randomisation or planned within 2 months after screening.
  • Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix.
  • Active skin disorders on the back where photosensitivity testing will be performed.
  • Subjects who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
  • Subjects not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the subject an unreliable trial participant).
  • Currently enrolled in another investigational device or drug trial, or less than 30 days (or 5 half-lives (whichever longer)) since ending another investigational drug trial.
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
  • History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients).
  • History of hypersensitivity to ciprofloxacin, any member of the quinolone class of antibacterials.
  • History of hypersensitivity to sunlight or artificial source of intense light, especially UV light.
  • Chronic or acute infections which are of relevance in the opinion of the Investigator.
  • Positive result for HIV, HBV, and hepatitis C (Hep C) at screening.
  • History of TB or positive finding in IGRA.
  • Unwillingness/inability to refrain from intake of alcoholic beverages from 48 hours prior to the trial medication administration and until Day 7 post trial medication administration.
  • Positive drug screening.
  • Blood donation of more than 500 mL within 30 days prior to administration of trial medication or intended donation during the trial.
  • Intention to perform excessive physical activities within 4 days prior to administration of trial medication or contact sport during the entire trial and unwilling to avoid vigorous exercise for 7 days post dosing.
  • Inability to comply with dietary regimen of trial site.
  • Unwillingness to adhere to the rules of UV-light protection
  • Received a live vaccination within 12 weeks prior to randomisation (visit 2), or any plan to receive a live vaccination during the conduct of this trial.
  • Subjects with known prolongation of the QT interval, risk factors for QT prolongation or torsade de pointes.

Treatment and study plan

BI 730357

Drug

Film-coated tablet

Placebo to match BI 730357

Drug

Film-coated tablet

Ciprofloxacin

Drug

Film-coated tablet

Primary outcomes

  1. Photosensitivity Index at 24 Hours Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)

    Time frame: At 24 hours after irradiation on Day 8

    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 in mJ for UVB/UVA).

    Subjects were exposed to a series of 6 graded full range solar UVB/UVA exposures, each 25% greater than the previous dose.

    Light exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 24 hours after irradiation.

  2. Photosensitivity Index at 24 Hours Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)

    Time frame: At 24 hours after irradiation on Day 8

    Photosensitivity index (PI) under condition 2 (C2)(i.e., UVA only (320 to 400 nm, UVB content <0.03%), simulating indoor exposure behind window glass with a secondary assessment of erythema and local skin reactions at 25 Joules per centimetres-2 (J cm-2) (assessed in mw/cm2)), 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[Joules (J)]/MEDbaseline[J]) and hence unitless.

    MED was defined as lowest dose that produced uniform darkening (C2) (assessed in J for UVA).

    Subjects were exposed to series of 6 graded full range solar UVA exposures (C2), each 25% greater than the previous dose.

    Light exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 24 hours after irradiation.

Secondary outcomes

  1. Photosensitivity Index (PI) at 10 Minutes Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)

    Time frame: At 10 minutes after irradiation on Day 8

    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. 10 minutes)(i.e., MEDon-drug[millijoules (mJ)]/MEDbaseline[mJ]) and was hence unitless.

    MED was defined as lowest dose that produced uniform redness (C1) (assessed in mJ for UVB/UVA).

    Subjects were exposed to a series of 6 graded full range solar UVB/UVA exposures, each 25% greater than the previous dose.

    Light exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 10 minutes after irradiation.

  2. Photosensitivity Index (PI) at 10 Minutes Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)

    Time frame: At 10 minutes after irradiation on Day 8

    Photosensitivity index (PI) under condition 2 (C2)(i.e., UVA only (320 to 400 nm, UVB content <0.03%), simulating indoor exposure behind window glass with secondary assessment of erythema and local skin reactions at 25 Joules centimetres-2 (J cm-2) (assessed in mw/cm2)), was defined as ratio of precise Minimum erythema dose (MED)baseline to MEDon-drug at each respective post irradiation time point (i.e. 10 minutes)(i.e., MEDon-drug[Joules (J)]/MEDbaseline[J]) and was hence unitless.

    MED defined as lowest dose that produced uniform darkening (C2) (assessed in J for UVA).

    Subjects were exposed to series of 6 graded full range solar UVA exposures (C2), each 25% greater than the previous dose.

    Light exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 10 minutes after irradiation.

  3. Photosensitivity Index (PI) at 1 Hour Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)

    Time frame: At 1 hour after irradiation on Day 8

    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. 1 hour)(i.e., MEDon-drug[millijoules (mJ)]/MEDbaseline[mJ]) and was hence unitless.

    MED was defined as lowest dose that produced uniform redness (C1) (assessed in mJ for UVB/UVA).

    Subjects were exposed to a series of 6 graded full range solar UVB/UVA exposures, each 25% greater than the previous dose.

    Light exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 1 hour after irradiation.

  4. Photosensitivity Index (PI) at 1 Hour Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)

    Time frame: At 1 hour after irradiation on Day 8

    Photosensitivity index (PI) under condition 2 (C2)(i.e., UVA only (320 to 400 nm, UVB content <0.03%), simulating indoor exposure behind window glass with a secondary assessment of erythema and local skin reactions at 25 Joules centimetres-2 (J cm-2) (assessed in mw/cm2)), defined as ratio of precise Minimum erythema dose (MED)baseline to MEDon-drug at each respective post irradiation time point (i.e. 1 hour)(i.e. MEDon-drug[Joules (J)]/MEDbaseline[J]) and was hence unitless.

    MED defined as lowest dose that produced uniform darkening (C2) (assessed in J for UVA).

    Subjects were exposed to series of 6 graded full range solar UVA only exposures (C2), each 25% greater than the previous dose.

    Light exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 1 hour after irradiation.

  5. Minimum Erythema Dose (MED) Percent Change From Baseline at 10 Minutes Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)

    Time frame: At baseline (Day -2) and at 10 minutes after irradiation on Day 8

    The Minimum erythema dose (MED) percent change from baseline at 10 minutes was calculated as follows: % change = ([MEDon-drug - MEDbaseline]/ MEDbaseline) x 100.

    MED 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 lowest dose that produced uniform redness (assessed in mJ for UVB/UVA).

    Subjects were exposed to a series of 6 graded full range solar UVB/UVA exposures, each 25% greater than the previous dose.

    Light exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 10 minutes after irradiation.

  6. Minimum Erythema Dose (MED) Percent Change From Baseline at 10 Minutes Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)

    Time frame: At baseline (Day -2) and at 10 minutes after irradiation on Day 8

    The Minimum erythema dose (MED) percent change from baseline at 10 minutes was calculated as follows: % change = ([MEDon-drug - MEDbaseline]/ MEDbaseline) x 100.

    MED under condition 2 (C2)(i.e., UVA only (320 to 400 nm, UVB content <0.03%), simulating indoor exposure behind window glass with a secondary assessment of erythema and local skin reactions at 25 Joules centimetres-2 (J cm-2) (assessed in mw/cm2)), was defined as lowest dose that produced uniform darkening (assessed in J for UVA).

    Subjects were exposed to a series of 6 graded full range solar UVA only exposures, each 25% greater than the previous dose.

    Light exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 10 minutes after irradiation.

  7. Minimum Erythema Dose (MED) Percent Change From Baseline at 1 Hour Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)

    Time frame: At baseline (Day -2) and at 1 hour after irradiation on Day 8

    The Minimum erythema dose (MED) percent change from baseline at 1 hour was calculated as follows: % change = ([MEDon-drug - MEDbaseline]/ MEDbaseline) x 100.

    MED 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 lowest dose that produced uniform redness (assessed in mJ for UVB/UVA).

    Subjects were exposed to a series of 6 graded full range solar UVB/UVA exposures, each 25% greater than the previous dose.

    Light exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 1 hour after irradiation.

  8. Minimum Erythema Dose (MED) Percent Change From Baseline at 1 Hour Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)

    Time frame: At baseline (Day -2) and at 1 hour after irradiation on Day 8

    The Minimum erythema dose (MED) percent change from baseline at 1 hour was calculated as follows: % change = ([MEDon-drug - MEDbaseline]/ MEDbaseline) x 100.

    MED under condition 2 (C2)(i.e., UVA only (320 to 400 nm, UVB content <0.03%), simulating indoor exposure behind window glass with a secondary assessment of erythema and local skin reactions at 25 Joules centimetres-2 (J cm-2) (assessed in mw/cm2)), was defined as lowest dose that produced uniform darkening (assessed in J for UVA).

    Subjects were exposed to a series of 6 graded full range solar UVA only exposures, each 25% greater than the previous dose.

    Light exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 1 hour after irradiation.

  9. Minimum Erythema Dose (MED) Percent Change From Baseline at 24 Hours Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)

    Time frame: At baseline (Day -2) and at 24 hours after irradiation on Day 8

    The Minimum erythema dose (MED) percent change from baseline at 24 hours was calculated as follows: % change = ([MEDon-drug - MEDbaseline]/ MEDbaseline) x 100.

    MED 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 lowest dose that produced uniform redness (assessed in mJ for UVB/UVA).

    Subjects were exposed to a series of 6 graded full range solar UVB/UVA exposures, each 25% greater than the previous dose.

    Light exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 24 hours after irradiation.

  10. Minimum Erythema Dose (MED) Percent Change From Baseline at 24 Hours Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)

    Time frame: At baseline and at 24 hours

    The Minimum erythema dose (MED) percent change from baseline at 24 hours was calculated as follows: % change = ([MEDon-drug - MEDbaseline]/ MEDbaseline) x 100.

    MED under condition 2 (C2)(i.e., UVA only (320 to 400 nm, UVB content <0.03%), simulating indoor exposure behind window glass with a secondary assessment of erythema and local skin reactions at 25 Joules centimetres-2 (J cm-2) (assessed in mw/cm2)), was defined as lowest dose that produced uniform darkening (assessed in J for UVA).

    Subjects were exposed to a series of 6 graded full range solar UVA only exposures, each 25% greater than the previous dose.

    Light exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 24 hours after irradiation.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Partially-blind, Randomized, Parallel Group, Placebo and Active Comparator-controlled Phase I Clinical Trial to Evaluate the Photosensitivity Potential of BI 730357

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 1, 2019
Registry last updated
Jul 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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