HealthyPhase 1NCT04147260

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

A Phase 1 study testing BI 730357 and Ciprofloxacin in people with Healthy, run by Boehringer Ingelheim at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the photosensitivity potential of BI 730357 Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 730357 and Ciprofloxacin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 85 participants
Where: 1 siteUnited States
Study dates: 6 Nov 2019to 9 Sep 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

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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

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

TKL Research, Inc.
Fair Lawn, New Jersey, 07410

Other trials in United States

About this study

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

To evaluate the photosensitivity potential of BI 730357

Conditions: Healthy
Being tested: BI 730357, Placebo to match BI 730357, Ciprofloxacin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 730357Drug
Film-coated tablet
Placebo to match BI 730357Drug
Film-coated tablet
CiprofloxacinDrug
Film-coated tablet

Study groups in NCT04147260
Study group	Role	What they receive
BI 730357 low dose	Experimental	Not described Receives: Drug: BI 730357
Ciprofloxacin	Active comparator	Not described Receives: Drug: Ciprofloxacin
BI 730357 high dose	Experimental	Not described Receives: Drug: BI 730357
Placebo	Placebo comparator	Not described Receives: Drug: Placebo to match BI 730357

What is being measured

The primary outcome is the main question the study is designed to answer.

Photosensitivity Index at 24 Hours Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)
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.
Measured: At 24 hours after irradiation on Day 8
Photosensitivity Index at 24 Hours Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)
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.
Measured: At 24 hours after irradiation on Day 8

Secondary outcomes (10)

Photosensitivity Index (PI) at 10 Minutes Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)
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.
Measured: At 10 minutes after irradiation on Day 8
Photosensitivity Index (PI) at 10 Minutes Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)
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.
Measured: At 10 minutes after irradiation on Day 8
Photosensitivity Index (PI) at 1 Hour Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)
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.
Measured: At 1 hour after irradiation on Day 8
Photosensitivity Index (PI) at 1 Hour Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)
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.
Measured: At 1 hour after irradiation on Day 8
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)
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.
Measured: At baseline (Day -2) and at 10 minutes after irradiation on Day 8
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)
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.
Measured: At baseline (Day -2) and at 10 minutes after irradiation on Day 8
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)
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.
Measured: At baseline (Day -2) and at 1 hour after irradiation on Day 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)
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.
Measured: At baseline (Day -2) and at 1 hour after irradiation on Day 8
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)
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.
Measured: At baseline (Day -2) and at 24 hours after irradiation on Day 8
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)
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.
Measured: At baseline and at 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Nov 20199 Sep 2020

First posted1 Nov 2019
Study start6 Nov 2019
Primary completion9 Sep 2020
Study completion9 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04147260
Sponsor's protocol ID: 1407-0037
Status last verified: Aug 2022
First submitted: 30 Oct 2019
Last updated: 17 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1\. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Partially-blind, Randomized, Parallel Group, Placebo and Active Comparator-controlled Phase I Clinical Trial to Evaluate the Photosensitivity Potential of BI 730357
ClinicalTrials.gov ID: NCT04147260
Acronym / sponsor ID: 1407-0037
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 85 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 6 Nov 2019 (actual)
Primary completion: 9 Sep 2020 (actual)
Study completion: 9 Sep 2020 (actual)
First posted: 1 Nov 2019 (actual)
Results: Posted 17 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the photosensitivity potential of BI 730357

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
BI 730357 low dose	Experimental	Drug: BI 730357
Ciprofloxacin	Active comparator	Drug: Ciprofloxacin
BI 730357 high dose	Experimental	Drug: BI 730357
Placebo	Placebo comparator	Drug: Placebo to match BI 730357

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

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:
No ultraviolet exposure of the test areas 4 weeks prior to baseline photo testing

Key exclusion criteria (24 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BI 730357Film-coated tablet	Drug	BI 730357 high dose, BI 730357 low dose
Placebo to match BI 730357Film-coated tablet	Drug	Placebo
CiprofloxacinFilm-coated tablet	Drug	Ciprofloxacin

Primary outcome

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.
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.

10 secondary outcomes

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) 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) 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) 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
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
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
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
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
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
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

Results and safety

Results posted to the registry on 17 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo QD	9	8
400 mg QD BI 730357	27	27
Placebo BID	9	7
300 mg BID BI 730357	28	25
500 mg Ciprofloxacin (Active Comparator)	12	12

Primary outcome: 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. Least squares mean (95% Confidence Interval). Unit: Unitless

Measure	Placebo QD n = 8	400 mg QD BI 730357 n = 27	Placebo BID n = 7	300 mg BID BI 730357 n = 25	500 mg Ciprofloxacin (Active Comparator) n = 12
Value	0.93 (0.80 to 1.05)	1.01 (0.95 to 1.08)	1.00 (0.88 to 1.12)	1.04 (0.98 to 1.11)	1.08 (0.98 to 1.17)

Placebo QD vs 400 mg QD BI 730357: Mean Difference (Final Values): 0.09 (90% CI -0.03 to 0.20), Linear mixed model
Placebo BID vs 300 mg BID BI 730357: Mean Difference (Final Values): 0.04 (90% CI -0.07 to 0.16), Linear mixed model
300 mg BID BI 730357 vs 500 mg Ciprofloxacin (Active Comparator): Mean Difference (Final Values): -0.03 (90% CI -0.14 to 0.08), p = 0.572, Linear mixed model

Population analysed: Full Analysis Set (FAS): This set included all subjects in the treated set (TS) who provided at least 1 photosensitivity endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of photosensitivity.

Primary outcome: 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. Least squares mean (95% Confidence Interval). Unit: Unitless

Measure	Placebo QD n = 8	400 mg QD BI 730357 n = 27	Placebo BID n = 7	300 mg BID BI 730357 n = 25	500 mg Ciprofloxacin (Active Comparator) n = 12
Value	0.94 (0.67 to 1.21)	1.17 (1.02 to 1.32)	1.00 (0.78 to 1.22)	1.01 (0.89 to 1.13)	1.52 (1.35 to 1.69)

Placebo QD vs 400 mg QD BI 730357: Mean Difference (Final Values): 0.23 (90% CI -0.02 to 0.49), Linear mixed model
Placebo BID vs 300 mg BID BI 730357: Mean Difference (Final Values): 0.01 (90% CI -0.20 to 0.22), Linear mixed model
300 mg BID BI 730357 vs 500 mg Ciprofloxacin (Active Comparator): Mean Difference (Final Values): -0.51 (90% CI -0.72 to -0.31), p <0.001, Linear mixed model

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of treatment until end of the 7 day follow up period, 15 days in total.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo QD/BID	0 of 18 (0%)	7 of 18 (38.9%)	0 of 18
400 mg QD BI 730357	0 of 27 (0%)	9 of 27 (33.3%)	0 of 27
300 mg BID BI 730357	0 of 28 (0%)	11 of 28 (39.3%)	0 of 28
500 mg BID Ciprofloxacin (Active Comparator))	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 730357 and Ciprofloxacin in people with Healthy, run by Boehringer Ingelheim at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04147260.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.