Trial Outcomes & Findings for Evaluation of Photosafety of BI 730357 Compared to Placebo and the Known Photosensitizing Agent Ciprofloxacin (NCT NCT04147260)

Last Updated: 2023-07-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

85 participants

Primary outcome timeframe

At 24 hours after irradiation on Day 8

Results posted on

2023-07-17

Participant Flow

This is a partially blind, randomized, parallel group, placebo, and active comparator controlled Phase I clinical trial in healthy male and female subjects to evaluate the photosensitivity potential of BI 730357 compared with placebo and active comparator, and to assess the relationship between the photosensitivity response and pharmacokinetics of BI 730357.

All subjects were screened for eligibility to participants in the trial. Subjects attended specialist sites which would then ensure that they met all strictly implemented inclusion/exclusion criteria. Subjects were not to be assigned to treatment groups if any one of the specific entry criteria were violated.

Participant milestones

Participant milestones
Measure	Placebo QD Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.	400 mg QD BI 730357 Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	Placebo BID Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	300 mg BID BI 730357 Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	500 mg Ciprofloxacin (Active Comparator) Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.
Overall Study STARTED	9	27	9	28	12
Overall Study COMPLETED	8	27	7	25	12
Overall Study NOT COMPLETED	1	0	2	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo QD Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.	400 mg QD BI 730357 Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	Placebo BID Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	300 mg BID BI 730357 Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	500 mg Ciprofloxacin (Active Comparator) Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.
Overall Study Adverse Event	1	0	1	2	0
Overall Study Withdrawal by Subject	0	0	1	1	0

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo QD n=9 Participants Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.	400 mg QD BI 730357 n=27 Participants Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	Placebo BID n=9 Participants Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	300 mg BID BI 730357 n=28 Participants Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	500 mg Ciprofloxacin (Active Comparator) n=12 Participants Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	Total n=85 Participants Total of all reporting groups
Age, Continuous	43.0 Years STANDARD_DEVIATION 12.06 • n=9 Participants	37.0 Years STANDARD_DEVIATION 11.62 • n=27 Participants	40.1 Years STANDARD_DEVIATION 8.84 • n=9 Participants	39.7 Years STANDARD_DEVIATION 12.84 • n=28 Participants	40.7 Years STANDARD_DEVIATION 12.58 • n=12 Participants	39.4 Years STANDARD_DEVIATION 11.84 • n=85 Participants
Sex: Female, Male Female	4 Participants n=9 Participants	12 Participants n=27 Participants	6 Participants n=9 Participants	18 Participants n=28 Participants	3 Participants n=12 Participants	43 Participants n=85 Participants
Sex: Female, Male Male	5 Participants n=9 Participants	15 Participants n=27 Participants	3 Participants n=9 Participants	10 Participants n=28 Participants	9 Participants n=12 Participants	42 Participants n=85 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=9 Participants	14 Participants n=27 Participants	6 Participants n=9 Participants	12 Participants n=28 Participants	5 Participants n=12 Participants	41 Participants n=85 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=9 Participants	13 Participants n=27 Participants	3 Participants n=9 Participants	16 Participants n=28 Participants	7 Participants n=12 Participants	44 Participants n=85 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=9 Participants	0 Participants n=28 Participants	0 Participants n=12 Participants	0 Participants n=85 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=9 Participants	0 Participants n=28 Participants	0 Participants n=12 Participants	0 Participants n=85 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants	0 Participants n=27 Participants	1 Participants n=9 Participants	1 Participants n=28 Participants	0 Participants n=12 Participants	2 Participants n=85 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=27 Participants	1 Participants n=9 Participants	0 Participants n=28 Participants	0 Participants n=12 Participants	1 Participants n=85 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=9 Participants	0 Participants n=28 Participants	0 Participants n=12 Participants	0 Participants n=85 Participants
Race (NIH/OMB) White	9 Participants n=9 Participants	26 Participants n=27 Participants	7 Participants n=9 Participants	26 Participants n=28 Participants	12 Participants n=12 Participants	80 Participants n=85 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=9 Participants	0 Participants n=28 Participants	0 Participants n=12 Participants	0 Participants n=85 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	1 Participants n=27 Participants	0 Participants n=9 Participants	1 Participants n=28 Participants	0 Participants n=12 Participants	2 Participants n=85 Participants
Minimum Erythema Dose (MED) at baseline under condition 1	30.60 millijoules/squarecentimeter STANDARD_DEVIATION 6.328 • n=8 Participants • 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.	35.41 millijoules/squarecentimeter STANDARD_DEVIATION 11.892 • n=27 Participants • 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.	36.84 millijoules/squarecentimeter STANDARD_DEVIATION 7.910 • n=7 Participants • 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.	30.82 millijoules/squarecentimeter STANDARD_DEVIATION 12.163 • n=25 Participants • 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.	30.78 millijoules/squarecentimeter STANDARD_DEVIATION 12.280 • n=12 Participants • 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.	32.89 millijoules/squarecentimeter STANDARD_DEVIATION 11.34 • n=79 Participants • 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.
Minimum Erythema Dose (MED) at baseline under condition 2	21.60 Joules/squarecentimeter STANDARD_DEVIATION 4.04 • n=8 Participants • 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.	24.09 Joules/squarecentimeter STANDARD_DEVIATION 2.76 • n=27 Participants • 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.	25.10 Joules/squarecentimeter STANDARD_DEVIATION 0.00 • n=7 Participants • 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.	20.83 Joules/squarecentimeter STANDARD_DEVIATION 5.29 • n=25 Participants • 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.	22.58 Joules/squarecentimeter STANDARD_DEVIATION 4.64 • n=12 Participants • 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.	22.67 Joules/squarecentimeter STANDARD_DEVIATION 4.25 • n=79 Participants • 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

Timeframe: At 24 hours after irradiation on Day 8

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo QD n=8 Participants Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.	400 mg QD BI 730357 n=27 Participants Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	Placebo BID n=7 Participants Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	300 mg BID BI 730357 n=25 Participants Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	500 mg Ciprofloxacin (Active Comparator) n=12 Participants Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.
Photosensitivity Index at 24 Hours Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)	0.93 Unitless Interval 0.8 to 1.05	1.01 Unitless Interval 0.95 to 1.08	1.00 Unitless Interval 0.88 to 1.12	1.04 Unitless Interval 0.98 to 1.11	1.08 Unitless Interval 0.98 to 1.17

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo QD n=8 Participants Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.	400 mg QD BI 730357 n=27 Participants Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	Placebo BID n=7 Participants Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	300 mg BID BI 730357 n=25 Participants Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	500 mg Ciprofloxacin (Active Comparator) n=12 Participants Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.
Photosensitivity Index at 24 Hours Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)	0.94 Unitless Interval 0.67 to 1.21	1.17 Unitless Interval 1.02 to 1.32	1.00 Unitless Interval 0.78 to 1.22	1.01 Unitless Interval 0.89 to 1.13	1.52 Unitless Interval 1.35 to 1.69

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo QD n=8 Participants Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.	400 mg QD BI 730357 n=27 Participants Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	Placebo BID n=7 Participants Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	300 mg BID BI 730357 n=25 Participants Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	500 mg Ciprofloxacin (Active Comparator) n=12 Participants Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.
Photosensitivity Index (PI) at 10 Minutes Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)	0.98 Unitless Interval 0.9 to 1.05	1.00 Unitless Interval 0.96 to 1.04	1.00 Unitless Interval 0.82 to 1.18	1.06 Unitless Interval 0.97 to 1.16	1.00 Unitless Interval 0.94 to 1.06

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo QD n=8 Participants Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.	400 mg QD BI 730357 n=27 Participants Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	Placebo BID n=7 Participants Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	300 mg BID BI 730357 n=25 Participants Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	500 mg Ciprofloxacin (Active Comparator) n=12 Participants Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.
Photosensitivity Index (PI) at 10 Minutes Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)	1.02 Unitless Interval 0.76 to 1.29	1.13 Unitless Interval 0.99 to 1.28	1.00 Unitless Interval 0.67 to 1.33	1.29 Unitless Interval 1.12 to 1.46	1.03 Unitless Interval 0.81 to 1.25

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo QD n=8 Participants Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.	400 mg QD BI 730357 n=27 Participants Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	Placebo BID n=7 Participants Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	300 mg BID BI 730357 n=25 Participants Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	500 mg Ciprofloxacin (Active Comparator) n=12 Participants Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.
Photosensitivity Index (PI) at 1 Hour Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)	1.07 Unitless Interval 0.99 to 1.15	0.99 Unitless Interval 0.95 to 1.03	1.04 Unitless Interval 0.85 to 1.22	1.08 Unitless Interval 0.99 to 1.18	1.00 Unitless Interval 0.94 to 1.06

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo QD n=8 Participants Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.	400 mg QD BI 730357 n=27 Participants Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	Placebo BID n=7 Participants Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	300 mg BID BI 730357 n=25 Participants Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	500 mg Ciprofloxacin (Active Comparator) n=12 Participants Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.
Photosensitivity Index (PI) at 1 Hour Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)	0.91 Unitless Interval 0.68 to 1.14	1.22 Unitless Interval 1.1 to 1.34	1.00 Unitless Interval 0.76 to 1.24	1.19 Unitless Interval 1.06 to 1.32	1.06 Unitless Interval 0.87 to 1.24

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo QD n=8 Participants Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.	400 mg QD BI 730357 n=27 Participants Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	Placebo BID n=7 Participants Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	300 mg BID BI 730357 n=25 Participants Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	500 mg Ciprofloxacin (Active Comparator) n=12 Participants Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.
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)	3.12 Percent change Interval -4.88 to 11.12	1.68 Percent change Interval -2.68 to 6.03	0.00 Percent change Interval -8.8 to 8.8	-1.96 Percent change Interval -6.62 to 2.69	0.00 Percent change Interval -6.53 to 6.53

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo QD n=8 Participants Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.	400 mg QD BI 730357 n=27 Participants Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	Placebo BID n=7 Participants Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	300 mg BID BI 730357 n=25 Participants Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	500 mg Ciprofloxacin (Active Comparator) n=12 Participants Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.
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)	7.19 Percent change Interval -16.27 to 30.66	-1.02 Percent change Interval -13.79 to 11.75	0.00 Percent change Interval -20.32 to 20.32	-12.45 Percent change Interval -23.2 to -1.69	3.69 Percent change Interval -15.46 to 22.85

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo QD n=8 Participants Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.	400 mg QD BI 730357 n=27 Participants Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	Placebo BID n=7 Participants Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	300 mg BID BI 730357 n=25 Participants Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	500 mg Ciprofloxacin (Active Comparator) n=12 Participants Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.
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)	-4.50 Percent change Interval -12.26 to 3.26	2.29 Percent change Interval -1.94 to 6.51	-2.85 Percent change Interval -12.36 to 6.66	-3.59 Percent change Interval -8.62 to 1.44	0.00 Percent change Interval -7.26 to 7.26

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo QD n=8 Participants Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.	400 mg QD BI 730357 n=27 Participants Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	Placebo BID n=7 Participants Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	300 mg BID BI 730357 n=25 Participants Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	500 mg Ciprofloxacin (Active Comparator) n=12 Participants Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.
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)	13.82 Percent change Interval -2.83 to 30.47	-12.82 Percent change Interval -21.88 to -3.76	0.00 Percent change Interval -18.53 to 18.53	-9.30 Percent change Interval -19.1 to 0.5	2.19 Percent change Interval -11.4 to 15.78

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo QD n=8 Participants Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.	400 mg QD BI 730357 n=27 Participants Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	Placebo BID n=7 Participants Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	300 mg BID BI 730357 n=25 Participants Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	500 mg Ciprofloxacin (Active Comparator) n=12 Participants Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.
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)	9.35 Percent change Interval -2.8 to 21.51	1.35 Percent change Interval -5.26 to 7.97	0.00 Percent change Interval -9.59 to 9.59	-2.84 Percent change Interval -7.92 to 2.23	-3.83 Percent change Interval -11.15 to 3.49

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo QD n=8 Participants Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.	400 mg QD BI 730357 n=27 Participants Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	Placebo BID n=7 Participants Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	300 mg BID BI 730357 n=25 Participants Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.	500 mg Ciprofloxacin (Active Comparator) n=12 Participants Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.
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)	10.71 Percent change Interval -3.52 to 24.95	-9.41 Percent change Interval -17.16 to -1.67	0.00 Percent change Interval -12.21 to 12.21	0.99 Percent change Interval -5.47 to 7.46	-27.91 Percent change Interval -39.53 to -16.29

Adverse Events

Placebo QD/BID

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

400 mg QD BI 730357

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

300 mg BID BI 730357

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

500 mg BID Ciprofloxacin (Active Comparator))

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

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Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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