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To evaluate the photosensitivity potential of BI 730357
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 730357 low dose | Experimental |
| |
| Ciprofloxacin | Active Comparator |
| |
| BI 730357 high dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 730357 | Drug | Film-coated tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | At 24 hours after irradiation on Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TKL Research, Inc. | Fair Lawn | New Jersey | 07410 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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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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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated Set (TS): The TS included all subjects who were randomized and treated with at least 1 dose of investigational product (IP) (BI 730357, placebo, or Ciprofloxacin). The TS was used for safety analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 400 mg QD BI 730357 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Unitless | At 24 hours after irradiation on Day 8 |
From start of treatment until end of the 7 day follow up period, 15 days in total.
Treated Set (TS): The TS included all subjects who were randomized and treated with at least 1 dose of investigational product (IP) (BI 730357, placebo, or Ciprofloxacin). The TS was used for safety analyses.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo QD/BID | Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days or three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 1, 2020 | Aug 30, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 23, 2020 | Aug 30, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Placebo to match BI 730357 |
| Drug |
Film-coated tablet |
|
| Ciprofloxacin | Drug | Film-coated tablet |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | At baseline and at 24 hours |
| Withdrawal by Subject |
|
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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Unknown or Not Reported group is actually Other | Count of Participants | Participants |
|
| Minimum Erythema Dose (MED) at baseline under condition 1 | MED defined as lowest dose that produced uniform redness (condition 1) (assessed in mJ for UVB/UVA). Condition 1: under full range solar UVB/UVA (290 to 400 nm, UBV content ~10%), simulating midday summer outdoor sun exposure (assessed in μw/cm2) Subjects were exposed to series of 6 graded full range solar UVB/UVA exposures, each 25% greater than previous dose. Outpatient irradiation and baseline MED testing for Irradiation Condition 1 occurred on Day -2. Two areas of back were defined for irradiation, followed by MED assessments at 24 hours (±10) minutes (Day -1) post irradiation. | 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. | Mean | Standard Deviation | millijoules/squarecentimeter |
|
| Minimum Erythema Dose (MED) at baseline under condition 2 | MED = lowest dose that produced uniform darkening (condition 2 C2) (in J for UVA). C2: UVA only (320 to 400 nm, UVB content <0.03%), simulating indoor exposure behind window glass with 2. assessment of erythema + local skin reactions at 25 Joules per centimetres-2 (J cm-2) (assessed in mw/cm2) Subjects exposed to series of 6 graded full range solar UVA exposures, each 25% greater than previous dose. Outpatient irradiation and baseline MED testing for Irradiation C2 occurred Day -2. Two areas of back defined for irradiation, MED assessments at 24 hours (±10) minutes (Day -1) post irradiation. | 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. | Mean | Standard Deviation | Joules/squarecentimeter |
|
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| Primary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Unitless | At 24 hours after irradiation on Day 8 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Unitless | At 10 minutes after irradiation on Day 8 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Unitless | At 10 minutes after irradiation on Day 8 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Unitless | At 1 hour after irradiation on Day 8 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Unitless | At 1 hour after irradiation on Day 8 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | At baseline (Day -2) and at 10 minutes after irradiation on Day 8 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | At baseline (Day -2) and at 10 minutes after irradiation on Day 8 |
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|
| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | At baseline (Day -2) and at 1 hour after irradiation on Day 8 |
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|
|
|
| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | At baseline (Day -2) and at 1 hour after irradiation on Day 8 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | At baseline (Day -2) and at 24 hours after irradiation on Day 8 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | At baseline and at 24 hours |
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| 0 |
| 18 |
| 0 |
| 18 |
| 7 |
| 18 |
| EG001 | 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. | 0 | 27 | 0 | 27 | 9 | 27 |
| EG002 | 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. | 0 | 28 | 0 | 28 | 11 | 28 |
| EG003 | 500 mg BID 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 in total) over 5 days from day 3 with a single dose 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. | 0 | 12 | 0 | 12 | 4 | 12 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
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.
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values | Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | Mean Difference (Final Values) | 0.01 | Standard Error of the Mean | 0.124 | 2-Sided | 90 | -0.20 | 0.22 | Equivalence | Two-sided 90% CI with an acceptance range of -0.4 to 0.4 |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | <0.001 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | -0.51 | Standard Error of the Mean | 0.102 | 2-Sided | 90 | -0.72 | -0.31 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | <0.001 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 0.52 | Standard Error of the Mean | 0.138 | 2-Sided | 90 | 0.24 | 0.80 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.010 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | -0.35 | Standard Error of the Mean | 0.132 | 2-Sided | 90 | -0.62 | -0.09 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.001 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 0.59 | Standard Error of the Mean | 0.173 | 2-Sided | 90 | 0.24 | 0.93 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.998 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 0.00 | Standard Error of the Mean | 0.038 | 2-Sided | 90 | -0.08 | 0.08 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.618 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 0.02 | Standard Error of the Mean | 0.050 | 2-Sided | 90 | -0.08 | 0.13 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values | Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | Mean Difference (Final Values) | 0.06 | Standard Error of the Mean | 0.099 | 2-Sided | 90 | -0.10 | 0.23 | Equivalence | Two-sided 90% CI with an acceptance range of -0.4 to 0.4 |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.451 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 0.06 | Standard Error of the Mean | 0.081 | 2-Sided | 90 | -0.10 | 0.23 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 1.000 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 0.00 | Standard Error of the Mean | 0.110 | 2-Sided | 90 | -0.22 | 0.22 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.446 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 0.10 | Standard Error of the Mean | 0.131 | 2-Sided | 90 | -0.16 | 0.36 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.972 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 0.01 | Standard Error of the Mean | 0.172 | 2-Sided | 90 | -0.34 | 0.35 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values | Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | Mean Difference (Final Values) | 0.29 | Standard Error of the Mean | 0.182 | 2-Sided | 90 | -0.02 | 0.60 | Equivalence | Two-sided 90% CI with an acceptance range of -0.4 to 0.4 |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.091 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 0.26 | Standard Error of the Mean | 0.150 | 2-Sided | 90 | -0.04 | 0.56 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.880 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 0.03 | Standard Error of the Mean | 0.203 | 2-Sided | 90 | -0.38 | 0.44 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.757 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | -0.01 | Standard Error of the Mean | 0.037 | 2-Sided | 90 | -0.09 | 0.06 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.158 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | -0.07 | Standard Error of the Mean | 0.049 | 2-Sided | 90 | -0.17 | 0.03 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values | Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | Mean Difference (Final Values) | 0.05 | Standard Error of the Mean | 0.101 | 2-Sided | 90 | -0.12 | 0.22 | Equivalence | Two-sided 90% CI with an acceptance range of -0.4 to 0.4 |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.330 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 0.08 | Standard Error of the Mean | 0.083 | 2-Sided | 90 | -0.09 | 0.25 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.754 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | -0.04 | Standard Error of the Mean | 0.113 | 2-Sided | 90 | -0.26 | 0.19 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.151 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 0.16 | Standard Error of the Mean | 0.110 | 2-Sided | 90 | -0.06 | 0.38 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.319 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 0.15 | Standard Error of the Mean | 0.145 | 2-Sided | 90 | -0.15 | 0.44 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values | Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | Mean Difference (Final Values) | 0.19 | Standard Error of the Mean | 0.136 | 2-Sided | 90 | -0.04 | 0.42 | Equivalence | Two-sided 90% CI with an acceptance range of -0.4 to 0.4 |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.246 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 0.13 | Standard Error of the Mean | 0.112 | 2-Sided | 90 | -0.09 | 0.36 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.704 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 0.06 | Standard Error of the Mean | 0.151 | 2-Sided | 90 | -0.25 | 0.36 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.630 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | -1.96 | Standard Error of the Mean | 4.048 | 2-Sided | 90 | -10.14 | 6.21 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 1.000 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 0.00 | Standard Error of the Mean | 5.482 | 2-Sided | 90 | -11.07 | 11.07 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.751 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | -1.44 | Standard Error of the Mean | 4.518 | 2-Sided | 90 | -10.55 | 7.66 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.669 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 1.68 | Standard Error of the Mean | 3.894 | 2-Sided | 90 | -6.17 | 9.52 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.546 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | -3.12 | Standard Error of the Mean | 5.123 | 2-Sided | 90 | -13.44 | 7.21 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.092 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | -16.14 | Standard Error of the Mean | 9.350 | 2-Sided | 90 | -35.02 | 2.74 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.772 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 3.69 | Standard Error of the Mean | 12.662 | 2-Sided | 90 | -21.88 | 29.27 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.539 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | -8.21 | Standard Error of the Mean | 13.255 | 2-Sided | 90 | -34.93 | 18.50 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.682 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | -4.71 | Standard Error of the Mean | 11.424 | 2-Sided | 90 | -27.74 | 18.31 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.817 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | -3.50 | Standard Error of the Mean | 15.030 | 2-Sided | 90 | -33.79 | 26.79 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.417 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | -3.59 | Standard Error of the Mean | 4.375 | 2-Sided | 90 | -12.42 | 5.25 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.633 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 2.85 | Standard Error of the Mean | 5.925 | 2-Sided | 90 | -9.11 | 14.82 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.129 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 6.79 | Standard Error of the Mean | 4.384 | 2-Sided | 90 | -2.05 | 15.62 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.548 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 2.29 | Standard Error of the Mean | 3.778 | 2-Sided | 90 | -5.33 | 9.90 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.370 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 4.50 | Standard Error of the Mean | 4.970 | 2-Sided | 90 | -5.51 | 14.52 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.185 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | -11.49 | Standard Error of the Mean | 8.524 | 2-Sided | 90 | -28.70 | 5.73 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.851 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 2.19 | Standard Error of the Mean | 11.544 | 2-Sided | 90 | -21.12 | 25.50 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.007 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | -26.64 | Standard Error of the Mean | 9.405 | 2-Sided | 90 | -45.59 | -7.69 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.071 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | -15.01 | Standard Error of the Mean | 8.106 | 2-Sided | 90 | -31.34 | 1.33 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.281 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | -11.63 | Standard Error of the Mean | 10.664 | 2-Sided | 90 | -33.13 | 9.86 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.824 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 0.99 | Standard Error of the Mean | 4.410 | 2-Sided | 90 | -7.92 | 9.90 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.525 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | -3.83 | Standard Error of the Mean | 5.973 | 2-Sided | 90 | -15.90 | 8.23 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.250 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | -8.00 | Standard Error of the Mean | 6.867 | 2-Sided | 90 | -21.84 | 5.84 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.386 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 5.19 | Standard Error of the Mean | 5.919 | 2-Sided | 90 | -6.74 | 17.12 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.097 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | -13.19 | Standard Error of the Mean | 7.787 | 2-Sided | 90 | -28.88 | 2.51 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | <0.001 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 28.90 | Standard Error of the Mean | 5.619 | 2-Sided | 90 | 17.55 | 40.25 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | <0.001 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | -27.91 | Standard Error of the Mean | 7.610 | 2-Sided | 90 | -43.28 | -12.54 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.016 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | -20.13 | Standard Error of the Mean | 8.041 | 2-Sided | 90 | -36.33 | -3.92 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | 0.011 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | 18.50 | Standard Error of the Mean | 6.931 | 2-Sided | 90 | 4.53 | 32.46 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |
| Linear mixed model | Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect | <0.001 | P-value is for testing Least Squares Mean Difference=0 | Mean Difference (Final Values) | -38.62 | Standard Error of the Mean | 9.118 | 2-Sided | 90 | -57.00 | -20.25 | Other | Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values |