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

NCT04147260 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 1407-0037
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the photosensitivity potential of BI 730357

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (10)

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

  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)

  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)

  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)

  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)

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

Study Arms (4)

BI 730357 low dose

EXPERIMENTAL

Drug: BI 730357

Ciprofloxacin

ACTIVE COMPARATOR

Drug: Ciprofloxacin

BI 730357 high dose

EXPERIMENTAL

Drug: BI 730357

Placebo

PLACEBO COMPARATOR

Drug: Placebo to match BI 730357

Interventions

BI 730357 DRUG

Film-coated tablet

BI 730357 high dose; BI 730357 low dose

Placebo to match BI 730357 DRUG

Film-coated tablet

Placebo

Ciprofloxacin DRUG

Film-coated tablet

Ciprofloxacin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• to 55 years old
• BMI 18 to 35 kg/m (incl.)
• Fitzpatrick skin type I, II, or III:
• I Always burns easily, never tans
• II Always burns easily, tans minimally
• III Burns moderately, tans gradually
• No ultraviolet exposure of the test areas 4 weeks prior to baseline photo testing
• Normal skin response during preliminary photo testing.
• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
• Women of childbearing potential (WOCBP)1 must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information

You may not qualify if:

• Any finding in the medical examination (including blood pressure, pulse rate or ECG) deviating from normal and judged as clinically relevant by the Investigator.
• Any laboratory value outside the reference range that the Investigator considers to be of clinical relevance.
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders or any evidence of a concomitant disease judged as clinically relevant by the Investigator.
• Major surgery (major according to the investigator's assessment) performed within 10 weeks prior to randomisation or planned within 2 months after screening.
• Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix.
• Active skin disorders on the back where photosensitivity testing will be performed.
• Subjects who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
• Subjects not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the subject an unreliable trial participant).
• Currently enrolled in another investigational device or drug trial, or less than 30 days (or 5 half-lives (whichever longer)) since ending another investigational drug trial.
• Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
• History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients).
• History of hypersensitivity to ciprofloxacin, any member of the quinolone class of antibacterials.
• History of hypersensitivity to sunlight or artificial source of intense light, especially UV light.
• Chronic or acute infections which are of relevance in the opinion of the Investigator.
• Positive result for HIV, HBV, and hepatitis C (Hep C) at screening.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

TKL Research, Inc.

Fair Lawn, New Jersey, 07410, United States

Location

Related Links

• Related Info

MeSH Terms

Interventions

Ciprofloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 1, 2019
• Study Start: November 6, 2019
• Primary Completion: September 9, 2020
• Study Completion: September 9, 2020
• Last Updated: July 17, 2023
• Results First Posted: July 17, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)