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

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ClinicalTrials.gov Identifier: NCT04147260
Recruitment Status : Recruiting
First Posted : November 1, 2019
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To evaluate the photosensitivity potential of BI 730357

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 730357 Drug: Placebo to match BI 730357 Drug: Ciprofloxacin Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Partially-blind, Randomized, Parallel Group, Placebo and Active Comparator-controlled Phase I Clinical Trial to Evaluate the Photosensitivity Potential of BI 730357
Actual Study Start Date : November 6, 2019
Estimated Primary Completion Date : January 24, 2020
Estimated Study Completion Date : January 24, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment A
BI 730357 or Placebo
Drug: BI 730357
Film-coated tablet

Drug: Placebo to match BI 730357
Film-coated tablet

Active Comparator: Treatment B
Ciprofloxacin
Drug: Ciprofloxacin
Film-coated tablet




Primary Outcome Measures :
  1. Phototoxicity index at 24 h under condition 1 [ Time Frame: Up to 24 hours ]
    Condition 1 is full range solar UVB/UVA exposures

  2. Phototoxicity index at 24 h under condition 2 [ Time Frame: Up to 24 hours ]
    Condition 2 is UVA exposure only


Secondary Outcome Measures :
  1. Phototoxicity index at 10 min under condition 1 [ Time Frame: Up to 10 minutes ]
    Condition 1 is full range solar UVB/UVA exposures

  2. Phototoxicity index at 1 h under condition 1 [ Time Frame: Up to 1 hour ]
    Condition 1 is full range solar UVB/UVA exposures

  3. Phototoxicity index at 10 min under condition 2 [ Time Frame: Up to 10 minutes ]
    Condition 2 is UVA exposure only

  4. Phototoxicity index at 1 h under condition 2 [ Time Frame: Up to 1 hour ]
    Condition 2 is UVA exposure only

  5. MED percent change from baseline at 10min, 1h, and 24h measured under condition 1 and condition 2 [ Time Frame: Up to 24 hours ]
    Condition 1 is full range solar UVB/UVA exposures. Condition 2 is UVA exposure only



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female subjects according to the assessment of the Investigator, based on a complete medical history, physical examination (including dermatological skin type assessment), vital signs (blood pressure, pulse rate), 12-lead ECG, and clinical laboratory tests
  • 18 to 55 years old
  • BMI 18 to 35 kg/m (incl.)
  • Fitzpatrick skin type I, II, or III:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04147260


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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United States, New Jersey
TKL Research, Inc. Recruiting
Fair Lawn, New Jersey, United States, 07410
Contact: Jonathan Dosik    +001 (201) 587-0505    jdosik@tklresearch.com   
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04147260     History of Changes
Other Study ID Numbers: 1407-0037
First Posted: November 1, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

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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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors