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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

This Study in Healthy Men and Women Tests Whether BI 409306 Has an Effect on the ECG (Thorough QT Study)

Clinicaltrials.gov identifier NCT03934203

Recruitment Status Completed

First Posted May 1, 2019

Last update posted September 17, 2019

Study Description

Brief summary:

The primary objective of this trial is to assess the effect of BI 409306 on the QT/QTc interval in healthy male and female volunteers as measured by the QTcF change from baseline compared with placebo. Secondary objectives are to show the assay sensitivity of the trial, by reproducing the typical effect of the positive control moxifloxacin on the QT/QTc interval, and to assess the effect of BI 409306 on heart rate.

  • Condition or Disease:Healthy
  • Intervention/Treatment: Drug: BI 409306
    Drug: Moxifloxacin
    Drug: Placebo matching to BI 409306
  • Phase: Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 47 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment
  • Official Title: Thorough QT Study to Evaluate the Effects of BI 409306 as Single Dose on Cardiac Safety Parameters in Healthy Male and Female Subjects. A Randomized, Placebo Controlled, Double-blind, Five-period Crossover Study With (Open-label) Moxifloxacin as Positive Control
  • Actual Study Start Date: May 2019
  • Actual Primary Completion Date: September 2019
  • Actual Study Completion Date: September 2019
Arms and interventions
Arm Intervention/treatment
Experimental: Treatment 1
Drug: BI 409306
Film-coated tablet

Drug: Placebo matching to BI 409306
Film-coated tablet
Experimental: Treatment 2
Drug: BI 409306
Film-coated tablet
Experimental: Treatment 3
Drug: Moxifloxacin
Film-coated tablet
Experimental: Treatment 4
Drug: Placebo matching to BI 409306
Film-coated tablet
Outcome Measures
  • Primary Outcome Measures: 1. The maximum mean difference between each single dose of BI 409306 and placebo in QTcF changes [ Time Frame: Baseline and up to 24 hours ]
  • Secondary Outcome Measures: 1. The maximum mean difference between moxifloxacin and placebo in QTcF changes from baseline [ Time Frame: Baseline and up to 24 hours ]
  • 2. The maximum mean difference between each single dose of BI 409306 and placebo in heart rate (HR) changes from baseline [ Time Frame: Baseline and up to 24 hours ]
  • 3. The minimum mean difference between each single dose of BI 409306 and placebo in HR changes from baseline [ Time Frame: Baseline and up to 24 hours ]
Eligibility Criteria
  • Ages Eligible for Study: 18 to 50 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- Healthy male or female subjects according to the assessment of the investigator, based
on a complete medical history including a physical examination, vital signs (Blood
Pressure (BP), Pulse Rate (PR)), 12-lead single Electrocardiogram (ECG) and 12-lead
Holter Electrocardiogram (ECG), and clinical laboratory tests

- Age of 18 to 50 years (incl.)

- Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)

- Signed and dated written informed consent prior to admission to the study in
accordance with Good clinical practice (GCP) and local legislation

- Male subjects, or female subjects who meet any of the following criteria starting from
at least 30 days before the first administration of trial medication and until 30 days
after trial completion:

- Use of adequate contraception, e.g. non-hormonal intrauterine device plus condom

- Sexually abstinent

- A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)

- Surgically sterilised (including hysterectomy)

- Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in
questionable cases a blood sample with simultaneous levels of FSH above 40 U/L
and estradiol below 30 ng/L is confirmatory)

Exclusion Criteria:

- Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR)
or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant
by the investigator

- Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg,
diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the
range of 45 to 90 bpm

- Any laboratory value outside the reference range that the investigator considers to be
of clinical relevance

- Any evidence of a concomitant disease judged as clinically relevant by the
investigator

- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
immunological or hormonal disorders

- Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with
the pharmacokinetics of the trial medication (except appendectomy and simple hernia
repair)

- Diseases of the central nervous system (including but not limited to any kind of
seizures or stroke), and other relevant neurological or psychiatric disorders

- History of relevant orthostatic hypotension, fainting spells, or blackouts

- Chronic or relevant acute infections

- History of relevant allergy or hypersensitivity (including allergy to the trial
medication or its excipients)

- Further exclusion criteria apply

Contacts and Locations
Contacts
Locations

Germany
Humanpharmakologisches Zentrum Biberach
Biberach

Sponsors and Collaborators

Boehringer Ingelheim

More Information
  • Responsible Party: Boehringer Ingelheim
  • ClinicalTrials.gov Identifier: NCT03934203 History of Changes
  • Other Study ID Numbers: 1289-0038, 2018-001335-44
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: September 17, 2019
  • Last Verified: September 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/
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No